Open Label, Single-Center Study Utilizing BIOZEK COVID-19 Antigen Rapid Test as Compared to Standard Testing Technique. Test Performed by a Professional Versus Self-collection and Standard of Care
Phase: NA
Conditions: Covid19
Sponsor: Mach-E B.V.

 
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BIOZEK Version: Final 1.0 – March 5, 2021 
 
 
Clinical Protocol BIOZEK  
 
 
Title:  
“Open label, Single-Center Study utilizing BIOZEK COVID-19 
Antigen Rapid Test as compared to standard testing technique.” 
Test performed by a professional versus self-collection and standard 
of care. 
  
Short title:  
 
 
Comparison of BIOZEK Antigen Rapid Test to  
 
 
 
 
COVID-19 RT-PCR. 
 
Protocol Number: 
 
Biozek-ARTC-US/001/3-5-2021 
  
Product:  
BIOZEK COVID-19 Antigen Rapid Test Cassette               
 
(Nasopharyngeal Swab) 
 
  
 
Contract Research Organization (CRO):   Jeanetta Stega, MD, PhD 
 
 
 
 
 
Principal Investigator: 
Damian Stega, M.D. 
Co-Principal Investigator:   Angela Khaitova 
Study Management  
and Monitoring:  
 
Sophia Dalia 
  
Study Coordinator:   
Sophia Dalia 
 
 
Version:  
 
 
Final 1.0  
 
Date:   
 
 
March 5, 2021 
 
 
 
CONFIDENTIALITY STATEMENT 
The information contained in this document, particularly unpublished data, is the property or 
under control of Biozek medical and is provided to you in confidence as an investigator, potential 
investigator, or consultant, for review by you, your staff, and an applicable Institutional Review 
Board or Independent Ethics Committee.  The information is only to be used by you in 
connection with authorized clinical studies of the investigational drug described in the protocol.  
You will not disclose any of the information to others without written authorization from Biozek 
Company, except to the extent necessary to obtain informed consent from those persons to whom 
the test may be performed. 
 
 
 
 
 
 
 
 
 

 
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BIOZEK Version: Final 1.0 – March 5, 2021 
 
1. Protocol Synopsis 
_____________________________________________________________________________ 
 
Title:  
“Open label, Single-Center Study utilizing BIOZEK COVID-19 
Antigen Rapid Test as compared to standard testing technique.” Test 
performed by a professional vs self-collection and standard of care. 
 
Study Site  
 
Sample Collection:     Mobile Covid Services LLC 
3050 Whitestone Expressway, Suite 402 
Flushing, NY, 11354 
            Sigmund Laboratory for RT-PCR test 
 
78 John Miller Way Ste 1001 
 Kearny, NJ 07032 
 
Number of Subjects  
Planned: 
 
Up to 250 Subjects, minimum of 30 positive and 30 negative tests.  
 
Study Objectives:  
Primary:  
To assess sensitivity and specificity of BIOZEK COVID-19 Antigen 
Rapid Test on a sample collected by a healthcare professional. 
 
Secondary:  
To assess sensitivity and specificity of BIOZEK COVID-19 Antigen 
Rapid Test on a self-collected sample. 
 
To assess if the result of each BIOZEK COVID – 19 Antigen Rapid Test 
performed by the subject are the same as the results of the test performed 
by a healthcare professional. 
 
Target Population:  Subjects, at least 18 years of age who desire a Covid-19 RT-PCR test. 
Subjects must meet inclusion and exclusion criteria. 
 
Investigational  
Product:  
 
BIOZEK COVID-19 Antigen Rapid Test Cassette (Nasopharyngeal Swab) 
 
Comparator:   
Type of test: RT-PCR 
Name of test: Lyra Direct SARS-CoV-2 Assay 
Manufacturer: Quidel Corporation 
 
 
Study Design: 
Up to 250 symptomatic subjects of age 18 or older that meet the inclusion      
and exclusion criteria and are willing to participate will be enrolled into 
the BIOZEK study. All subjects will be required to sign an informed 
consent form.  
 
