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For use under the Emergency Use Authorization only

For in vitro diagnostic use

For Prescription Use Only

STORAGE: Store at 2 to 30°C (36 to 86°F)

Instructions for Use

DPP® Ebola Antigen System

Cat. No. 61-1013-0 20 Test Kit 

A qualitative test kit with 20 devices for the rapid detection of antigen specific to Ebola virus (species Zaire 

ebolavirus) in capillary “fingerstick” whole blood, EDTA venous whole blood and EDTA plasma.

1. Intended Use

The DPP Ebola Antigen System is a rapid, single-use immunochromatographic test intended for the qualitative 

detection of VP40 protein from Ebola virus (species Zaire ebolavirus and hereafter referred to as Ebola virus) in 

capillary “fingerstick” whole blood, EDTA venous whole blood, and EDTA plasma. 

The DPP Ebola Antigen System is for the presumptive detection of Ebola virus in individuals with signs and 

symptoms of Ebola virus disease (EVD) in conjunction with epidemiological risk factors (including geographic 

locations with high prevalence of EVD). The DPP Ebola Antigen System is intended for circumstances when use of a 

rapid Ebola test is determined to be more appropriate than use of an Ebola nucleic acid test, which has been 

demonstrated to be more sensitive in detecting the Ebola virus. The DPP Ebola Antigen System is not intended for 

use for general EVD screening, such as airport screening or contact tracing of individuals without signs and 

symptoms of EVD. The DPP Ebola Antigen System is intended for use in laboratories or facilities adequately 

equipped, trained and capable of such testing (including treatment centers and public health clinics).

Testing with the DPP Ebola Antigen System should not be performed unless the patient meets clinical and 

epidemiologic criteria for testing suspect specimens. Negative results do not preclude EVD and should not be used 

as the sole basis for patient management decisions. The definitive identification of EVD requires additional testing 

and confirmation procedures in consultation with public health or other authorities for whom reporting is 

required. The diagnosis of EVD must be made based on history, signs, symptoms, exposure likelihood, and other 

laboratory evidence in addition to the identification of Ebola virus.

The level of Ebola virus antigens that would be present in the clinical specimen from individuals with early systemic 

infection is unknown. The DPP Ebola Antigen System was evaluated in a limited clinical study using retrospective 

clinical specimens from individuals with EVD confirmed by RT-PCR.

2. Test Principle

The DPP Ebola Antigen System is composed of 

1. A single-use immuno-chromatographic, rapid test developed on Chembio’s patented DPP® technology 

(US/7189522 and WO/2006/099191).

2. The DPP® Micro Reader which is used to interpret test results.

The DPP® Ebola Antigen System is a qualitative test for the detection of VP40 antigen specific to Ebola Virus in 

capillary “fingerstick” whole blood, EDTA venous whole blood and EDTA plasma. The DPP Ebola Antigen System 
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employs a unique combination of antibodies, specific to Ebola virus antigens, which are conjugated to colloidal 

gold dye particles and bound to the membrane solid phase. To perform the test, the device should be removed 

from its pouch and placed on a flat surface. A blue test line and green control line should be noted in the device’s 

rectangular TEST and CONTROL window. If the blue test line and green control line are absent (partially or 

completely) or defective (scratched), the test device should be discarded and replaced with a new one. 50uL of 

sample is obtained from the patient and added to the SAMPLE + BUFFER Well 1 of the device. Immediately 

following sample addition, 3 drops of buffer are added to the SAMPLE + BUFFER Well 1. In a properly performing 

device, when the sample and buffer are added to the SAMPLE + BUFFER Well 1 of the test device, upon the 

sample/buffer migration along the test strip to the test site (i.e. the rectangular TEST and CONTROL window), the 

blue and green dye at the test site becomes diluted and invisible to the naked eye, thereby indicating that the 

sample and buffer have properly migrated across the TEST and CONTROL areas, allowing for the capture of Ebola 

virus antigens, if present in the sample. After the sample and buffer have migrated onto the test strip (after 5 

minutes), 6 drops of buffer are added to the BUFFER Well 2. The buffer solubilizes the gold nanoparticles 

conjugated to mouse antibodies against Ebola virus antigen and carries the conjugate across the TEST and 

CONTROL areas. The test results are interpreted using the DPP Micro Reader between 10 and 15 minutes after 

Running Buffer is added to BUFFER Well 2. The DPP Micro Reader is a reflectance reader for use with the DPP 

Ebola Antigen System that uses assay-specific algorithms to analyze the test and control line reflectance to 

determine the presence or absence of VP40 antigen specific to Ebola virus in the sample. The reader verifies the 

presence of the control line and measures color intensity at each of the test line positions; it interprets the results 

using an algorithm including assay-specific cut-off values, and reports a reactive (EVD+), non-reactive (EVD-), or 

invalid (INV) result after approximately 3 seconds. The results are displayed through a 14-segment liquid crystal 

display (LCD) on the top of the instrument. 

3. Kit Contents

Each kit contains the items to perform 20 tests:

• 20 DPP Ebola Antigen System Test Devices - Individually Pouched 

o Each DPP® Ebola Antigen System Test Device contains membrane immobilized with a capture 

antibody raised against Ebola Virus VP40 antigen in the TEST (T) area and IgG antibody in the 

CONTROL (C) area; one clinical specimen result per test device.

o 1 Desiccant Pouch, 1 gram

• 20 Disposable Microsafe® Tubes (50 μL) 

• 20 Sterile Safety Lancets (for fingerstick whole blood samples)

• 20 Adhesive Bandages

• 20 Sterile Alcohol Swabs

• 1 DPP® Ebola Antigen System Buffer (7 mL) – Green Cap

• 1 Product Insert

• 1 Quick Reference Instructions

• 1 Fact Sheet for Healthcare Providers

• 1 Fact Sheet for Patients

4. Accessories that are available and required include

• DPP® Micro Reader (Catalog # 61-1050-0)

Each contains:

o 1 Chembio DPP Micro Reader with Ebola RFID sticker (includes 3 Lithium-ion, type CR2032 (3 V/230 

mAh) coin cell batteries)

o 1 DPP Cartridge Holder for use with DPP Ebola Antigen Test Device

o 1 Custom Power Cable (USB)

o 1 Power plug adapter

o 1 Microfiber Cloth
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o 1 User Manual for the DPP Micro Reader

• DPP® Ebola Rapid Test Control Pack (Catalog #60-9554-0)

Each contains:

o DPP® Ebola Reactive Control (0.5mL) 

o Lyophilized heat inactivated Recombinant Ebola virus VP40 protein (600 ng/ mL) in normal 

human serum negative for HBsAg, HCV Ab, HIV 1/2 ag, HBV DNA, HCV RNA, HIV RNA, RPR 

(syphilis) and preservative (0.09% sodium azide).

o DPP® Ebola Non-Reactive Control (0.5mL) 

o Lyophilized normal human serum negative for HBsAg, HCV Ab, HIV 1/2 ag, HBV DNA, HCV RNA, 

HIV RNA, RPR (syphilis) and preservative (0.09% sodium azide).

5. Materials Required But Not Provided

• Clock, watch or other timing device

• Disposable gloves

• Sterile gauze (for fingerstick samples only)

• Collection devices (for venous whole blood or serum/plasma specimens)

• Biohazard disposal containers

• Pipettor capable of delivering 20-200μL of sample (for other than fingerstick specimens)

• Pipette tips

6. Storage and Shelf Life

• The DPP® Ebola Antigen System should be stored in unopened pouches at 2 °C to 30 °C (36 °F to 86 °F). Do not

freeze. 

• Do not use beyond the indicated expiration date. Test devices are stable until the expiration date marked on 

the pouch, when stored as indicated. 

• DPP® Ebola Antigen System Buffer bottles should be stored at 2 °C to 30 °C (36 °F to 86 °F) in the original vial. 

• Do not open the pouch until ready to perform the test.

7. Precautions and Warnings

• For In Vitro Diagnostic Use under Emergency Use Authorization only.

• Samples positive for Rheumatoid Factor, Plasmodium malariae or Plasmodium ovale may yield erroneous 

results.

• Local, state, and national public health agencies (for example, county and state health departments or the U.S. 

Centers for Disease Control and Prevention (CDC) or World Health Organization (WHO) should be notified of 

any patient suspected to have EVD. Confirmatory testing at the state/local public health laboratory or at 

CDC/WHO is necessary for positive detection results and may be necessary for negative detection results. 

Laboratories should consult with local, state or national public health officials on any positive detection OR no 

detection (negative) EVD test result on the need for additional testing and appropriate transportation of 

specimens.

• Use of this assay should be limited to designated, trained personnel.

• All personnel who are involved in collecting, processing, handling, or transporting specimens from a patient 

with suspected Ebola virus disease (EVD) should take appropriate precautions following the procedures 

recommended by Centers for Disease Control and Prevention (CDC).1,2,3

• All persons entering the patient room should wear at least: Gloves, Gown (fluid resistant or impermeable), Eye 

Protection (goggles or face shield) and Facemask. Additional PPE might be required in certain situations (e.g., 

copious amounts of blood, other body fluids, vomit, or feces present in the environment), including but not 

limited to: double gloving, disposable shoe covers and leg coverings.
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• Do not eat, drink or smoke in the area where specimens and kit reagents are handled. Avoid any contact 

between hands, eyes or mouth during specimen collection and testing.

• Dispose of all specimens and materials used in the test procedure including the Quick Reference Guides in a 

biohazard waste container. Lancets should be placed in a sealed, puncture-resistant container prior to 

disposal. The recommended method of disposal of biohazard waste is autoclaving for a minimum of 1 hour at 

121 oC. Disposable materials may be incinerated. Liquid wastes may be mixed with appropriate chemical 

disinfectants. A freshly prepared solution of 10% bleach (0.5% solution of sodium hypochlorite) is 

recommended. Allow 60 minutes for effective decontamination (preferably overnight). Use 10% bleach or 

other appropriate disinfectant to wipe all spills. The bleach solution should be made fresh daily. NOTE: Do not 

autoclave solutions that contain bleach.

• Avoid Aerosol Generating Procedures (AGPs) for patients with EVD. 

• Patients should be placed in single patient room (containing a private bathroom) with the door closed.

• Dedicated medical equipment (preferably disposable, when possible) should be used for the provision of 

patient care.

• Do not use any device if the pouch has been perforated.

• Each device is for single use only.

• Always check expiration date prior to testing. Do not use the test beyond the expiration date printed on the 

pouch.

• If desiccant packet is missing, Do not use, discard and use a new test device. 

• Do not mix reagents from different lot numbers of kits.

• Adequate lighting is required to read the test results.

8. Sample Collection

• The DPP Ebola Antigen System is intended for the qualitative detection of VP40 antigen specific to Ebola virus 

in capillary “fingerstick” whole blood, EDTA venous whole blood, and EDTA plasma.

• Shipping should be performed according to the policies of the shipping performer, customs regulations, and 

the requirements of the receiving laboratory.

• Follow the recommended infection control precautions for Ebola or other hemorrhagic fever viruses in 

handling all specimens.

For Fingerstick Whole Blood:

Following laboratory procedures, clean the finger of the person being tested with the Sterile Alcohol Swab. Allow 

the finger to dry thoroughly or wipe dry with a sterile gauze pad. Using the Sterile Safety Lancet, puncture the skin 

just slightly off the center of the finger and wipe away the first drop of blood with sterile gauze. Avoid squeezing 

the fingertip to accelerate bleeding as this may dilute the blood with excess tissue fluid. Without squeezing the 

bulb, hold the Microsafe® Tube (Figure 1) in a horizontal position and touch the tip of the tube to the blood sample 

(Figure 2). Capillary action will draw the sample to the black fill line (50 uL). Be sure the tube is completely filled to 

the black line and there are no air bubbles (Figure 2).

