Open Label, Single-Center Study Utilizing BIOZEK COVID-19 Antigen Rapid Test: Comparison of Biozek COVID-19 Antigen Rapid Test Results Performed on Self-collected Samples by the Subjects, to Results of COVID-19 RT-PCR as a Standard of Care
Phase: NA
Conditions: Covid-19 Testing
Sponsor: Mach-E B.V.

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BIOZEK Final 4.0 – June 1, 2021 
 
 
Clinical Protocol BIOZEK  
 
 
Title:  
“Open label, Single-Center Study utilizing BIOZEK COVID-19 
Antigen Rapid Test.” 
                                                 Comparison of Biozek COVID-19 Antigen Rapid test results                
                                                 performed on self-collected samples by the subjects, to results of  
                                                 COVID-19 RT-PCR as a standard of care. 
 
  
Short title:  
 
 
Comparison of BIOZEK Antigen Rapid Test to  
 
 
 
 
COVID-19 RT-PCR. 
 
Protocol Number: 
 
Biozek-ARTC-US/002/4-12-2021 
  
Product:  
BIOZEK COVID-19 Antigen Rapid Test Cassette               
 
Nasopharyngeal Swab  
 
 
 
 
 
 
 
BIOZEK COVID-19 Antigen Rapid Test Cassette 
 
 
 
 
Oral Fluid 
 
 
 
 
  
 
 
Principal Investigator: 
Janetta Stega, M.D., PhD 
Co-Principal Investigator:   Damian Stega, M.D 
 
 
  
Study Coordinator:   
Sophia Dalia 
 
 
Version:  
 
 
Final 4.0 
 
  
 
Date:    
 
 
 June 1, 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The information contained in this document, particularly unpublished data, is the property or 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 Final 4.0 – June 1, 2021 
 
1. Protocol Synopsis 
_____________________________________________________________________________ 
 
Title:  
“Open label, Single-Center Study utilizing BIOZEK COVID-
19 Antigen Rapid Test.” 
Comparison of Biozek COVID-19 Antigen Rapid Test 
results performed on self-collected samples by the subjects, 
to results of COVID-19 RT-PCR as a standard of care. 
 
 
      
 
 
Number of Subjects  
Planned: 
 
 
Up to 250 Subjects, minimum of 30 positive and 30 negative tests.  
 
Study Objectives:  
To assess sensitivity and specificity of BIOZEK COVID-19 
Antigen Rapid Test on a self-collected sample and self-performed 
test by subject (nasopharyngeal swab and oral fluid).  
 
To assess subject’s performance to collect samples and conduct 
BIOZEK COVID-19 Antigen Rapid Test. 
 
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  
 
 
BIOZEK COVID-19 Antigen Rapid Test Cassette  
Oral Fluid 
 
 
 
Comparator:   
 
Type of test: RT-PCR 
Name of test: Atila BioRad 
                      BioFire 
 
          Luminex Aires 
 
 
 
 
 
 
 
 
Study Design: 
Up to 250 (30 positive and 30 negative) 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. A 

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BIOZEK Final 4.0 – June 1, 2021 
 
study personnel will collect demographics information from the 
subjects. 
 
A medical staff member will measure body surface temperature 
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 and/or FAM values will be 
requested. The Ct (cycle threshold) is defined as the number of 
cycles required for the fluorescent signal to cross the threshold 
(i.e., exceeds background level). The lower the Ct level the greater 
the amount of target nucleic acid in the sample. FAM (Fluorescein) 
the is most commonly used fluorescent dye attachment for 
oligonucleotides and is compatible with most fluorescent detection 
equipment.  
 
2.BIOZEK COVID-19 Antigen Rapid Test Cassette- 
Nasopharyngeal Swab 
(via self-collection - nasopharyngeal swab sample). 
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 included 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 Cassette- Oral Fluid 
 (via self-collection - oral fluid sample) 
Oral fluid sample 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 included 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. 
 
Results will be retrieved from the RT-PCR test when available and 
all three samples will be analyzed and compared.  
 
 
 
 
 
 
 
 
 
 
 
 

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BIOZEK Final 4.0 – June 1, 2021 
 
 
Criteria for Evaluation 
 
Safety Criteria:  
During self-collection, the subject will be closely monitored 
according to standard of care and any adverse events will be 
captured.  
 
Efficacy Criteria:  
Sensitivity and Specificity will be calculated separately for 
BIOZEK COVID-19 Antigen Rapid Test - on a self-collected, 
nasopharyngeal sample and for BIOZEK COVID-19 Antigen 
Rapid Test on the self-collected oral fluid sample. 
 