Participants will complete a personal information form and a testing site 
personnel will collect medical history and vital signs will be recorded. 

 
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BIOZEK Version: Final 1.0 – March 5, 2021 
 
Medical clearance will be obtained prior to performing any sample 
collection. 
 
 
 
 
Subject will have 3 tests performed in a manner described below: 
 
1.RT-PCR test (by medical staff prior to enrollment as a standard of care procedure), 
Additionally Ct value will be requested. Turnaround time for RT-PCR test results is 1-2 days.  
 
2.BIOZEK COVID-19 Antigen Rapid Test (via self-collection),  
Nasopharyngeal samples will be collected via self-collection and the test will be performed by 
the subject. The participants will follow instructions for use provided by Biozek together with 
the test. The subject’s performance during self-collection and test performance will be monitored 
and recorded in a performance form. Results in 15 minutes.   
 
3. BIOZEK COVID-19 Antigen Rapid Test (by medical staff).   
Second, a nasopharyngeal sample will be collected and a test will be performed by a medical 
professional.  Results for the test in 15 minutes. A coordinator will monitor patient concerns 
during and after collection and an image will be captured of the results of both tests for record 
and in subject’s CRF. Compliant to all procedures for disposal of biohazardous waste. 
 
Results will be retrieved from the PCR test when available and all three samples will be analyzed 
and compared.  
 
Criteria for Evaluation: 
 
Safety Criteria:  
During self-collection the subject will be closely monitored according to 
standard of care and any adverse effects will be captured. During the test 
performed by a healthcare professional, the subjects in this study will not 
be exposed to additional risk from interventional procedures, because the 
ones to be used are the standard of clinical practice.  
 
Efficacy Criteria:  
Sensitivity and Specificity will be calculated separately for BIOZEK 
COVID-19 Antigen Rapid Test on a sample collected by healthcare 
professionals and for BIOZEK COVID-19 Antigen Rapid Test on the self-
collected sample. 
 
 
Additionally, the result of each test performed by the subject will be 
compared to the test performed by a healthcare professional. 
 
End Points: 
Primary: Sensitivity and Specificity of BIOZEK COVID-19 Antigen 
Rapid Test on a sample collected by healthcare professionals. 
 
Secondary: Sensitivity and Specificity of BIOZEK COVID-19 Antigen 
Rapid Test on self-collected sample. 
 
Tertiary: Number of tests with overlapping results. 
 
 

 
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BIOZEK Version: Final 1.0 – March 5, 2021 
 
 
 
 
 
 
 
 
Table of Contents 
1. Protocol Synopsis 
2 
2. Introduction 
5 
3. Background 
5 
4. Study Objectives: 
6 
5. Investigational Product 
6 
6. Study Population 
12 
6.1 Inclusion Criteria 
12 
6.2 Exclusion Criteria 
12 
6.3 Sample Size 
12 
6.4 Confirmation of Patient Enrollment 
12 
6.5 Patient Identification 
12 
6.6 Removal, Replacement, or Early Withdrawals of Subjects 
12 
7. Overview of Investigational Plan and Study Administration 
13 
7.1 Enrollment 
13 
7.2 Material and Methods 
13 
7.3 Premature Discontinuation 
15 
7.4 Protocol Violations 
15 
7.5 Compliance 
16 
8. Data analysis. 
16 
9. Ethics 
16 
9.1 Hospital Ethics Committee/Institutional Review Board 
16 
9.2 Ethical Conduct of the Study 
16 
9.3 Subject Information and Consent 
17 
10.References 
17 
 
 
 
 
 
 

 
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BIOZEK Version: Final 1.0 – March 5, 2021 
 
 
 