Figure 1: Figure 2: Blood Filled Microsafe Tube

CAUTION: When drawing sample 

with the Microsafe Tube DO NOT

squeeze the bulb at the top of the 

tube. Capillary action will draw the 

sample to the black fill line.
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SAMPLE + BUFFER 

Well 1

For Venous Whole Blood:

Draw blood following laboratory procedure for obtaining venous blood. Depending on use, collect sample in a tube 

containing citrate, heparin or EDTA. Be sure the tube of blood is well mixed before sampling. If the specimen to be 

tested is refrigerated, remove it from the refrigerator and allow it to come to a temperature of 18 to 30°C (64 to 

86°F).

For Plasma:

Collect plasma in a tube containing EDTA following standard laboratory procedures. If the specimen to be tested is 

refrigerated, remove it from the refrigerator and allow it to come to a temperature of 18 to 30°C (64 to 86°F). 

9. Testing Procedure

1. Remove the DPP® Ebola Antigen System 

Test Device from its pouch and place it on a 

flat surface (it is not necessary to remove 

the Desiccant Packet from the pouch). 

Note: If Desiccant Packet is missing, DO 

NOT USE, discard Test Device and a new 

Test Device should be used.

Label the Test Device with patient ID or 

identification number. Note that the DPP®

Ebola Antigen System Test Device has 2 

colored lines in the Test Window; one is 

blue and the other is green. If the 2 colored 

lines are absent, DO NOT USE, discard Test 

Device and a new Test Device should be 

used.

IMPORTANT: When adding the Sample into 

Well 1, be sure to dispense onto the white 

absorbent pad.

2. For Fingerstick Whole Blood:

Holding the Microsafe Tube vertically over 

the SAMPLE+BUFFER Well 1, squeeze the 

bulb to release 50 μL sample into the well. 

Immediately continue onto Step 3.

IN THE EVENT THAT THE SAMPLE DOES 

NOT COME OUT OF THE TUBE, hold the 

tube vertically and slide a finger over the 

vent hole near the black mark. Then line up 

the Microsafe Tube tip with Well 1 and 

squeeze the bulb.

 

 

Test Window 

with blue and 

green lines

BUFFER

Well 2

 

1234567
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For Venous Whole Blood or Plasma:

Using a calibrated pipette, add 50 μL of 

the sample to Sample + Buffer Well 1.

 

3. Immediately after the addition of the 

sample, add 3 drops of DPP Ebola Antigen 

System Buffer (Green Cap) into the same 

well (Well 1). To add the buffer, invert the 

DPP Ebola Antigen System Buffer bottle 

(Green Cap) and hold it vertically (not at an 

angle) over Well 1. Squeeze the bottle to 

slowly add 3 drops. 

4. Wait 5 minutes. The blue colored line 

should have disappeared from the 

rectangular TEST and CONTROL window. If 

not, DO NOT USE, discard Test Device and 

use a new Test Device. The green colored 

line may or may not disappear.

Invert the DPP Ebola Antigen System Buffer 

bottle (Green Cap) and hold it vertically (not 

at an angle) over BUFFER Well 2. Add 6

drops of Buffer (Green Cap) slowly, 

dropwise, into BUFFER Well 2.

A pink color should begin to flow across 

the strip within 2-3 minutes. If NO PINK 

flow is present, repeat with a new device.

5. Wait 10 minutes. Read the test result (see INTERPRETATION OF RESULTS section) 10-15 minutes from the addition of 

DPP Ebola Antigen System Buffer into Well 2. DO NOT read results after 15 minutes from the addition of DPP Ebola

Antigen System Buffer into Well 2.

NOTE: The test result should be manually recorded immediately after the test is complete as the reader will turn off 

automatically after approximately 50 seconds of inactivity. The DPP Micro Reader device does not store or recall 

previous results.

Test Results are read using the DPP Micro Reader.

DO NOT ATTEMPT TO INTERPRET THE RESULTS VISUALLY. 

ALWAYS USE THE DPP MICRO READER TO OBTAIN THE RESULTS.
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Using the DPP Micro Reader

Components of the DPP Micro Reader

• DPP Micro Reader with Ebola RFID sticker

• Cartridge Holder for use with the DPP Ebola Antigen System Test Device

• USB Cable

• 1 Power plug adapter

• 1 Microfiber Cloth

• 1 User Manual for the DPP Micro Reader

Assemble the DPP Micro Reader

a) Check to make sure that the window at the bottom of the reader is clean of finger marks and dust or lint before 

using the reader. Use enclosed microfiber cloth to wipe free of marks, dust or debris following the Chembio 

Ebola Micro Reader User Manual instructions. 

Make sure the RFID Sticker refers to Ebola VP40.

Place the Cartridge Holder on a flat surface. Align the angled edge in the bottom of the DPP Micro Reader with 

the corresponding angled corner of the holder socket and place the DPP Micro Reader in the holder socket.

b) To read a test, place the DPP® Micro Reader in Cartridge Holder on top of the Test Device. Make sure the 

rectangular test window on the Test Device is aligned with the reading window of the reader. At the end of 

assembly, the black button, battery compartment and Buffer Well 1 on the test device should be facing the user 

and Buffer Well 2 should be to the left of the user.

Openings for 

Wells 1 and 2 Reader Opening

Angled Corner

Angled Edge

DPP Ebola Ag 

RFID Sticker

DPP Micro Reader

DPP Micro Reader

Cartridge Holder for Reader DPP Micro Reader in Holder

DPP Micro Reader with Cartridge 

Holder on top of testing device
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Reading the test:

a) 10 to 15 minutes after the addition of the DPP 

Ebola Antigen System Buffer to Well 2 as per STEP 

4, push the operating button. “ON” should 

appear in the reading window. 

b) Press the Operating Button again; the display will read “RFID”. 

c) “TEST” will appear in the display window.

d) Press the Operating Button and “RUN” will appear in the display window. 

After approximately 3 seconds, a result for the DPP Ebola Antigen System Test Device will appear across the display. 

Record the result (refer to INTERPRETATION OF TEST RESULTS) as the reader does not record results.

If the DPP Micro Reader does not detect a line in the CONTROL (C) area, then it will display “INV”, indicating that the test 

is INVALID. An INVALID result indicates a problem with running the test, either related to the specimen, the device, or the 

procedure followed. An INVALID test cannot be interpreted; it is recommended that the INVALID test be repeated with a 

new device.

10. Interpretation of Test Results

All test controls should be examined prior to interpretation of patient results. If the controls are not valid, the 

patient results cannot be interpreted. 

Interpretation of Internal and External Controls 

Internal Control 

• Upon opening of test pouch, user should see a blue and green line printed in the test window. If lines are not 

present, user should discard device and use a new Test Device.

Reading Window

Push this 

Button
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• When sample and buffer is added to well #1, these lines should disappear from the test window. If they do not, 

the user is to discard the Test Device and use a new Test Device.

• Regardless if a line develops in the test area (T), a line must develop in the CONTROL area (C). If a line does not 

develop in the CONTROL area, the test is not performing correctly and is INVALID. An invalid test cannot be 

interpreted; it is recommended that the invalid test be repeated with a new device. The reader will display 

“INVALID” and not give a result.

External Control 

The DPP Ebola Rapid Test Control Pack is a set of external controls. The DPP Ebola Rapid Test Control Pack

is manufactured specifically for use with the DPP Ebola Antigen System. One package of the DPP Ebola 

Rapid Test Control Pack contains 1 DPP Ebola Reactive Control (lyophilized), 1 DPP Ebola Non-Reactive 

Control (lyophilized), and 1 Product Insert for external controls. 

Run the External Controls under the following circumstances:

• Each new operator prior to performing tests on patient samples

• When opening a new test kit lot

• Whenever a new shipment of test kits is received

• If the temperature of the test storage area falls outside of 2 to 30°C (36 to 86°F)

• If the temperature of the testing area falls outside of 18 to 30°C (64 to 86°F)

• At periodic intervals as dictated by local, state and country laws and by the user facility.

If external controls do not produce expected results as stated in the section 13 below “External Quality Control” on 

page 11, patient testing should not be performed. Contact Chembio Diagnostic Systems’ Customer Service at 1-

844-CHEMBIO (243-6246) if the Kit Control reagents do not produce the expected results.

INTERPRETATION DISPLAY ON READER

NON-REACTIVE (EVD -)

A NON-REACTIVE Test Result means that Ebola virus VP40 antigen 

was not detected in the specimen. The Test Result is interpreted 

as NEGATIVE. 

A NON-REACTIVE result does not exclude possible infection with 

Ebola virus. As with any test, providers must consider the 

patient’s likelihood of exposure and the possibility of false 

laboratory results when making treatment or other patient 

management decisions.

REACTIVE (EVD +)

A REACTIVE Test Result means Ebola virus VP40 antigen has been 

detected in the specimen. The Test Result is interpreted as 

Presumptive POSITIVE for possible infection with Ebola virus.

Individuals with a reactive DPP Ebola Antigen System Test Result 

should undergo appropriate clinical follow-up which may include 

supplemental PCR testing.

EVD -

EVD +
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11. Assay Limitations

• All results should be interpreted by a trained professional in conjunction with the patient’s history and clinical 

signs and symptoms, and epidemiological risk factors. 

• Interpretation of results from the DPP Ebola Antigen System must account for the possibility of false-negative 

and false-positive results. 

• Negative results do not preclude infection with Ebola virus and should not be the sole basis of a patient 

treatment/management or public health decision. 

• False positive results may occur from cross-contamination by target organisms or other pathogens.

• Failure to follow the assay procedures may lead to false negative results. 

• Improper collection, storage, or transport of specimens may lead to false negative results. 

• Inhibitors present in the samples may lead to false negative results. 

• Reading test results earlier than 10 minutes or later than 15 minutes after the addition of Running Buffer to 

Well 2 may yield erroneous results.

• Do not open the sealed foil pouch until just prior to use.

• Do not use kit contents beyond labeled expiration date.

• Performing fingerstick sample collection when the finger is not completely dry could result in the 

contamination or dilution of the sample.

• Results should be read in a well-lit area.

• Results must be read with the DPP Micro Reader.

• The test is not validated as a quantitative test for treatment monitoring. 

• Performance of this assay has only been established for EDTA venous whole blood and Fingerstick whole 

blood or EDTA plasma. Performance with other specimen types has not been evaluated. 

• This test should not be used to test specimens from asymptomatic individuals. 

• The definitive identification of Ebola virus disease (EVD) requires additional testing and confirmation 

procedures in consultation with public health or other authorities for whom reporting is required. 

• The diagnosis of EVD must be made based on history, signs, symptoms, exposure likelihood, and other 

laboratory evidence in addition to the identification of Ebola virus.

• Samples positive for Plasmodium malariae or Plasmodium ovale may yield erroneous results.

• Concentrations of Rheumatoid Factor above 125 IU/mL in the sample may cause interference in the assay.

• Cross-reactivity with organisms other than those tested in the Cross-reactivity Study has not been assessed 

and may lead to erroneous results.

12. Built-In Control Feature

The control line serves as a built-in internal control and gives confirmation of sample addition and proper test 

performance. A pink/purple line will appear in the CONTROL (C) area if the test has been performed correctly and 

the device is working properly (Please see: Interpretation of Test Results). If the DPP Micro Reader does not detect 

a line in the CONTROL (C) area, then it will display “INV”, indicating that the test is INVALID.

INVALID (INV)

An INVALID test cannot be interpreted. It is recommended that the 

INVALID test be repeated with a new Test Device. If results are still 

invalid collect a fresh sample or test by another method.