Additionally, the result of each test performed by the subject will 
be compared to the RT-PCR test result. 
 
End Points: 
 
Sensitivity and Specificity of BIOZEK COVID-19 Antigen Rapid 
Test on self-collected nasopharyngeal sample. 
 
Sensitivity and Specificity of BIOZEK COVID-19 Antigen Rapid 
Test on self-collected oral fluid sample. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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BIOZEK Final 4.0 – June 1, 2021 
 
Table of Contents 
1. Protocol Synopsis 
2 
2. Introduction 
6 
3. Background 
6 
4. Study Objectives: 
7 
5. Investigational Product 
7 
6. Study Population 
14 
6.1 Inclusion Criteria 
14 
6.2 Exclusion Criteria 
14 
6.3 Sample Size 
14 
6.4 Confirmation of Patient Enrollment 
14 
6.5 Patient Identification 
14 
6.6 Removal, Replacement, or Early Withdrawals of Subjects 
15 
7. Overview of Investigational Plan and Study Administration 
15 
7.1 Enrollment 
15 
7.2 Material and Methods 
15 
7.3 Premature Discontinuation 
16 
7.4 Protocol Violations 
16 
7.5 Compliance 
16 
8. Data analysis. 
17 
9. Ethics 
17 
9.1 Hospital Ethics Committee/Institutional Review Board 
17 
9.2 Ethical Conduct of the Study 
17 
9.3 Subject Information and Consent 
17 
10.References 
18 
 
 
 
 
 
 
 
 
 
 
 
 

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BIOZEK Final 4.0 – June 1, 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 Final 4.0 – June 1, 2021 
 
4. Study Objectives:  
_____________________________________________________________________________ 
 
To assess sensitivity and specificity of BIOZEK COVID-19 Antigen Rapid Test on a self-
collected sample and self-performed test by subject (nasopharyngeal swab and oral fluid). 
                                                 
To assess subject’s performance to collect samples and conduct BIOZEK COVID-19 Antigen 
Rapid Test. 
5. Investigational Product 
_____________________________________________________________________________ 
 
The BIOZEK COVID-19 Antigen Rapid Test Cassette is a qualitative membrane-based 
immunoassay for the detection of SARS-CoV-2 nucleocapsid protein antigens in human 
nasopharyngeal swab specimens and in oral fluid 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. 
 
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. 
 
 
Table.1 Amounts, concentrations, or quantities of antibodies in each test. 
 
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 

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BIOZEK Final 4.0 – June 1, 2021 
 
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. 
Materials provided in the BIOZEK-COVID-19 Antigen Rapid Test kit includes:  
Nasopharyngeal Swab: Test cassettes, Sterile Swabs, Extraction tubes and tips, Extraction 
Buffer, Workstation, Package Insert. 
 
 
 
 
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  
 
Oral Fluid: Test cassette, Collection Device (Funnel, Extraction Tube and Tip, Dropper), 
Extraction Buffer, Biosafety Bag, Workstation, Package Insert, Instruction for Use. 
 
 

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BIOZEK Final 4.0 – June 1, 2021 
 
 
 
 
 
Description of Test Steps:  
 
Biozek Covid-19 Antigen Rapid Test  
Specimen Collection - Nasopharyngeal Swab 
 
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.  
 
 
Nasal Swab Specimen Collection  
1. Insert a sterile swab less than one inch (about 2 cm) into a nostril (until resistance is met at the 
turbinate).  
2. Rotate the swab 5-10 times against the nasal wall. Using the same swab repeat the collection 
procedure with the second nostril.  
3. Withdraw the sterile swab, avoid excess volume and high-viscous nasal discharge.  

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BIOZEK Final 4.0 – June 1, 2021 
 
 
Caution: If the swab stick breaks during specimen collection, repeat specimen collection with a 
new swab.  
 
Specimen Extraction –Nasopharyngeal Swab 
Only the extraction buffer provided in this kit is to be used for specimen extraction.  
1. Peel off the sealing on the extraction tube with extraction buffer inside.  
2. Place the swab specimen into the extraction buffer, for better mixture and extraction to release 
the 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. Fit the tip onto the top of the extraction tube. Use extracted sample solution as 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. 
 
Testing Procedure – Nasopharyngeal Swab 
Allow the test cassette, extracted sample solution and/or controls to equilibrate to room 
temperature (15-30°C) prior to testing.  
1. 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.  
2. Shake the extracted sample solution to mix it well. Invert the sample extraction tube and add 3 
drops of the Extracted Sample Solution (approx.75-100μL) to the specimen well(S) of the 

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BIOZEK Final 4.0 – June 1, 2021 
 
cassette. Start the timer.  
3. Wait for the red line(s) to appear and read the result at 15 minutes. Do not interpret the result 
after 20 minutes. 
 