 
2. Introduction 
 
 
Widespread testing is the cornerstone of COVID-19 control around the world. However, U.S. 
testing to identify people with infected SARS-CoV-2 has been slow to start and continues to lag. 
An important feature of SARS-CoV-2 is that it can be transmitted while a host is unaware of 
infection (asymptomatic). Epidemiologic evidence has demonstrated that pre-symptomatic and 
asymptomatic transmission of virus has driven the current epidemic1. Antigen tests have a great 
potential for screening asymptomatic people2. To limit outbreaks, testing is needed to identify as 
many individuals who are transmitting infection as quickly as possible. Antigen Tests have the 
potential to readily identify an individual who is at or near peak infection. Rapid Tests, while less 
sensitive, perform best during the early stages of COVID-19 infection; when viral load and 
potential for spread is high.  
 
There is an unmet need to provide broad testing that can serve high risk and low resource 
communities. The FDA’s authorization for antigen tests for home use is helping to expand 
Americans’ access to testing, reducing the burden on laboratories and test supplies3. The Biozek 
Antigen Rapid Test can be easily performed by untrained personnel with results in less than 15 
minutes. The increased potential for repeated testing, remote or at home testing, could help 
contain the COVID-19 pandemic.  
 
3. Background 
_____________________________________________________________________________ 
 
In December 2019, an outbreak emerged identifying a novel coronavirus, severe acute 
respiratory syndrome coronavirus 2 (SARS-CoV-2). The World Health Organization (WHO) 
declared it a global pandemic in March 2020.  Testing in the U.S. appeared to be insufficient for 
optimal early containment of the virus. With the resurgence of the disease (COVID-19), the U.S. 
has recently seen the highest number of hospitalizations since the beginning of the pandemic and 
rates are expected to increase in future weeks4. Given the continued community transmission of 
SARS-CoV-2 in the US, there has been sustained focus on the role of testing to reduce the 
spread. Presently, the gold standard polymerase chain reaction (PCR) test is used to diagnose 
COVID-19 by detecting the presence of specific genetic material of the virus. PCR test requires 
laboratory processing and it may take days to obtain results. In turn, an individual could be 
negative at time of testing but positive by the time the result is returned5. PCR testing is 
performed by a trained healthcare professional at an approved testing facility. In contrast, The 
BIOZEK Rapid Antigen Test detects specific proteins on the surface of the virus and it can be 
self-administered. Results are generated in 15 minutes and can be performed at home or any 
remote location. In efforts to meet the exponential demand in testing, the introduction of a new 
and effective Rapid Test could potentially end the spread of COVID-19.  
 

 
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BIOZEK Version: Final 1.0 – March 5, 2021 
 
4. Study Objectives:  
_____________________________________________________________________________ 
 
The primary objective of the study is to assess sensitivity and specificity of BIOZEK COVID-19 
Antigen Rapid Test on a sample collected by healthcare professionals.  
 
Secondary objectives are to assess sensitivity and specificity of BIOZEK COVID-19 Antigen 
Rapid Test on self-collected samples.  
 
Additionally, the objective is to achieve the same results from the tests performed via self- 
collection and by the healthcare professionals. Such a comparison would demonstrate any 
distinctions between tests performed by healthcare professionals and by the subject.  
 
RT-PCR Ct Values will be requested and analyzed. 
 
5. Investigational Product 
_____________________________________________________________________________ 
 
The BIOZEK COVID-19 Antigen Rapid Test Cassette (Nasopharyngeal Swab) is a qualitative 
membrane-based immunoassay for the detection of SARS-CoV-2 Antigens in human 
nasopharyngeal swab specimens. SARS-CoV-2 antibody is coated in the test line region. During 
testing, the specimen reacts with SARS-CoV-2 antibody-coated particles in the test. The mixture 
then migrates upward on the membrane by capillary action and reacts with the SARS-CoV-2 
antibody in the test line region.  
If the specimen contains SARS-CoV-2 Antigens, a colored line will appear in the test line region 
as a result of this. If the specimen does not contain antigens to SARS-CoV-2, no colored line will 
appear in the test line region, indicating a negative result. To serve as a procedural control, a 
colored line will always appear in the control line region, indicating that the proper volume of 
specimen has been added and membrane wicking has occurred. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
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BIOZEK Version: Final 1.0 – March 5, 2021 
 