INV
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13. External Quality Control

The DPP Ebola Rapid Test Control Pack (Catalog #:60-9554-0) is available separately for use with the DPP Ebola 

Antigen System. The controls are used to verify the operator’s ability to properly perform the test and to interpret 

the results. The DPP Ebola Reactive Control will produce a reactive test result and has been manufactured to 

produce a faint line in the TEST (T) area. The DPP Ebola Non-Reactive Control will produce a non-reactive test 

result. Run the controls as described in the Test Procedure section for a plasma sample and follow the directions in 

the Interpretation of Test Results section of this product insert. It is the responsibility of each facility using the 

DPP® Ebola Antigen System to establish an adequate quality assurance program to ensure the performance of the 

device under specific locations and conditions of use.

RUN THE KIT CONTROLS UNDER THE FOLLOWING CIRCUMSTANCES:

• Each new operator prior to performing tests on patient samples

• When opening a new test kit lot

• Whenever a new shipment of test kits is received

• If the temperature of the test storage area falls outside of 2 to 30 °C (36 to 86 °F)

• If the temperature of the testing area falls outside of 18 to 30 °C (64 to 86 °F)

• At periodic intervals as indicated by the user facility

If the Ebola Control reagents do not produce the expected results, contact Chembio Diagnostic Customer Service 

at 1-631-924-1135.

14. Conditions For Authorization For Laboratories and Facilities

The DPP® Ebola Antigen System Letter of Authorization, along with the authorized Fact Sheet for Healthcare 

Providers, the authorized Fact Sheet for Patients and authorized labeling are available on the FDA website: 

https://www.fda.gov/MedicalDevices/Safety/EmergencySituations/ucm161496.htm. Use of the DPP Ebola Antigen 

System must follow the procedures outlined in these manufacturer’s Instructions for Use and the conditions of 

authorization outlined in the Letter of Authorization. Deviations from the procedures outlined are not permitted 

under the Emergency Use Authorization. To assist clinical laboratories and facilities running the DPP Ebola Antigen 

System, the relevant Conditions of Authorization are listed verbatim below.

• Authorized laboratories and facilities will include with reports of the results of the DPP Ebola Antigen 

System the authorized Fact Sheet for Healthcare Providers and the authorized Fact Sheet for 

Patients. Under exigent circumstances, other appropriate methods for disseminating these Fact Sheets 

may be used, which may include mass media.

• Authorized laboratories and facilities will perform the DPP Ebola Antigen System as outlined in the DPP 

Ebola Antigen System Instructions for Use. Deviations from the authorized procedures, including the 

authorized instruments, authorized clinical specimen types, authorized control materials, authorized 

other ancillary reagents and authorized materials required to perform the DPP Ebola Antigen System are 

not permitted.

• Authorized laboratories and facilities must read the results of the DPP Ebola Antigen System on the DPP 

Micro Reader or on other authorized instruments. Authorized laboratories and facilities must not attempt 

to interpret the results of the DPP Ebola Antigen System visually.
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• Authorized laboratories and facilities will have a process in place for reporting test results to healthcare 

providers and relevant public health authorities, as appropriate.[1]

• Authorized laboratories and facilities will collect information on the performance of the DPP Ebola 

Antigen System and report to DMD/OIR/CDRH (via email CDRH-EUA-Reporting@fda.hhs.gov) and 

Chembio any suspected occurrence of false negative and false positive results and significant deviations 

from the established performance characteristics of which they become aware.

• All personnel using the assay must be appropriately trained in performing and interpreting 

immunochromatographic techniques, use appropriate laboratory and personal protective equipment 

when handling this kit, and use the test in accordance with the authorized labeling. All personnel using 

the assay must also be trained in and be familiar with the interpretation of results of the DPP Ebola 

Antigen System. 

• Chembio, its authorized distributor(s), and authorized laboratories and facilities will ensure that any 

records associated with this EUA are maintained until notified by FDA. Such records will be made 

available to FDA for inspection upon request.

15. Performance Characteristics

Analytical testing of the DPP Ebola Antigen System was conducted in BSL-4 (Center for Disease Control and 

Prevention, Atlanta, Georgia, USA) and BSL-2 (Chembio Diagnostic Laboratories, Medford, NY, USA) laboratories in 

2015.

Analytical Sensitivity/ Limit of Detection (LoD)

A Limit of Detection (LoD) range finding study in venous whole blood identified 9.88 x 105 TCID50/ mL as the 

tentative LoD for Ebola Inactivated Virus [Gamma irradiated Ebola virus from a West African isolate Ebola virus 

Makona strain variant 2014 (Spec.no. 812572, Liberia, 2014)]. The LoD was confirmed to be 1.23 x 105 TCID50/ mL 

in EDTA Whole Blood by all 20 replicates testing positive with the same Ebola Inactivated Virus at this 

concentration. In EDTA Plasma, the LoD was confirmed to be 2.47 x 105 TCID50/ mL by all 20 replicates testing 

positive with the same Ebola Inactivated Virus at this concentration.

Additionally, a LoD range finding study was performed using recombinant VP40 antigen spiked into EDTA venous 

whole blood and EDTA plasma. The LoD of the DPP Ebola Antigen System in EDTA plasma and EDTA venous whole 

blood with recombinant VP40 antigen was determined to be 250 ng/ mL or 12.5 ng/test. The LoD of the DPP Ebola 

Antigen System in serum with recombinant VP40 antigen was determined to be 150 ng/ mL or 7.5 ng/test.

LoD for the CDC inactivated Ebola virus slurry SPR582 was determined to be 1:128 in EDTA Whole Blood and EDTA 

Plasma and 1:256 in serum.

Table 1: Summary Table Comparing the Final LoD Determined in All Matrices Claimed for the DPP Ebola Antigen 

System for the Inactivated Ebola Virus Makona Strain Variant 2014 (Spec.no. 812572, Liberia, 2014), rVP40, and 

Ebola Virus Slurry SPR582

Matrix

Final LoD

Inactivated Ebola Virus 

Makona Strain (812572: rVP40 Ebola Virus Slurry SPR582

 

[1] According to CDC, EVD is a nationally notifiable condition (see https://www.cdc.gov/vhf/ebola/index.html).
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Liberia, 2014)

(TCID50/ mL)

EDTA Plasma 1:64

(2.47 x 105)

250 ng/ mL

or 12.5 ng/test

1:128

EDTA Whole Blood 1:128

(1.23 x 105)

250 ng/ mL

or 12.5 ng/test

1:128

Serum* N/A 150 ng/ mL

or 7.5 ng/test

1:256

N/A: Not Available

* Serum LoD studies are provided only to support some of the cross-reactivity studies

Field Samples

The clinical performance of the DPP® Ebola Antigen System was assessed in three separate studies using 

retrospective samples. In the first study conducted with thirty (30) frozen archived natural EDTA plasma samples

collected in Liberia, the overall Positive Percent Agreement against the comparator (CDC Ebola Virus VP40 Realtime RT-PCR Assay) was 85.0% (17/20) with 95% CI 64.0 –94.8%. The Negative Percent Agreement was 90.0% 

(9/10) with 95% CI 59.6% - 98.2% (Table 2).

Table 2: Percent Positive Agreement for select CT Value Ranges

PCR CT Value Ranges Percent Agreement 95% CI*

Negative 90.0% (9/10) 59.6%-98.2%

15-25 100.0% (9/9) 70.1-100.0%

15-30 82.4% (14/17) 59.0-93.8%

15-34 85.0% (17/20) 64.0-94.8%

* Calculated using score method

Table 3: DPP Ebola Antigen System & Comparator Results Stratified by CT Value Ranges

Comparator RT-PCR Results Comparator RTPCR Results

15- 20 21-<25 ≥25-<30 ≥30-34 Overall Ebola 

not detected

+ - + - + - + - + - + -

DPP

Ebola 

Results

+ 4 0 5 0 5 0 3 0 17 0 0 1

- 0 0 0 0 3 0 0 0 3 0 0 9

In the second study, the performance of the DPP Ebola Antigen System was evaluated using a blinded panel 

comprised of 100 EDTA plasma samples. The panel consisted of 50 negative frozen archived EDTA plasma samples 

from individuals from West Africa collected from 2001 to 2006, prior to the 2014 Ebola Outbreak, and 50 individual 

negative frozen EDTA plasma samples from individuals from Colombia with symptoms of febrile illness that also 

tested IgM positive for Dengue fever and IgG positive for Chikungunya. Samples were tested once and read in a 

blinded fashion by one operator with the DPP Micro reader. Fifty (50) individual samples (from Africa) were tested 

neat as negative samples on the DPP Ebola Antigen Assay. Twenty-five (25) of the febrile samples were tested after 

being spiked with the inactivated Ebola virus Makona strain variant 2014 (Spec.no. 812572, Liberia, 2014) at the 

Limit of Detection (LoD; i.e. 1:64) into clinical matrix, and the remaining 25 contrived febrile samples were tested 

after being spiked with the inactivated Ebola virus Makona strain variant 2014 at serial dilutions above and below 

the LoD. Of the 50 positive samples, 10 were below the detectable limit of the Assay (1:64). None of these samples 

were detected by the assay. The DPP Ebola Antigen System found 49 negative samples non-reactive (49/50 = 

98.0% with 95% CI extending from 89.5 to 99.7%). Of the 40 positive samples within the detectable limits of the 
17-4030-0 Rev 2

March 2019

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assay, the DPP Ebola Antigen System found 37 out of 40 to be reactive: 37/40 = 92.5% with 95% CI extending from 

80.1 to 97.4%. See Table 4.

Table 4: EDTA Plasma-Blinded Panel in Relation to LoD of Assay

DPP Ebola Antigen System Percent 95% CI*

Negative 98.0% (49/50) 89.5 – 99.7%

Percent positive above LoD 100.0% (15/15) 79.6% - 100.0%

Percent positive at LoD 88.0% (22/25) 70.1 % - 95.8%

* Calculated using the score method

A third study was conducted with a blinded panel of 100 EDTA whole blood samples. The panel consisted of 100 

individual negative EDTA whole blood samples from individuals from Africa with fever symptoms that also tested 

positive for malaria and in some cases specifically P.falciparum. Fifty (50) individual samples were tested neat as 

negative samples on the DPP Ebola Antigen Assay. Twenty (20) of the samples were tested after first being 

prepared by spiking the inactivated Ebola Virus (Ebola Slurry; Lot SPR852) at what at the time was thought to be 

the Limit of Detection (LoD; i.e. 1:256) into clinical matrix, and the remaining 30 contrived samples were tested 

after first being prepared by spiking the inactivated Ebola Virus at serial dilutions above and below the LoD (i.e 

1:16; 1:32; 1:64; 1:128; 1:512 with n=5 for each). After completion of the study, it was discovered that the LoD of 

inactivated Ebola Virus (Ebola Slurry; Lot SPR852) in EDTA Whole Blood was at the one-fold higher concentration of 

1:128. 

The DPP Ebola Antigen System identified 49 of the 50 negative whole samples to be non-reactive (49/50 = 98.0% 

with 95% CI extending from 89. 5 to 99.7%). Of the 20 positive samples within the detectable limits of the assay

(LoD of 1:128 and above), the DPP Ebola Antigen System found 20 out of 20 to be reactive: 20/20 = 100% with 95% 

CI extending from 83.9 to 100.0%). Thirty of the positive samples were below the limit of detection, with 23/30 

(76.7% CI extending from 59.1 to 88.2%) detected by DPP. See Table 5.

Table 5: EDTA Whole Blood Clinical Performance in relation to LoD of Assay1

DPP Ebola Antigen System Percent 95% CI*

Negative 98% (49/50) 89.5 to 99.7 %

Percent positive above LoD 100% (15/15) 79.62% - 100.0%

Percent positive at LoD 100% (5/5) 56.56 to 99.3 %

* Calculated using score method 1 These results were read at 20 minutes after addition of buffer to Well 2, which is outside the normal range of the assay time reading. 

However, the average values obtained were similar to those measured on time at similar dilutions.

High-Dose Hook Effect

Studies were conducted to evaluate if a hook effect occurs for the DPP Ebola Antigen System by testing increasing 

purified recombinant VP40 antigen concentrations in serum from 0 ng/ mL up to 0.1 mg/ mL This concentration 

range is based on LoD studies on the DPP® Ebola Antigen System where the assay was found to have a confirmed 

LoD of 250 ng/ mL or 12.5 ng/ test and measurement of virus load in clinical specimens by Q-RT-PCR assay and 

plaque assay4

. There was no decrease in the test line intensity by the reader for a VP40 antigen concentration from 

0 to 400 times the established LoD. This demonstrates that the DPP® Ebola Antigen System does not generate 

High-dose Hook or Prozone effect within the range of the assay. 

Clinical Specificity

The clinical specificity of the DPP Ebola Antigen System with samples negative for Ebola virus species and strains 

was assessed by testing two-hundred and thirty-eight (238) plasma samples and two-hundred and fifty (250) whole 

blood samples over a series of experiments. All samples were collected from asymptomatic individuals from an 

area non-endemic for Ebola. In brief, for EDTA plasma specimens the clinical specificity was found to be 98.7% 
17-4030-0 Rev 2

March 2019

Page 15 of 21

(235/238 = 98.7% with 95% CI from 96.4 to 99.6%). For EDTA whole blood the clinical specificity was found to be 

98.2% (245.5/250 = 98.2% with 95% CI 95.7 to 99.3%).

To support a fingerstick whole blood claim, a specificity study was carried out by testing fingerstick whole blood 

specimens collected from fifty-five (55) asymptomatic U.S. volunteers on the DPP Ebola Antigen System. Fifty-four 

(54) of the 55 fingerstick whole blood specimens tested in this study were negative; one specimen generated a 

trace signal, resulting in a percent negative agreement against the expected negative results of 54/55= 98.2% (95% 

CI 90.4 to 99.7 %).

A summary of the clinical specificity of the DPP® Ebola Antigen System can be found in Table 6 below. 

Table 6: Clinical Specificity of the DPP Ebola Antigen System

Matrix Percent 95% CI*

EDTA plasma 98.7% (235/238) 96.4 to 99.6%

EDTA venous whole blood 98.2% (245.5/250) 95.7 to 99.3%

Fingerstick (capillary) blood 98.2% (54/55) 90.4 to 99.7 %

* Calculated using score method

^ Measured with opTricon opTrilyzer, conversion factor used to obtain the Micro Reader values.

Cross Reactivity

Cross-reactivity of the DPP Ebola Antigen System was evaluated by testing additional viral, bacterial, or parasitic 

pathogens. In one study three (3) replicates were tested with the pathogens spiked into serum (Tables 7, 8, and 9) 

and three (3) or 20 replicates were tested in whole blood (Tables 10 and 11) at the concentrations listed in the 

tables below. P. ovale, showed cross-reactivity in serum in concentrations of 2.41 x 104 parasites/uL. Crossreactivity was observed in a single specimen of Plasmodium malariae tested at 1.3 x 104 and 7 x 103 parasites/ uL

in serum and whole blood respectively. Other two specimens with the highest and the lowest concentrations of 

Plasmodium malariae tested negative in whole blood.
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Table 7: Cross-Reactant Testing (where # reactive/# tested)

Organism Strain Format tested Testing 

Concentration

Organism + 

Negative Serum 

+ Saline

Organism + 

Negative

Serum

Organism + 

Negative Serum + 

rVP40

(500 ng/ mL) in 

Saline

Adenovirus Type 5 Heat-inactivated 1.51 x106 TCID50/ mL 0/3 0/3 3/3

Chikungunya R80422 Heat-inactivated 2.82 x107 TCID50/ mL 0/3 0/3 3/3

Dengue Virus-Serotype 1 Hawaii Heat-inactivated 7.24 x105 TCID50/ mL 0/3 0/3 3/3

Dengue Virus-Serotype 2 New Guinea C Heat-inactivated 1.05 x106 TCID50/ mL 0/3 0/3 3/3

Dengue Virus-Serotype 3 H87 Heat-inactivated 2.09 x106 TCID50/ mL 0/3 0/3 3/3

Dengue Virus-Serotype 4 H241 Heat-inactivated 1.26 x106 TCID50/ mL 0/3 0/3 3/3

Enterovirus Type 68 (2007 

Isolate)

Heat-inactivated 1.95 x107 TCID50/ mL 0/3 0/3 3/3

HIV-1 (Subtype B) IIIB Heat-inactivated 3.39 x107 TCID50/ mL 0/3 0/3 3/3

HIV-1 (Subtype O) Subtype O Live virus 9.35 x106 TCID50/ mL 0/3 0/3 3/3

HIV2 NIH-Z Heat-inactivated 2.19 x106 TCID50/ mL 0/3 0/3 3/3

Hepatitis B N/A Live virus 1.08 x109 mLU/ mL 0/3 0/3 3/3

Hepatitis C N/A Live virus 6.05 x106 mIU/ mL 0/3 0/3 3/3

Influenza virus A A/New 

Cal/20/99/H1N1

Heat-inactivated 4.57 x106 TCID50/ mL 0/3 0/3 3/3

Influenza virus B B/Florida/04/2006 Heat-inactivated 4.57 x106 TCID50/ mL 0/3 0/3 3/3

Rotavirus WA Heat-inactivated 1.15 x107 TCID50/ mL 0/3 0/3 3/3

RSV A 2006 Isolate Heat-inactivated 3.16 x106 TCID50/ mL 0/3 0/3 3/3

Yellow Fever 17D Heat-inactivated 1.26 x106 TCID50/ mL 0/3 0/3 3/3

Yersinia Pestis Colorado 92 Heat-inactivated 3.01 x109 CFU/ mL 0/3 0/3 3/3

Yersinia Pestis1 A1122 Live virus 2.2 x108 CFU/ mL 0/3 0/3 3/3

Yersinia enterocolitica Z036 Live 5.8 x 107 CFU/ mL 0/3 0/3 3/3 1 Yersinia Pestis strain A1122 was spiked with recombinant Ebola VP40 protein at a final concentration of 300 ng/ mL as this cross-reactant alone was conducted separately. 
17-4030-0 Rev 2

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Table 8: Cross-Reactant Testing (where # reactive/# tested)

Organism Strain Format 

tested

Testing Concentration Organism + 

Negative Serum + 

Saline

Organism + 

Negative

Serum

Organism + Negative 

Serum + rVP40

(500 ng/ mL) in Saline

Salmonella enterica Tryphimurium Live 1.19 x1010 CFU/ mL 0/3 0/3 3/3

Salmonella typhi Zi52 Live 1.89 x109 CFU/ mL 0/3 0/3 3/3

Shigella sonnei Z004 Live 2.29 x109 CFU/ mL 0/3 0/3 3/3

Pseudomonas aeruginosa Clinical isolate Live 3.93 x109 CFU/ mL 0/3 0/3 3/3

Vibrio cholera Z132 toxigenic Live 1.8 x1010 CFU/ mL 0/3 0/3 3/3

Haemophilus influenzae B Eagan Live 7.6 x108 CFU/ mL 0/3 0/3 3/3

Neisseria meningitidis Serogroup A Live 7.07 x108 CFU/ mL 0/3 0/3 3/3

Table 9: Cross-Reactant Testing (where # reactive/# tested)

Organism Strain Format tested Testing Concentration Organism + 

Negative Serum + 

Saline

Organism + 

Negative

Serum

Organism + Negative 

Serum + rVP40

(750 ng/ mL) in Saline

Plasmodium Vivax Live See note below± 0/3 0/3 3/3

Falciparum Live Unknown* 0/3 0/3 3/3

Ovale Live 2.41 x104 parasites/ uL 0/3 1/3 3/3

Malariae Live 1.3 x104 parasites/ uL± 0/3 1/3 3/3

Trypanosoma cruzi Live See note below^ 0/3 0/3 3/3

* EDTA Whole blood patient sample collected in Cameroon tested positive for Malaria on the BIOCREDIT Rapid Test Malaria Ag Pf (HRP II) 

± On Abcam Malaria IgG/M, Sample had OD value 1.184 with index of 2.812. Positive for Malaria SD BIOLINE Malaria Ag P.f/ Pv test with visual value of 3. Patient had symptoms of fever, headache, 

nausea and vomiting 

^ On Wiener Laboratories Chagas test ELISA, Sample had OD value was 1.68 
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Table 10: Cross-Reactant Testing in EDTA Whole Blood, 

300 ng VP40 

in Saline

300 ng VP40 in

Whole Blood

Plasmodium malariae

in whole blood

Plasmodium malariae

in whole blood + saline

Plasmodium malariae

in whole blood

+ 300 ng VP40 in Saline

NT 3/3= 100% R

Estimated Testing 

Concentration

5.8 x104 parasites/ uL

Estimated Testing 

Concentration

5.8 x104 parasites/ uL

Estimated Testing 

Concentration

5.8 x104 parasites/ uL

0/20=0% R NT 20/20=100% R

20/20=100% R NT

Estimated Testing 

Concentration

7.0 x103 parasites/ uL1

Estimated Testing 

Concentration

7.0 x103 parasites/ uL1

Estimated Testing 

Concentration

7.0 x103 parasites/ uL1

1/20=5% R 2/20=10% R 20/20=100% R

NT NT

Estimated Testing 

Concentration

1.8 x103 parasites/ uL

Estimated Testing 

Concentration

1.8 x103 parasites/ uL

NT

 Estimated Testing 

Concentration

1.8 x103 parasites/ uL

0/20=0% R 20/20=100% R

300 ng VP40 

in Saline

300 ng VP40 in 

Whole Blood

S. pneumoniae

in Whole Blood2

S. pneumoniae

in Whole Blood2 + 

saline

S. pneumoniae 

in Whole Blood2 + 

300ng/mL VP40

3/3= 100% R 3/3= 100% R 0/20=0% R NT 20/20=100% R

R = Reactive; NT=Not Tested 1 Based on original material having a parasite level of 2.8 x 104 parasite/ uL. The material used for this study contained dead malaria parasites 

and was diluted 4-fold. 2

No concentration available.

Table 11: Cross-Reactant Testing (where # reactive/# tested)

Organism Titer Organism + 

Negative 

Whole Blood + 

Saline

Organism + 

Negative 

Whole 

Blood

Organism + Negative Whole Blood + 

Inactivated Ebola Virus Makona Strain 

Variant 2014 (Liberia, 2014) (1:64) in 

Saline

Ebola 

Bundibugyo

5x106 TCID50/mL 0/3 0/3 3/3

Ebola Ivory 

Coast

N/A 0/3 0/3 3/3

Ebola Reston 1x107.5 pfu/ mL 0/3 0/3 3/3

Ebola Sudan 

Gulu

5.6x105 pfu/mL 0/3 0/3 3/3

Ebola Sudan 

Boniface

1x106 pfu/ mL 0/3 0/3 3/3

Marburg 

Angola

N/A 0/3 0/3 3/3

Marburg 

Musoke

1x107.5 pfu/ mL 0/3 0/3 3/3

Marburg Ravn 2.85x106 TCID 50// 0/3 0/3 3/3
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mL

Marburg 

Voege

3.6 x 107 pfu/ mL 0/3 0/3 3/3

Interfering Substances

Controlled studies of potentially interfering substances were performed on negative and positive whole blood

samples near the clinical decision points. Testing was performed as per CLSI guidelines EP7-A2 and EP37. 