 
 
Materials provided in the BIOZEK-COVID-19 Antigen Rapid Test kit includes: Test cassettes, 
Sterile Swabs, Extraction tubes and tips, Extraction Buffer, Workstation, Package Insert. 
 
 
Contents of Biozek Covid-19 Antigen Rapid test. 
 
Disposable sampling Swab: 
Production: Jiangsu Hanheng Medical 
Technology Co 
Place of Origin: Jiangsu, China 
Brand Name:  HanHeng  
Disinfecting Type: EO sterilization 
Size: 15.2cm with 8.5cm breakpoint 
Shelf Life: 5 years 
Material: 100% Nylon, Nylon floss tip +PP rod 
Quality Certification: ce 
Safety standard: EN 149 -2001+A1-2009 
Product name: nasal swab 
Property: sample collection 
Certificate: CE/ISO13485 
Product Certification  
CE Certified. Valid from 2019-11-25 until 2024-05-27  
Description of Test Steps:  
Specimen Collection  
1. Insert a provided sterile swab into the nostril of the patient carefully, reaching the surface of 
the posterior nasopharynx.  
2. Swab over the surface of the posterior nasopharynx gently.  
3. Withdraw the sterile swab from the nasal cavity.  
 
 

 
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BIOZEK Version: Final 1.0 – March 5, 2021 
 
 
 
 
4. 
Swab specimens should be extracted and tested as soon as possible after swab specimen 
collection.  
 
Specimen Extraction 
Only the extraction buffer and/or tubes provided in this kit is to be used for specimen extraction.  
 
Swab specimen extraction with pre-filled integrated buffer tube (Option 1)  
1. Unscrew the cap of the extraction tube with the extraction buffer inside.  
2. Place the swab specimen into the extraction buffer, for better mixture and extraction to release 
antigen, rotate the swab for approximately 10 seconds while pressing the swab head against the 
inner wall of the tube at least 5 times to release the antigen.  
3. Remove the swab while squeezing the swab head against the inner wall of the tube to get 
maximum solution left inside the extraction tube. Dispose of the used swab in your biohazard 
waste.  
4. Tighten the cap onto the sample extraction tube. Use the extracted sample solution as a final 
sample for testing as soon as possible.  
 
Swab specimen extraction with extraction buffer and tube separately (Option 2&3)  
(Extraction buffer in 10mL buffer bottle or disposable buffer vial)  
1. Place the extraction tube in the workstation and add approx. 350μL Extraction Buffer into the 
extraction tube as following:  
Extraction buffer in 10mL bottle: Add 10 drops of extraction buffer into the tube.  
Extraction buffer in disposable buffer vial: Tear to open the small disposable vial and add the 
Entire Extraction Buffer into the tube.  
2. Place the swab specimen into the extraction buffer. Rotate the swab for approximately 10 
seconds while pressing the head against the inner wall of the tube 5 times to release the antigen.  

 
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BIOZEK Version: Final 1.0 – March 5, 2021 
 
3. Remove the swab while squeezing the swab head against the inner wall of the tube to get 
maximum solution left inside the extraction tube. Dispose of the used swab in your biohazard 
waste.  
4. Fit the tip onto the top of the extraction tube. Use the extracted sample solution as a final 
sample for testing as soon as possible.  
 
NOTE: For extraction buffer in 10mL bottle, it is suggested not to use the extraction buffer 
beyond 3 months after opening the extraction buffer bottle.  
 