Rheumatoid Factor showed interference on the DPP Ebola Antigen System at concentrations above 125 IU/mL. No 

interference was seen at the testing concentrations listed below.

Table 12: Interfering Substances for the DPP Ebola Antigen System in Whole Blood

(where # reactive/# tested)

Interferent Testing 

Concentration

Interferent + Negative 

Whole Blood + Saline

Interferent + 

Negative Whole 

Blood

Interferent + Negative 

Whole Blood + rVP40 (300 

ng/mL) in Saline

Serum proteins 11 g/ dL or 

110 mg/ mL 0/3 0/3 3/3

HAMA 663 ng/mL 0/3 0/3 3/3

Rheumatoid Factor 125 IU/ mL 0/5 0/5 5/5

Bilirubin conjugated 0.4 mg/ mL 0/3 0/3 3/3

Bilirubin 

unconjugated 0.4 mg/ mL 0/3 0/3 3/3

Cholesterol 4 mg/mL 0/3 0/3 3/3

Glucose 10 mg/mL 0/20 0/20 20/20

Hemoglobin 10 mg/ mL 0/3 0/3 3/3

Reading Reproducibility Study 

The reproducibility of reading the DPP Ebola Antigen System was evaluated using blinded EDTA venous whole 

blood samples and blinded EDTA plasma samples spiked with various levels of inactivated Ebola Virus slurry. A 

total of 300 measurements per sample matrix were obtained. The calculated reproducibility of the DPP Ebola 

Antigen System was 94.3% (283/300 = 94.3% with 95% CI 91.1 to 96.4%) for EDTA whole blood and 93.0% 

(279/300 = 93.0% with 95% CI 89.5 to 95.3%) for EDTA plasma.

WHO International Reference Panel for Ebola virus VP40 antigen

In support of the World Health Organization’s (WHO) ongoing activities related to Ebola virus, The National 

Institute for Biological Standards Control (NIBSC) conducted an international collaborative study to develop a 

standardized Ebola virus VP40 protein preparation to serve as WHO International Reference Reagents (IRR) for use 

in monitoring the performance of POC tests for the detection of VP40. Chembio Diagnostic Systems was invited to 

participate and provided kits of the DPP Ebola Antigen System for assessment as part of this study. 

Nine study samples were formulated by dilution in a pool of thrombinized and declotted plasma screened negative 

for HBsAg, anti-HIV and anti-HCV. Three sets of nine samples were provided to Chembio freeze-dried, coded and 

blinded. The coded samples included both negative and positive samples. Directions for reconstitution of the 

freeze-dried materials were given in the instructions for use included with the study samples. Results using three 

lots total of the DPP Assay, one per panel set, are summarized in Table 13 below. 
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Table 13: Ebola VP40 in DPP Ebola Antigen System Results Using the WHO International Reference Panel

Sample #

1 2 3 4 5 6 7 8 9

VP 40

(high)

VP 40

(medium)

VP40

(medium)

VP40

(low)

VP40

(low)

VP 40

(high)

VP40-GP-NPsVLPs

(high)

Negative VP40-GPNPs-

(medium)

DPP Ebola, 

Lot 1 

292

(R)

168

(R)

69

(R)

98

(R)

17

(R)

167

(R)

194

(R)

7

(NR)

223

(R)

DPP Ebola,

Lot 2 

298

(R)

195

(R)

109

(R)

107

(R)

22

(R)

166

(R)

194

(R)

6

(NR)

220

(R)

DPP Ebola,

Lot 3 

300

(R)

226

(R)

114

(R)

107

(R)

25

(R)

162

(R)

194

(R)

6

(NR)

207

(R)

NR = Non-Reactive; R = Reactive

Notes: # High, medium, and low indicate the relative amounts antigen present as assessed during formulation of the study samples. 

In a separate LoD determination study, three vials of sample 3 from the WHO Ebola QC Material (as described 

above) were obtained from WHO/NIBSC. After reconstitution with distilled water, the samples were pooled. From 

the pool, sample was prepared and tested as the undiluted material plus serial dilutions at 1:3, 1:6, 1: 9, 1:12, 1:24, 

and 1:48 (diluted in EDTA whole blood) on the DPP Ebola Antigen System. For all dilutions, five independent 

replicates (not five samplings from a single series) were prepared and assayed. Due to volume limitations, the 

undiluted material was only tested in duplicate. As can be seen from the results below (Table 14), the EDTA whole 

blood used as diluent before spiking sample 3 gave a negative result on the DPP Ebola Antigen System (3 

replicates). The last dilution at which no signal is detected by the DPP Ebola Antigen System is 1:48. At the 1:9 

dilution, 5 of 5 replicates were reactive. At the 1:12 dilution, 4 of the 5 replicates were reactive. There was not 

enough material to ascertain if further independent replicates at the 1:12 dilution would continue to be reactive 

on the DPP Assay.

Table 14. Serial Dilutions of WHO Ebola QC Material Sample 3 on the DPP Ebola Antigen System. 

DPP Ebola Antigen System

Negative Blood Rep 1 Rep 2 Rep 3

10 8 10

WHO Panel CS 571, Member 3, DPP Ebola Antigen System

Rep 1 Rep 2 Rep 3 Rep 4 Rep 5

Undiluted 0 ND 81 (R) ND ND 54 (R) 

Dilution 1:3 36 (R) 35 (R) 27 (R) 23 (R) 22 (R) 

1:6 17 (R) 14 (R) 21 (R) 12 (R) 21 (R) 

1:9 15 (R) 18 (R) 13 (R) 12 (R) 12 (R) 

1:12 8.5 (NR) 17 (R) 16 (R) 14 (R) 13 (R) 

1:24 11 (NR) 14 (R) 10 (NR) 10 (NR) 10 (NR) 

1:48 7.6 (NR) 10 (NR) 8.3 (NR) 8.1 (NR) 8.5 (NR)

ND= Not Done; NR = Non-Reactive; R = Reactive

Due to volume limitations, the undiluted sample was only tested in duplicate.

16. References
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1. CDC’s 2014 Guideline for Isolation Precautions: Preventing Transmission of Infectious Agents in 

Healthcare Setting Available from: http://www.cdc.gov/vhf/ebola/hcp/infection-prevention-and-controlrecommendations.htmL

2. August 1, 2014 CDC released guidance titled, ”Infection Prevention and Control Recommendations for 

Hospitalized Patients with Known or Suspected Ebola Hemorrhagic Fever in U.S. Hospitals.” Available 

from: http://www.cdc.gov/vhf/ebola/hcp/infection-prevention-and-control-recommendations.htmL

3. Centers for Disease Control and Prevention, How U.S. Clinical Laboratories Can Safely Manage Specimens 

from Persons Under Investigation for Ebola Virus Disease Available from: 

http://www.cdc.gov/vhf/ebola/hcp/safe-specimen-management.htmL

4. Towner JS, Rollin PE, Bausch DG, Sanchez A, Crary SM, Vincent M, Lee WF, Spiropoulou CF, Ksiazek TG, 

Lukwiya M, Kaducu F, Downing R, Nichol ST, Lee WF, Nichol ST. 2004. Rapid diagnosis of Ebola 

hemorrhagic fever by reverse transcription-PCR in an outbreak setting and assessment of patient viral 

load as a predictor of outcome. J Virol 78:4330–4341.

5. CLSI. Evaluation of Detection Capability for Clinical Laboratory Measurement Procedures; Approved 

Guideline – Second Edition. CLSI Document EP17-A2. Wayne, PA: Clinical and Laboratory Standards 

Institute; 2012.

ORDERING INFORMATION

61-1013-0 Chembio DPP® Ebola Antigen

System

61-1050-0 Chembio DPP® Micro Reader

60-9554-0 Chembio DPP® Ebola Rapid Test

Control Pack

For Product Information, Literature and/or SDS please 

email info@chembio.com

 CHEMBIO DIAGNOSTIC SYSTEMS, INC.

3661 HORSEBLOCK ROAD

MEDFORD, NY 11763 USA

Tel: 1-844-CHEMBIO (844-243-6246)

Email: info@chembio.com

Web Site: www.chembio.com

SYMBOL LEGEND

CONSULT THE MANUAL BEFORE USE

CAUTION, CONSULT THE ACCOMPANYING 

DOCUMENTS

DO NOT RE-USE

FOR USE WITHIN TEMPERATURE LIMITS

IN VITRO DIAGNOSTIC MEDICAL DEVICE

BATCH CODE

PRODUCT CATALOG NUMBER

MANUFACTURERS IDENTIFICATION

Rx 

Only PRESCRIPTION DEVICE

USE BY DATE

CONTAINS SUFFICIENT FOR 20 TESTS
 

 

For use under the Emergency Use Authorization (EUA) only | For prescription use only | For In Vitro diagnostic Use Only 

DPP® Ebola Antigen System: Quick Reference Instructions Cat No. 61-1013-0 

Before you begin 

These instructions are only a Reference Guide. Read the complete DPP® Ebola Antigen System 

Product Instructions and the DPP® Micro Reader User Manual before performing the test. 

• Gather the material you will need. 

• Cover your work station with a clean, disposable absorbent workplace cover. 

• Wear disposable gloves, gown (fuid resistant or impermeable), and eye protection (goggles or 

face shield). 

• Let the test reach room temperature (between 8-30°C or 64-86°F) before opening the pouch. 

For problems or questions, 

please contact: 

Chembio Diagnostic Systems 

Customer Services - 

844-CHEMBIO (243-6246) 

Materials included 

• 20 DPP® Ebola Antigen Individually Pouched 

Test Devices 

• 20 Microsafe Tubes (50uL) 

• 20 Sterile Safety Lancets (for fngerstick

 whole blood samples) 

• 20 Adhesive Bandages 

• 20 Sterile Alcohol Swabs 

•

 with GREEN Cap 

• 1 Product Insert 

• 1 Quick Reference Instructions 

• 1 Fact Sheet for Healthcare Providers 

• 1 Fact Sheet for Patients 

Materials required but not included 

• DPP® Ebola Rapid Test Control Pack (Catalog #60-9554-0) 

• Clock, watch or other timing device 

• Disposable gloves 

• Sterile gauze (for fngerstick samples only) 

• Biohazard disposal containers 

• Pipettor capable of delivering 20-200μL of sample (for other than fngerstick

 specimens) 

• Pipette tips 

• DPP® Micro Reader (Catalog #61-1050-0) 

Each kit contains: 

• 1 DPP® Micro Reader with Ebola RFID sticker (includes 3 batteries) 

• 1 DPP® Cartridge Holder for use with DPP® Test Device 

• 1 USB adapter (will only transmit power) 

• 1 Power plug adapter 

• 1 Microfber Cloth 

• 1 User Manual for the DPP® Micro Reader 
DPP ® Ebola Antigen System: Quick Reference Instructions For In Vitro diagnostic use 

1 2 

3 4 5 

COLLECTION: FINGERSTICK WHOLE BLOOD 

Collect 50μL of Sample by holding Microsafe® Tube horizontally. Ensure Tube 

is flled to the black line. DO NOT squeeze the bulb at the top of the tube. 

Capillary action will draw the sample to the black fll line. 

The blue colored line should 

have disappeared. If not, DO 

NOT USE, discard test 

device and use a new Test 

Device. 

Add 6 drops of DPP® Ebola 

Antigen System Buffer 

(Green Cap) slowly, dropwise, 

into BUFFER Well 2. 

Read results 10-15 min 

AFTER addition of 

SAMPLE + BUFFER DELIVERY INTO WELL 1 

Holding the Microsafe® Tube vertically 

over the SAMPLE+BUFFER Well 1, 

squeeze the bulb to release 50μL 

sample into the well. 