 
 
 
 
 
 
Viral Transport Media (VTM) specimen extraction  
1. VTM should not contain guanidinium.  
2. When using Viral Transport Media (VTM) specimen, it is important to ensure that the VTM 
containing the swab specimen has been balanced to room temperature (15- 30°C).  
3. Using a pipette to transfer 350μL VTM specimen into the specimen extraction tube with 
approx.350μL extraction buffer inside, shake to mix it well for extraction. Use the extracted 
sample solution as a final sample for testing as soon as possible.  
 
NOTE: The storage of the extracted specimen is stable for 2 hours at room temperature or 24 
hours at 2-8°C. 
 
Standard Testing Procedure  
Allow the test, extracted specimen and/or controls to equilibrate to room temperature (15-30°C) 
prior to testing.  
 
Remove the test cassette from the sealed foil pouch and use it within one hour. Best results will 
be obtained if the test is performed immediately after opening the foil pouch.  
 
Invert the specimen collection tube and add 3 drops of the extracted specimen (approx.75μl) to 
the specimen well(S) and then start the timer. | 
 
Wait for the colored line(s) to appear. Read the result in 15 minutes. Do not interpret the result 
after 20 minutes.  

 
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BIOZEK Version: Final 1.0 – March 5, 2021 
 
 
 
Figure 1: Interpretation of Results for Test Cassette 
 
After the test is performed, remaining material should be disposed of in biohazard disposal. 
 
Control Material: 
Internal Quality Control 
An internal procedural control is included in the test. A colored line appearing in the control 
region (C) is an internal positive procedural control. It confirms sufficient specimen volume and 
correct procedural technique. A clear background is an internal negative procedural control. If 
the test is working properly, the background in the result area should be white to light pink and 
not interfere with the ability to read the test result.  
 
External Quality Control 
Positive and negative controls are not included in this kit.  
 
 
Interpretation of results 
POSITIVE: * Two distinct colored lines appear. One colored line should be in the control region 
(C) and another colored line should be in the Test region (T). A positive result in the Test region 
indicates detection of COVID-19 antigens in the sample.  
*NOTE: The intensity of the color in the test line region (T) will vary based on the amount of 
COVID-19 antigen present in the sample. Any shade of color in the test region (T) should be 
considered positive.  
 
NEGATIVE: One colored line appears in the control region (C). No apparent colored line 
appears in the test line region (T). INVALID: Control line fails to appear in the control region 
(C). Insufficient specimen volume or incorrect procedural techniques are the most likely reasons 
for control line failure. Review the procedure and repeat the test with a new cassette. If the 
problem persists, discontinue. 
 

 
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If the specimen contains SARS-CoV-2 Antigens, a colored line will appear in the test line region 
as a result of this. If the specimen does not contain antigens to SARS-CoV-2, no colored line 
will appear in the test line region, indicating a negative result. To serve as a procedural control, 
a colored line will always appear in the control line region, indicating that the proper volume of 
specimen has been added and membrane wicking has occurred. 
 
As shown in illustration above, the specimen (A) migrates via capillary action along the 
membrane to react with the colored conjugate (B). COVID-19 antigen present in the specimen 
binds to the conjugate, forming a colored antibody-antigen complex. The Anti-SARS-CoV2 
immobilized in the test zone of the membrane captures the test region (C). The formation of a 
visible colored line in the test region indicates a positive result (C). The absence of a colored 
line in the test zones suggests a negative result. In the control zone of the membrane, 
immobilized reagents capture colored conjugate regardless of test specimen composition. The 
resulting visible colored band (D) confirms the control line. 
 
How to Store Biozek COVID-19 Antigen rapid test. 
Store the BIOZEK COVID-19 Antigen Rapid Test Cassette (Nasopharyngeal Swab) packaged in 
the sealed pouch and extraction buffer at room temperature or refrigerated (2-30°C). The test and 
extraction buffer are stable through the expiration date printed on the sealed pouch and buffer 
label. The test must remain in the sealed pouch until use. DO NOT FREEZE. Do not use the kit 
beyond the expiration date. Do not use the kit if the package of the test cassette or buffer is 
damaged. 
 