Immediately add 3 drops of 

DPP® Ebola Antigen System Buffer 

(Green Cap) into Well 1. 

WAIT 

5 

MINUTES 

RUNNING BUFFER DELIVERY INTO WELL 2 RESULTS INTERPRETATION 

The Chembio DPP® Micro Reader must be used for all 

interpretation of test results. Do not attempt to interpret 

the results visually. 

A PINK fow should begin across 

the strip within 2-3 minutes of 

. If NO PINK fow is 

present, repeat with a new device. 

DO NOT ATTEMPT TO INTERPRET RESULTS VISUALLY. ALWAYS USE THE DPP® MICRO READER TO OBTAIN RESULTS. 

A Reactive test result means 

that Ebola antigen has been 

detected in the specimen. 

REACTIVE NONREACTIVE 

A non-reactive test result 

means that Ebola antigen 

was not detected in the 

specimen. 

An INVALID test cannot be 

interpreted. 

INVALID 

EVD + A Reactive test result means EVD - INV 

that Ebola antigen has been 

detected in the specimen. 

REACTIVE NONREACTIVE 

A non-reactive test result 

means that Ebola antigen 

was not detected in the 

specimen. 

An INVALID test cannot be 

interpreted. 

INVALID 

EVD + EVD - INV 
DPP ® Ebola Antigen System: Quick Reference Instructions For In Vitro diagnostic use 

1 COLLECTION: VENOUS BLOOD/PLASMA 2

Using a calibrated pipette, collect 50μL of Sample. 

SAMPLE + BUFFER DELIVERY INTO WELL 1 

Using a calibrated pipette, add 50μL 

of the sample to SAMPLE + BUFFER 

Well 1. 

Immediately add 3 drops of 

DPP® Ebola Antigen System Buffer 

(Green Cap) into Well 1. 

3 4 5 

The blue colored line should 

have disappeared. If not, DO 

NOT USE, discard test 

device and use a new Test 

Device. 

Add 6 drops of DPP® Ebola 

Antigen System Buffer 

(Green Cap) slowly, dropwise, 

into BUFFER Well 2. 

Read results 10-15 min 

AFTER addition of 

WAIT 

5 

MINUTES 

RUNNING BUFFER DELIVERY INTO WELL 2 RESULTS INTERPRETATION 

The Chembio DPP® Micro Reader must be used for all 

interpretation of test results. Do not attempt to interpret 

the results visually. 

A PINK fow should begin across 

the strip within 2-3 minutes of 

. If NO PINK fow is 

present, repeat with a new device. 

DO NOT ATTEMPT TO INTERPRET RESULTS VISUALLY. ALWAYS USE THE DPP® MICRO READER TO OBTAIN RESULTS. 

A Reactive test result means 

that Ebola antigen has been 

detected in the specimen. 

REACTIVE NONREACTIVE 

A non-reactive test result 

means that Ebola antigen 

was not detected in the 

specimen. 

An INVALID test cannot be 

interpreted. 

INVALID 

EVD + EVD - INV 
DPP ® Ebola Antigen System: Quick Reference Instructions For In Vitro diagnostic use 

DO NOT ATTEMPT TO INTERPRET RESULTS VISUALLY. 

ALWAYS USE THE DPP®

Using the Chembio DPP® MICRO READER TO OBTAIN RESULTS. Micro Reader 

These instructions are only a Reference Guide. Read the complete User Manual before using the DPP® Micro Reader. 

A Ensure that the reader and components are clean. Remove any dust 

or debris. Connect the DPP® Micro Reader to the supplied cartridge 

holder as shown. 

DPP® Micro Cartridge Holder

B C Press the operating 

button again and the 

display will read “RFID”. 

The display will read 

“TEST”. 

At the time indicated for 

reading the test results, 

place the reader and 

holder onto the top of the 

cassette and push the 

operating button. “ON” 

should appear in the 

reading window. 

Reading 

Push this 

button 

Reader 

DPP® Micro 

Reader correctly 

seated in holder 

CORRECT Reader 

Placement 

INCORRECT 

Placement 

Reader is 

NOT seated 

properly 

window 

Press the operating button and “RUN” will appear in the 

display window. 

After approximately 3 seconds, a 

result for the DPP® Ebola test device 

will appear across the display 

NOTE: As soon as the test is complete, the user should manually 

record the result. 

approximately 50 seconds of inactivity. There is no active function to 

D 

CHEMBIO DIAGNOSTIC SYSTEMS, INC. 

Tel: (631) 924-1135 | Email: info@chembio.com | www.chembio.com 

E A Reactive test result means that Ebola antigen has 

been detected in the specimen. The patient is 

presumed Positive for Ebola antigen. Follow up 

testing with PCR to confrm test result. 

A non-reactive test result means that Ebola antigen 

was not detected in the specimen. The test result is 

interpreted as not having detected Ebola antigen. 

The patient is presumed Negative for Ebola antigen. 

An INVALID test cannot be interpreted. It is 

recommended that the INVALID test be repeated 

with a new device. 

EVD + 

EVD -

INV 

Ordering Cat No. Description 

Information: 61-1050-0 DPP® Micro Reader 
 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

For use under the Emergency Use Authorization only 60-9554-0 

DPP® Ebola Rapid Test Control Pack 

Chembio DPP Ebola Reactive Control and DPP Ebola Non-Reactive Control 

For in vitro diagnostic use 

For Prescription Use Only 

STORAGE: Store at 25 °C 

Read this Product Insert and the DPP® Ebola Antigen System 

Product Insert completely before using this product. Follow the 

instructions carefully when performing the test as not doing so 

may result in inaccurate Test Results. Users of this test MUST 

read and become familiar with Universal Precautions for 

prevention of transmission of blood borne pathogens in HealthCare Settings and the CDC’s guidance on how to safely manage 

specimens from persons under investigation for Ebola Virus 

Disease. [1] 

INTENDED USE 

The Chembio DPP Ebola Reactive control and DPP Ebola NonReactive Control are quality control reagents for use with the 

Chembio DPP Ebola Antigen System only. 

Run the Kit Controls under the following circumstances: 

• Each new operator prior to performing tests on patient 

specimens, 

• When opening a new test Kit lot, 

• Whenever a new shipment of test Kits is received, 

• If the temperature of the test storage area falls outside

of 2 to 30°C (36 to 86°F), 

• If the temperature of the testing area falls outside of 18 

to 30°C (64 to 86°F), 

• At periodic intervals as indicated by the user facility. 

It is the responsibility of each laboratory using the DPP Ebola 

Antigen System to establish an adequate quality assurance 

program to ensure the performance of the device under its 

specific locations and conditions of use. 

SUMMARY AND EXPLANATION OF EBOLA REACTIVE AND 

NONREACTIVE CONTROLS 

Chembio DPP Ebola Reactive control and DPP Ebola NonReactive Control are human, serum-based reagents. The 

Controls are specifically formulated and manufactured to ensure 

performance of the DPP® Ebola Antigen System test, and are 

used to verify the user’s ability to properly perform the test and 

interpret the results. The Chembio DPP Ebola Reactive Control 

will produce a REACTIVE (EVD+) Test Result and have been 

manufactured to produce a faint Test “T” line. The Chembio DPP 

Ebola Non-Reactive Control will produce a NONREACTIVE 

(EVD-) Test Result. Use of Control Reagents manufactured by 

another source may not produce the required results, and 

therefore, will not meet the requirements for an adequate quality 

assurance program for the Chembio DPP Ebola Antigen System. 

MATERIALS PROVIDED 

Each DPP Ebola Rapid Test Control Pack contains a Product 

Insert and two Vials (one DPP Ebola Reactive Control and one 

DPP Ebola Non-Reactive Control) as described. 

DPP Ebola Reactive Control 

One Vial containing 0.5mL of lyophilized heat inactivated 

Recombinant Ebola virus (species Zaire ebolavirus) VP40 protein 

(600 ng/ml) in normal human serum negative for HBsAg, HCV Ab, 

HIV 1/2 ag, HBV DNA, HCV RNA, HIV RNA, RPR (syphilis) and 

preservative (0.09% sodium azide). 

DPP Ebola Non-Reactive Control 

One Vial containing 0.5mL of lyophilized normal human serum 

negative for HBsAg, HCV Ab, HIV 1/2 ag, HBV DNA, HCV RNA, 

HIV RNA, RPR (syphilis) and preservative (0.09% sodium azide). 

MATERIALS REQUIRED AND PROVIDED 

in the Chembio DPP Ebola Antigen System (Cat# 61-1013-0) 

Each kit contains the items to perform 20 tests: 

• 20 DPP Ebola Antigen System Test Devices -

Individually Pouched 

• 20 Disposable Microsafe® Tubes (50μL) 

• 20 Sterile Safety Lancets (for fingerstick whole 

blood samples) 

• 20 Adhesive Bandages 

• 20 Sterile Alcohol Swabs 

• 1 DPP Ebola Antigen System Buffer (7mL) – 

Green Cap 

• 1 Product Insert 

• 1 Quick Reference Instructions 

• 1 Fact Sheet for Health Care Providers 

• 1 Fact Sheet for Patients 

ACCESSORIES THAT ARE AVAILABLE AND REQUIRED 

INCLUDE THE 

Chembio DPP Micro Reader (Catalog # 61-1050-0) 

Each kit contains: 

• 1 Chembio DPP Micro Reader with Ebola RFID sticker 

(includes 3 Lithium-ion, type CR2032 (3 V/230 mAh) 

coin cell batteries) 

• 1 DPP Cartridge Holder for use with DPP Ebola Antigen 

Test Device 

• 1 Custom Power Cable (USB) 

• 1 Power plug Adapter 

• 1 Microfiber Cloth 

• 1 User Manual for the DPP Micro Reader 

MATERIALS REQUIRED BUT NOT PROVIDED 

• Clock, watch or other timing device 

• Disposable gloves 

• Sterile gauze (for fingerstick samples only) 

• Collection devices (for venous whole blood or 

serum/plasma specimens) 

• Biohazard disposal containers 

• Pipettor capable of delivering 20-200μL 

• Pipette tips 

WARNINGS 

For IN VITRO diagnostic use 

1. Read this Product Insert and the DPP Chembio Ebola Antigen 

System Product Insert completely before using this product. 

Follow the instructions carefully as not doing so may result in 

inaccurate Test Results. 

2. Users of this test MUST read and become familiar with the 

CDC’s “Guideline for Isolation Precautions: Preventing 

Transmission of Infectious Agents in Healthcare Setting” [1], 

the CDC’s guidance on ”Infection Prevention and Control 

Recommendations for Hospitalized Patients with Known or 

Suspected Ebola Hemorrhagic Fever in U.S. Hospitals” [2], and 

the CDC’s guidance on “How U.S. Clinical Laboratories Can 

Safely Manage Specimens from Persons Under Investigation 

for Ebola Virus Disease” [3] 

3. Do not eat, drink or smoke in the area where specimens and kit 

reagents are handled. Avoid any contact with hands, eyes or 

mouth during specimen collection and testing. 

4. Put on disposable Gloves, Gown (fluid resistant or 

impermeable), Eye protection (goggles or face shield) and 

Facemask. Additional PPE might be required in certain 

10-6297-0 Rev 1 

Page 1 of 3 Nov 9, 2018 
 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

situations (e.g., copious amounts of blood, other body fluids, 

vomit, or feces present in the environment), including but not 

limited to: Double gloving, Disposable shoe covers and leg 

coverings. 