 
 
 

 
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BIOZEK Version: Final 1.0 – March 5, 2021 
 
 
6. Study Population  
_____________________________________________________________________________ 
 
6.1 Inclusion Criteria  
 
Subjects must be ≥18 years of age and have had an RT-PCR test performed prior to enrollment. 
Subjects must be able to understand and willingly sign a written informed consent. Additionally, 
participants need to meet at least 1 of the criteria listed below: 
● Currently experiencing symptoms of COVID-19. 
● Be clinically diagnosed or suspected to have COVID-19. 
● Recent past (3 weeks) exhibited symptoms of COVID-19. 
● Be capable of performing a self-collection of a nasopharyngeal sample with use of nasal 
swab kit. 
● Interacted with a COVID-19 positive individual. 
 
6.2 Exclusion Criteria  
 
Subjects who meet any of the following exclusion criteria may not be enrolled in this study:  
● Cannot perform self-collection of a nasopharyngeal sample with use of nasal swab kit. 
● Have a deviated nasal septum. 
● Cognitively impaired individuals resulting in the inability to provide informed consent 
6.3 Sample Size  
 
Up to 250 subjects will be enrolled in the study. The study shall be continued until at least 30 
positive and 30 negative tests results are obtained. 
  
6.4 Confirmation of Patient Enrollment  
 
Patient enrollment into the study will be confirmed by onsite Study Monitor.  
 
6.5 Patient Identification  
  
During the study, the Study Monitor will submit a daily summary to Quality Research and 
Invention LLC, with the total number of subjects enrolled that day to the study. Patient numbers 
will be assigned sequentially as patients are enrolled at the site. Once assigned, patient numbers 
will not be re-used. Each patient’s screening number will be recorded on every page of the CRF. 
In any correspondence or communication with the Sponsor, patients should be referred to by the 
screening number and initials only. 
 
6.6 Removal, Replacement, or Early Withdrawals of Subjects 
 

 
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BIOZEK Version: Final 1.0 – March 5, 2021 
 
Patients who withdraw following the commencement of study treatment due to any reason will 
not be replaced.  
 
7. Overview of Investigational Plan 
_____________________________________________________________________________ 
 
7.1 Enrollment 
 
● Participants will be recruited; 
● Subject to be screened and deemed eligible by the study personnel for enrollment; 
● Patient details to be entered onto the information form; 
● Site enrolls patients and assigns patient screening numbers. 
 
 
 
7.2 Material and Methods 
 
Enrollment will take place at the Mobile Clinic. The Enrollment population consists of up to 250 
symptomatic patients scheduled for an appointment, at a Mobile Clinic, to perform an RT-PCR 
test for SARS-CoV-2 as the standard of care procedure. After arrival, all patients who have 
received an RT-PCR test will complete a COVID Screening Intake Form and will be asked if 
they are willing to participate in the BIOZEK study after their scheduled RT-PCR test has been 
performed. After obtaining medical clearance, a medical staff member will collect samples for 
RT-PCR test and will send it to the Sigmund Laboratory for testing. The results will be available 
in 1-2days. Results and Ct value of the RT-PCR test from subjects enrolled to the study will be 
collected by study personnel. 
 
If the subject is age 18 or older and meets the inclusion and exclusion criteria, they will sign an 
Informed Consent Form and will be enrolled into the BIOZEK study. A study coordinator will 
take the subject’s body’s surface temperature and will capture it in the CRF.  
  
An additional two samples will be collected for the BIOZEK COVID-19 Antigen Rapid Test. 
The first test will be performed by the subject, via self-collection of the sample, following 
instructions provided by Biozek Company. The second test will be performed by a trained 
medical professional. 
 