5. Dispose of all specimens and materials used in the test 

procedure in a biohazard waste container. Lancets should be 

placed in a puncture-resistant container prior to disposal. The 

recommended method of disposal of biohazard waste is 

autoclaving for a minimum of 1 hour at 121oC. Disposable 

materials may be incinerated. Liquid wastes may be mixed with 

appropriate chemical disinfectants. A freshly prepared solution 

of 10% bleach (0.5% solution of sodium hypochlorite) is 

recommended. Allow 60 minutes for effective decontamination. 

NOTE: Do not autoclave solutions that contain bleach. 

6. Use 10% bleach or other appropriate disinfectant to wipe all 

spills. The bleach solution should be made fresh each day. 

7. Use of Kit Control reagents manufactured by another source 

may not produce the required results, and therefore, will not 

meet the requirements for an adequate quality assurance 

program for the Chembio DPP Ebola Antigen Assay. 

STORAGE AND STABILITY 

The Chembio DPP Ebola Reactive Control and DPP Ebola NonReactive Control can be stored at 25 ± 5°C/ 77± 9°F if unopened. 

Once opened and rehydrated, these Ebola control reagents 

should be stored at 2 to 8°C (36 to 46°F) for no more than 30 

days. Do not use beyond the indicated expiration date on the vial. 

Open the Control Vials only when you are performing tests. 

Recap and store the Control Vials in their original container at 2 to 

8°C (36 to 46°F) after use. The test devices should be stored in 

its unopened pouch at 2 to 30°C (36 to 86°F). Do not freeze. Do 

not open the pouch until you are ready to perform a test. When 

stored as indicated, Test Devices are stable until the expiration 

date marked on the pouch. The Running Buffer (for Chembio DPP 

Ebola Antigen System) should also be stored at 2 to 30°C (36 to 

86°F) in its original Vial. 

TEST PROCEDURE 

All components for the Chembio DPP Ebola Antigen System are 

ready to use as supplied. Instructions for use are given in the 

Chembio DPP Ebola Antigen System Product Insert. Follow 

directions as indicated. If the specimen to be tested is 

refrigerated, remove it from the refrigerator and allow it to come to 

a temperature of 18 to 30°C (64 to 86°F) prior to testing. 

Procedure for Using Controls with Chembio DPP Ebola 

Antigen System 

First Use of Chembio DPP Ebola Reactive Control and DPP 

Ebola Non-Reactive Control 

1. Open a Control Vial containing the Control Reagent. 

2. Using a calibrated pipettor capable of delivering 100-

1000μL, add 500μL of deionized water to each of the 

Control Vials. 

3. Mix on a rocker for 15-20 min until material is in a solution. 

To Run Controls on Assay 

4. Open a Control Vial containing the Control Reagent. 

5. Remove the Chembio DPP Ebola Antigen System Test 

Device from its pouch and place it on a flat surface (It is not 

necessary to remove the desiccant from the pouch). 

6. Label the Test Device with Control Reagent name or 

identification number. 

7. Note that the DPP test device has 2 colored lines in the 

Test Window; one is blue and the other is green. If the 2 

colored lines are absent, DO NOT USE. Discard the test 

device and use a new test device. 

8. Use a laboratory pipet to withdraw 50μL of the control 

sample. 

9. Pipette the sample into Sample + Buffer Well 1 of the DPP 

Test Device, 

10. Test immediately, following Test Procedure instructions. 

Page 2 of 3 

a. Immediately after the addition of the control material, 

add 3 drops of DPP® Ebola Antigen System Buffer 

(Green Cap) into the same well (Well 1). To add the 

buffer, invert the DPP Ebola Antigen System Buffer 

(Green Cap) and hold it vertically (at a 90o) over Well 

1. Squeeze the bottle to slowly add 3 drops. 

NOTE: The Control Reagents are clear to strawcolored. 

b. Wait 5 minutes. The blue and green colored lines 

should have disappeared from the rectangular TEST 

and CONTROL window. If not, discard the test device 

and repeat the procedure with a new DPP test device. 

c. Invert the DPP Ebola Antigen System Buffer (Green 

CAP) and hold it vertically (not at an angle) over 

BUFFER Well 2. Slowly add 6 drops of DPP Ebola 

Antigen System Buffer (GREEN CAP) to BUFFER 

Well 2. 

d. Read the test result 10 to 15 minutes after the addition 

of the DPP Ebola Antigen System Buffer to BUFFER 

Well 2. In some cases, a test line may appear in less 

than 10 minutes however, 10 minutes are needed to 

report a nonreactive result. Read results in a well-lit 

area. Do not read results after 15 minutes from the 

addition of the Running Buffer to BUFFER Well 2. 

11. Discard the used pipet tips, Test Device and any other test 

materials into a biohazard waste container. 

12. Reseal the Control Reagent Vials and store them in their 

original container at 2 to 8°C (36 to 46°F). 

QUALITY CONTROL 

Built-in Control Feature 

The control line serves as a built-in internal control and gives 

confirmation of sample addition and proper test performance. A 

pink/purple line will appear in the CONTROL area if the test has 

been performed correctly and the Device is working properly 

(Please see section: Interpretation of Test Results). 

INTERPRETATION OF TEST RESULTS 

Read the test result between 10 to15 minutes after the addition of 

the running buffer to well 2 of the DPP® device (see interpretation 

of results section 3 below). Follow the DPP Micro Reader 

instruction manual. 

EXPECTED RESULTS 

1. DPP Ebola Non-Reactive Control: 

The DPP Ebola Non-Reactive Control will produce a 

NONREACTIVE (EVD-) Test Result. The reader will display the 

following result: 

EVD - 2. DPP Ebola Reactive Control: 

The DPP Ebola Reactive Control will produce a REACTIVE 

(EVD+) Test Result. The reader will display the following result: 

EVD + 

10-6297-0 Rev 1 

Nov 9, 2018 
SYMBOL LEGEND 

CONSULT THE MANUAL BEFORE USE 

CAUTION, CONSULT ACCOMPANYING 

DOCUMENTS. 

DO NOT REUSE 

FOR USE WITHIN TEMPERATURE LIMITS 

IN VITRO DIAGNOSTIC MEDICAL DEVICE 

BATCH CODE 

PRODUCT CATALOG NUMBER 

MANUFACTURERS IDENTIFICATION 

DATE OF MANUFACTURE 

USE BY DATE 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

3. INVALID – 

.An INVALID (INV) test cannot be interpreted. It is recommended 

that the INVALID test be repeated with a new device. If results are 

still invalid collect a fresh sample or test by another method. 

INV 

NOTE: If the Test Result for the DPP Ebola Non-Reactive 

Control or DPP Ebola Reactive Control is not as expected, the 

test should be repeated using a new Test Device and Control 

Specimen. If the Ebola control reagents do not produce the 

expected results and you are unable to obtain a valid Test Result 

upon repeat testing contact Chembio Diagnostic Systems 

Customer Service at 1-631-924-1135 ext. 112. 

LIMITATIONS 

The Chembio DPP Ebola Reactive Control and DPP Ebola NonReactive Controls are quality control reagents for use ONLY with 

Chembio DPP Ebola Antigen Assay. 

REFERENCES 

1. CDC’s 2014 Guideline for Isolation Precautions: Preventing 

Transmission of Infectious Agents in Healthcare Setting 

Available from: http://www.cdc.gov/vhf/ebola/hcp/infectionprevention-and-control-recommendations.html 

2. August 1, 2014 CDC released guidance titled, ”Infection 

Prevention and Control Recommendations for Hospitalized 

Patients with Known or Suspected Ebola Hemorrhagic Fever in 

U.S. Hospitals.” Available from: 

http://www.cdc.gov/vhf/ebola/hcp/infection-prevention-andcontrol-recommendations.html 

3. Centers for Disease Control and Prevention, How U.S. Clinical 

Laboratories Can Safely Manage Specimens from Persons 

Under Investigation for Ebola Virus Disease Available from: 

http://www.cdc.gov/vhf/ebola/hcp/safe-specimenmanagement.html 

ORDERING INFORMATION 

61-1013-0 Chembio DPP® Ebola Antigen Assay 

System 

61-1050-0 Chembio DPP® Micro Reader 

60-9554-0 Chembio DPP® Ebola Rapid Test 

Control Pack 

CHEMBIO DIAGNOSTIC SYSTEMS, INC. 

3661 HORSEBLOCK ROAD 

MEDFORD, NY 11763 USA 

Tel: 1-844-CHEMBIO (844-243-6246) 

Fax: 1-631-924-2065 

Email: info@chembio.com 

Web Site: www.chembio.com 

10-6297-0 Rev 1 

Page 3 of 3 Nov 9, 2018 
 

 

 

 

 

 

 

 

 

 

 

 

 

 

61-1050-0 

1 Unit 

DPP® Micro Reader 

Read this User Guide completely before using the product. 

Storage conditions: Store between -20 to 80°C (-4 to 176°F) 

For use under the Emergency Use 

Authorization (EUA) only. 

For In Vitro Diagnostic Use. 

NAME AND INTENDED USE 

The DPP® Micro Reader –is for use with the DPP® Ebola Antigen System test device. 

SUMMARY AND EXPLANATION 

The DPP Micro Reader is a reflectance reader used to obtain test results from DPP Ebola Antigen System test device. The DPP Micro 

Reader minimizes human errors due to subjective visual interpretation; therefore, the results of the DPP Ebola Antigen System test 

devices are made specifically to be read with the DPP Micro Reader. Results must be read exclusively with the DPP Micro Reader. 

PRINCIPLES OF THE PROCEDURE 

The DPP Micro Reader is a portable, battery-powered instrument that captures an image of the test strip surface, verifies the 

presence and intensity of the control line and measures the line intensity at each of the test line positions; it interprets the results 

using a scoring algorithm, and reports a REACTIVE, NON-REACTIVE or INVALID result after approximately 3 seconds. A 14-segment 

liquid crystal display (LCD) on the top of the instrument shows the status of the instrument and displays the test results to the 

operator. 

The DPP Micro Reader is maintenance-free, not configurable by the user, and is operated with a single, multi-function button. 

MATERIALS PROVIDED 

Each kit contains: 

1 DPP Micro Reader with Ebola RFID sticker (includes 3 Lithium-ion, type CR2032 (3 V/230 mAh), coin cell batteries) 

1 DPP Cartridge Holder for use with DPP Ebola Antigen Test Device 

1 Custom Power Cable (USB) 

1 Power plug adapter 

1 Microfiber Cloth 

1 User Manual for the DPP Micro Reader 

WARNINGS AND PRECAUTIONS 

• For In Vitro Diagnostic Use. 

• Where indicated, DPP Ebola Antigen System test results must be read using the DPP Micro Reader and cannot be visually 

interpreted. 

• The DPP Micro Reader is calibrated and checked before shipping under strict quality control measures in order to guarantee a 

high degree of quality. Do not attempt to open, re-configure or re-calibrate the DPP Micro Reader. 

• Protection provided by this instrument may be impaired if the equipment is used in a manner not consistent with the 

instructions in this manual. 

• The DPP Micro Reader requires three (3) CR2032 (3 V/230 mAh) batteries to operate or must be plugged in through the power 

cable using the port located above the battery compartment and connecting it to a powered USB adapter or a powered USB 

hub. 

• Do not use the DPP Micro Reader in direct sunlight or exposed to bright light while reading results. 

• The DPP Micro Reader is designed for use on a clean, flat, horizontal surface. 

• Always ensure that the DPP Micro Reader is positioned correctly in the DPP Cartridge Holder. Incorrect positioning may lead to 

incorrect results. 

• The DPP Micro Reader can be operated at temperatures between 10 and 35°C (50 to 95°F) and between 20% and 85% humidity. 

Ensure that the DPP Micro Reader is brought to operating temperature before use. 