Subject will open the Biozek package with a test and will read instructions in package insert. 
Materials provided in the BIOZEK-COVID-19 Antigen Rapid Test kit includes: Test cassettes, 
Sterile Swabs, Extraction tubes and tips, Extraction Buffer, Workstation. 
 
 
First sample collection- BIOZEK COVID-19 Antigen Rapid Test 
A nasopharyngeal sample will be collected via self-collection and the test will be performed by 
the subject. The subject will follow simplified instruction provided with the test. (Instructions 
listed below and the full instruction is also attached). Medical professionals will monitor and 
record any difficulties. 

 
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BIOZEK Version: Final 1.0 – March 5, 2021 
 
 
 
 
 
 
BIOZEK COVID-19 Rapid Test 
DIRECTIONS 
Read all of these directions before starting 
 
 
1. Open the swab package. 
2. Twist top off the small plastic vial and squeeze the liquid into the plastic specimen tube, 
making sure the specimen tube stays upright. 
3. Collect the specimen from your nose. 
a. Gently insert the swab into your nose, all the way to the back of the nasal cavity. (NOTE: 
Aim the swab towards the back of your head, not towards the top, as your nasal cavity 
connects back to your ears) 
a. When the swab can't be pushed any further (inserted about 3”) rotate it 3 times and gently 
and carefully remove the swab. 
4. Insert the swab into the specimen tube. 
a. Rotate the swab for 10 seconds against the wall of the tube. 
b. Squeeze the bottom of the tube several times while stirring. 
5. Remove the swab while squeezing the tube to get the maximum solution out of the swab. 
6. Place the plastic tip on the specimen tube. 
7. Open the test cassette and place it on a level surface. 
8. Shake the specimen tube for 10 seconds. 
9. Invert the specimen tube and put 3 drops into the specimen well of the cassette test kit. 
 
10. Wait for 15 minutes and read the results. 
 
 
 
 
 
Test Results  
 

 
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BIOZEK Version: Final 1.0 – March 5, 2021 
 
After interpreting the results, the coordinator will take an image of the cassette to be recorded 
and captured in the CRF. Compliant to all procedures required for disposal of biohazardous 
waste. 
 
Second sample collection- BIOZEK COVID-19 Antigen Rapid Test 
A nasopharyngeal sample collection and the test will be performed by a medical professional. 
The medical professional is trained and will not require instructions to perform the test.  
After specimen collection, the coordinator records any indication of an adverse event and it is 
captured in the CRF. All data collected is to be captured in the subject's CRF. 
The swab specimens should be extracted and tested as soon as possible after specimen collection.  
After interpreting the results, the coordinator will take an image of the cassette to be recorded 
and captured in the CRF. Compliant to all procedures required for disposal of biohazardous 
waste. 
RT-PCR test collection and processing will follow the standard of care procedure. In addition, Ct 
values will be requested from the laboratory. Turnaround time for RT-PCR test results is 1-2 
days. When the results from PCR test will be available study personnel will collect them from 
Sigmund Laboratory. All three results will be compared. 
All data collected from the three samples will be transferred to Quality Research and Invention, 
LLC for analysis. 
 
7.3 Premature Discontinuation  
 
Patients may be withdrawn from the study for the following reasons:  
● at patient’s own request or at the request of their legally authorized representative 
● if, in the opinion of the Investigators, continuation in the study would be detrimental to 
the subject’s well-being 
● at the specific request of the Sponsor.  
 
Patients must be withdrawn from the study under the following circumstances: 
● intolerable sample collection procedure 
● any event that in the judgment of the Investigators poses an unacceptable safety risk to 
the patient 
● study closure 
 
In all cases, the reason for withdrawal must be recorded in the CRF and in the patient’s medical 
records.  
 
7.4 Protocol Violations  
 
Protocol violations include any deviations from this protocol, regardless of prior approval of the 
violation. A major protocol violation would include the following: 
● enrollment of a patient who does not meet the inclusion/exclusion criteria 
● enrollment of a patient who has not signed an informed consent form 
● the patient has missed the sample collection visit(s) 
 
Any protocol violation must be reported immediately to the Sponsor and to the IRB.  
 