• Protect the DPP Micro Reader from liquids. Any liquid entering the DPP Micro Reader may damage it permanently. 

• Please follow the instructions in the product insert provided with the test kit regarding the disposal of test devices containing 

hazardous or infectious material. 

17-4049-0 Rev 1 

November 2018 

Page 1 of 7 
 

 

 

 

 

61-1050-0 

1 Unit 

• The DPP Micro Reader itself contains no biological hazards. However, contamination during use with biological hazards is 

possible. For cleaning and maintenance, refer to section CLEANING AND MAINTENANCE. 

STORAGE AND STABILITY 

The DPP Micro Reader should be stored at temperatures between -20 and 80°C (-4 to 176°F) and between 20% and 85 % humidity. It 

can be operated at temperatures between 10 and 35°C (50 to 95°F) and between 20% and 85% humidity. 

BATTERY LIFE 

Under continuous use, one set of batteries will last for approximately 250- 300 reads (exact number may vary depending on battery 

quality, temperature, and length of storage between uses). The status of the batteries is being monitored and shown on the reader 

display every time the reader is turned ON. Verify that the battery symbol is not blinking nor has any bars left. Replace the batteries 

when the battery symbol starts to blink. The batteries cannot be recharged and have to be disposed according to local regulations. 

Always have a spare set of three batteries. Please see section on BATTERY INSTALLATION below. Alternatively, the DPP Micro 

Reader can be powered using the USB power cable connected to a power source. 

UNPACKING AND SET-UP 

1. Before using the DPP Micro Reader, visually inspect the contents for damage. If damage is apparent, contact Chembio Diagnostic 

Systems, Inc. (Figure 1). 

2. Remove the reader from its protective wrapping. It is recommended that the packaging materials are retained for later use. 

3. Ensure that the reader and components are clean. Remove any dust or debris with a smooth, dry cloth. 

Figure 1: Package Content 

USB Cable 

DPP Micro 

Reader 

with Ebola 

RFID 

sticker 

Microfiber 

cloth 

Power 

plug 

adaptor 

DPP 

Cartridge 

Holder 

BATTERIES INSTALLATION AND REPLACEMENT 

The reader requires three (3) CR2032 (3 V/230 mAh) batteries, Lithium-ion Coin Cell batteries such as EnergizerTM ECR2032 3V 

LITHIUM; DURACELL DL2032B4 Battery, 2032, Lithium, 3V or equivalent. Replace the batteries when the battery symbol starts to 

blink. To replace the batteries, turn the battery cover with a smooth-edged coin 1⁄4 turn counterclockwise until it stops. Tilt the side 

with the battery cover down so it falls into your hand, as well as the batteries inside. Place three new Lithium-ion Coin Cell batteries 

with correct polarity orientation ('+' sign outward, see Fig. 2) into the battery compartment one by one. Replace the battery cover by 

pressing slightly with a coin and turning 1⁄4 turn clockwise until it stops. 

17-4049-0 Rev 1 

November 2018 

Page 2 of 7 
 

 

61-1050-0 

1 Unit 

NOTE: If the reader does not start after installing new batteries, clean the batteries with a dry cloth and make sure they are installed 

with the + side directed outwards. If it still does not start, try a set of fresh batteries. 

Figure 2: Battery Installation/Replacement 

Lithium-ion coin cell 

batteries required 

Batteries 

compartment 

Battery 

installed 

cover 

Battery 

correctly: 

open 

compartment 

(+) on top 

After changing the batteries, perform the following steps Note: the date that appears in step 3 (below) represents the manufacture 

date of the DPP Micro Reader. 

17-4049-0 Rev 1

November 2018 

Page 3 of 7 
 

 

 

61-1050-0 

1 Unit 

Using the DPP Micro Reader DPP Micro Reader 

The DPP Micro Reader has 3 components: The DPP Micro Reader with Ebola RFID sticker, the 

Cartridge Holder for use with DPP® Ebola Antigen System Test Device, and a USB Cable. 

DPP Ebola Ag 

RFID Sticker 

Assemble the DPP® Micro Reader: 

a) Check to make sure that the window at the bottom of the reader is clean of finger marks and dust or lint before 

using the reader (see CLEANING AND MAINTENANCE Section below).Use enclosed microfiber cloth to wipe free 

of marks, dust or debris following the Chembio Ebola Micro Reader User Manual instructions. 

Make sure the RFID Sticker refers to Ebola VP40. 

b) Place the Cartridge Holder on a flat surface. Align the angled edge on the bottom of the DPP Micro Reader with 

the corresponding angled corner of the holder socket and place the DPP Microreader in the holder socket. 

Openings for Reader Opening Wells 1 and 2 

Angled Corner 

Angled Edge 

DPP Micro Reader in Cartridge Holder 

c) To read a test, place the DPP Micro Reader in Cartridge Holder on top of the test device. Make sure the 

rectangular test window on the test device is aligned with the reading window of the reader. At the end of 

assembly, the black button, battery compartment and Buffer Well 1 on the test device should be facing the user 

DPP Micro Reader Cartridge Holder for Reader 

and Buffer Well 2 should be to the left of the user. 

DPP Micro Reader with Cartridge 

Holder on top of testing device 

Reading a test: 

a) 10 to 15 minutes after the addition of the DPP 

Ebola Antigen System Buffer to Well 2 as per STEP 

4 in the TEST PROCEDURE, push the operating 

button. “ON” should appear in the reading 

window. 

Reading 

Window 

Push this 

Button 

17-4049-0 Rev 1 

November 2018 

Page 4 of 7 
 

 

 

 

 

 

 

 

61-1050-0 

1 Unit 

b) Press the Operating Button again; the display will read “RFID”.

c) “TEST” will appear in the display window. 

d) Press the Operating Button and “RUN” will appear in the display window.

After approximately 3 seconds, a result for the DPP Ebola Antigen System Test Device will appear across the display. 

Record the result (refer to INTERPRETATION OF TEST RESULTS) as the reader does not record results. 

NOTE: The test result should be manually recorded immediately after the test is complete as the reader will turn off 

automatically after approximately 50 seconds of inactivity. The DPP Micro Reader device does not store or recall previous 

results. 

If the DPP Micro Reader does not detect a line in the CONTROL (C) area, then it will display “INV”, indicating that the test 

is INVALID. An INVALID result indicates a problem with running the test, either related to the specimen, the device, or the 

procedure followed. An INVALID test cannot be interpreted; it is recommended that the INVALID test be repeated with a 

new device. 

TURNING OFF THE READER 

There is no active function to shut off the DPP Micro Reader; it will turn off automatically after approximately 50 seconds of 

inactivity. 

CLEANING AND MAINTENANCE 

The outer case and display may be cleaned with a microfiber cloth lightly moistened with 70% isopropyl alcohol (IPA) or 10% bleach 

solution. Do not introduce cleaning solution or any liquid into the unit. Do not use a saturated towel, which may leak liquid into the 

case or display seams. Ensure that the DPP Micro Reader is dry and the surface is free of fluid prior to returning to use. 

Make sure that the window under the reader is clean of finger marks, dust and lint, which may interfere with the results. It can be 

wiped with a dry microfiber cloth, or a microfiber cloth lightly moistened with 70% isopropyl alcohol (IPA) to remove greasy or finger 

marks. 

SERVICING AND RE-ORDERING 

There are no user serviceable components in the unit with the exception of the replaceable batteries. For technical issues or 

questions, and to order a new reader, please contact Chembio Diagnostic Systems, Inc. 

17-4049-0 Rev 1 

November 2018 

Page 5 of 7 
 

 

 

 

 

61-1050-0 

1 Unit 

CUSTOMER SERVICE DEPARTMENT 

Call: 1-844-CHEMBIO (844-243-6246) 

Email: customerservice@chembio.com 

DISPOSAL 

As the DPP Micro Reader may be contaminated by infectious material, it should be disinfected according to the CLEANING AND 

MAINTENANCE section above before disposal. Remove the batteries before disposing of the expired device and dispose of the 

batteries in accordance with local regulations. 

MESSAGES 

Messages displayed by the DPP Micro Reader are described in the table below. For assay-specific messages, see the appropriate 

package insert. 

Message Type Meaning Action Recommended 

ON Status Reader is ready for use. None 

RFID Status Reader is ready 

for RFID. 

The RFID sticker is attached to the reader to obtain assay information. Press 

the button and reader will show TEST. 

TEST Status Reader is ready to run a DPP test 

device. 

Press the button and the reader will show RUN. 

RUN Status Reader is reading test results. None. 

OK Status Reader has recorded date and 

time information. 

Press the button one more time, the reader will show ‘ON’ and is now ready 

for use. 

ERR Error The device could not read 

the information 

from the RFID sticker. 

(1) Press the button briefly (<1 second), the display will show 'ON'. 

(2) Make sure the RFID sticker is attached to the side of the reader. After you 

press the button when the RFID word is in the display, the reader should show 

TEST. 

If the error occurs again, please contact Chembio Diagnostic Systems, Inc. 

DATE Error An expiry date 

appears to be exceeded. 

Check the expiration date of the reader, RFID sticker and the test device in 

use. 

SPECIFICATIONS 

Dimensions: 

Weight: 

Operation: 

Display: 

Storage capacity: 

Device measurement period: 

Power supply: 

Interface: 

Configuration: 

Measuring field: 

Lighting: 

Signaling device: 

Operating conditions: 

Storage conditions: 

Degree of protection: 

Lifetime: 

17-4049-0 Rev 1 

November 2018 

L x W x H: Approx. 1.6 x 1.6 x 1.6 in. (41 x 41 x 40 mm) 

Approx. 1.4 oz (40 g) 

One button operation 

14-segment LCD 

None 

Approx. 3 second 

3 batteries CR2032 (3 V/230 mAh) 

Or Micro-Reader specific power cord/USB cable 

4 pole – 0.1 in. (2.5 mm) jack plug for power supply (instead of battery 

Specific configuration program; RFID technology 

Min. 0.2 in. (4 mm) width; Max. 0.7 in. (18 mm) length 

Wavelength 525 nm 

Buzzer 

Between 50°F (+10°C) and 95°F (+35°C); between +20 % and +85 % humidity 

Between -22°F (-30°C) and 176°F (+80°C); between +20 % and 85 % humidity 

IP 20 

3,000 

Page 6 of 7 
 

 

 

 

 

61-1050-0 

1 Unit 

ORDERING INFORMATION 

61-1013-0 Chembio DPP® Ebola Antigen System 

60-9554-0 Chembio DPP® Ebola Rapid Test Control Pack 

61-1050-0 Chembio DPP® Micro Reader 

For Product Information please email info@chembio.com 

CHEMBIO DIAGNOSTIC SYSTEMS, INC. 

3661 HORSEBLOCK ROAD 

MEDFORD, NY 11763 USA 

Tel: 1-844-CHEMBIO (844-243-6246) 

Email: info@chembio.com 

Web Site: www.chembio.com 

SYMBOL LEGEND 

CONSULT THE MANUAL BEFORE USE 

CAUTION, CONSULT THE ACCOMPANYING DOCUMENTS 

FOR USE WITHIN TEMPERATURE LIMITS 

IN VITRO DIAGNOSTIC MEDICAL DEVICE 

PRODUCT CATALOG NUMBER 

MANUFACTURERS IDENTIFICATION 

DATE OF MANUFACTURE 

THIS DEVICE SHOULD BE TREATED AS WASTE 

EQUIPMENT AND DISPOSED OF AT DESIGNATED 

COLLECTION POINT 

READER POWER ACTUATION (ON/OFF) 

READER SERIAL NUMBER (13 DIGITS) 

PROTECTION CLASS OF ELECTRONIC EQUPMENT 

17-4049-0 Rev 1 

November 2018 

Page 7 of 7