 
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7.5 Compliance  
 
This study will be conducted in accordance with ICH-Good Clinical Practice guidelines.  
 
 
7.6 Risks  
 
During self-collection the subject will be closely monitored according to standard of care and 
any adverse effects will be documented. During the test performed by healthcare professionals 
the subjects in this study will not be exposed to additional risk from interventional procedures, 
because the ones to be used are the standard of clinical practice.  
 
8. Data analysis 
_____________________________________________________________________________ 
 
The data will be collected and analyzed by Quality and Invention team. 
Results of RT-PCR, BIOZEK COVID-19 Antigen Rapid Test on a sample collected by 
healthcare professionals, BIOZEK COVID-19 Antigen Rapid Test on self-collected samples will 
be analyzed. Additionally, Ct values for RT-PCR will be obtained. 
RT-PCR is a golden standard in diagnosis of Covid-19. The results obtained by Biozek tests will 
be compared to results of RT-PCR test. 
Sensitivity and specificity will be calculated. 
 
9. Ethics 
_____________________________________________________________________________ 
 
9.1 BRANY Institutional Review Board  
 
Prior to initiation of the study, the Principal Investigators will submit the study protocol, sample 
Informed Consent Form, and any other documents that may be requested to their respective 
BRANY IRB for review and approval. The Principal Investigators will request that the BRANY 
IRB provide written approval of the study and will keep on file records of approval of all 
documents pertaining to this study.  
 
The BRANY IRB will have at all times the right to review all source documents. 
The BRANY IRB will be notified of any amendments to the protocol. Those amendments will 
require approval of the BRANY/IRB prior to being incorporated into the study.  
 
9.2 Ethical Conduct of the Study 
  
This trial will be conducted in compliance with the protocol, Good Clinical Practices (GCP), and 
the applicable regulatory requirements. 
 

 
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BIOZEK Version: Final 1.0 – March 5, 2021 
 
9.3 Subject Information and Consent  
 
Prior to screening for the study, each subject will be informed in detail about the study 
procedure, and the nature of the clinical investigation with its risks and discomforts to be 
expected. The principles of informed consent as specified by ICH-GCP will be followed. Any 
amendments to the Informed Consent form will need to be approved by the BRANY IRB. 
Written consent will be obtained from each subject to be involved in the clinical trial by using 
the BRANY IRB-approved Informed Consent Form. Consent will be verified by the Principal 
Investigator and a witness (where applicable). Each subject will be given a copy of the Informed 
Consent Form. The subjects will also be instructed that they are free to withdraw their consent 
and discontinue their participation in the study at any time without prejudice.  
 
 
10.References 
_____________________________________________________________________________ 
 
1)   
Manabe, Y., Sharfstein, J. and Armstrong, K., 2021. The Need for More and 
Better Testing for COVID-19.   
2) 
Rubin, R., 2021. The Challenges of Expanding Rapid Tests to Curb COVID-19. 
3)    
U.S. Food and Drug Administration. 2021. Coronavirus (COVID-19) Update: 
FDA Authorizes Antigen Test as First Over-the-Counter Fully At-Home Diagnostic Test 
for COVID-19. [online] Available at: <https://www.fda.gov/news-events/press- 
4) 
Centers for Disease Control and Prevention. 2021. COVIDView, Key Updates. 
[online] Available at: <https://www.cdc.gov/coronavirus/2019-ncov/covid-
data/covidview/index.html> [Accessed 11 February 2021]. 
5) 
Centers for Disease Control and Prevention. 2021. COVID-19 and Your Health. 
[online] Available at: <https://www.cdc.gov/coronavirus/2019-ncov/symptoms-
testing/testing.html> [Accessed 11 February 2021].