 
Interpretation of results - Nasopharyngeal Swab 
POSITIVE: * Two red lines appear. One red line should be in the control region (C) and another 
red line should be in the test region (T). Positive result in the test region indicates detection of 
COVID-19 antigens in the sample. *NOTE: Red color line intensity in the test region (T) will 
vary based on the amount of COVID-19 antigen 
present in the sample. Any shade of red color in the 
test region (T) should be considered positive.  
 
NEGATIVE: One red line appears in the control 
region (C). No apparent red line appears in the test 
region (T) indicates a negative COVID-19 antigen 
test result.  
 
INVALID: No red line appears in the control region 
(C). Insufficient specimen volume or incorrect 
procedural techniques are the most likely reasons for control line failure. Review the procedures 
and repeat the test with a new cassette. If the problem persists, discontinue using the test kit 
immediately and contact your local BIOZEK products distributor. 
 
 

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BIOZEK Final 4.0 – June 1, 2021 
 
 
Specimen Collection - Oral Fluid  
Advise the patient not to consume food, beverages, chewing gum, tobacco, and 
other substances at least 10 minutes prior to specimen collection.  
Step 1  
Connect the plastic tube (number 2) to the mouthpiece (number 1). Press the 
plastic tube as far as possible into the mouthpiece. 
 
Step 2  
If you are having trouble collecting saliva in your mouth, try closing your mouth and wiggling 
your tongue. Gently rubbing the outside of your cheeks, just behind your back teeth. Making 
chewing motions with your mouth.  
 
NOTE: We recommend carrying out this step in the morning. 
 
Step 3  
Spit the oral fluid into the mouthpiece. There should be about 0.5 ml of liquid in 
the plastic tube. This corresponds to the bottom line on the plastic tube. 
 
Step 4a  
Remove the mouthpiece (number 1) and dispose of it in the specimen bag 
(number 8). Place the plastic tube in the holder (number 6). 
 
Step 4b (only follow this step if there is too much saliva)  
More than 0.5 ml of liquid? Take the pipette (number 3). Press and hold the bulb 
until the pipette protrudes into the solution of the plastic tube (1). Release the 
balloon slowly, so that the pipette sucks up the solution (2). Bring the liquid level to 
the bottom line (0.5 ml). 
 
 
Specimen Extraction – Oral Fluid 
Step 5  
Take the buffer (number 4) and remove the seal at the top (by cutting/breaking it). 
Squeeze the contents of the buffer into the plastic tube (number 2) containing the 
mucus/spittle. 
 
Step 6  
Put the cap (number 5) on the plastic tube (number 2). 
 

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BIOZEK Final 4.0 – June 1, 2021 
 
 
 
Step 7 
Knead the bottom of the plastic tube firmly (number 2) for 10 seconds to mix the 
buffer well with the mucus/spit. 
 
 
Testing Procedure – Oral Fluid 
Step 8  
Tear open the test package and remove the test cassette. Turn the plastic tube 
(number 2) upside down and let 2 drops of liquid fall into the opening next to the 
letter S on the cassette (number 7). 
 
Step 9  
Wait 15 minutes.  
 
Step 10  
Read the result Positive: You have tested positive for COVID-19 antigens, so please contact your 
doctor. Negative: You have tested negative, so the test did not detect any antigens in your 
sample. However, if you have COVID-19 related complaints, please contact your doctor. Invalid: 
The test cannot be displayed, so contact your supplier for further instruction. Do not throw the 
test away. If necessary, take a Positive Negative Invalid photo of the contents and packaging. 
 
 
 
How to Store Biozek COVID-19 Antigen rapid test. 
Store the BIOZEK COVID-19 Antigen Rapid Test Cassette 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 Final 4.0 – June 1, 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. 
● Be capable of performing a self-collection of an oral fluid sample with use of oral fluid 
collection 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. 
● Cannot perform self-collection of an oral fluid sample with use of oral fluid collection 
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 on-site 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. 
 

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BIOZEK Final 4.0 – June 1, 2021 
 
6.6 Removal, Replacement, or Early Withdrawals of Subjects 
 
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 
 
The Enrollment population consists of up to 250 (minimum of 30 positive and 30 negative 
samples) symptomatic patients. Enrollment will take place at the subject’s home during 
scheduled visits to patients appointed for an RT-PCR test, as the standard of care procedure, 
performed by a medical staff member. Medical staff members will perform the RT-PCR test and 
the samples will be sent to A2Z Diagnostics Laboratory. The results will be available in 1-3 
days. Results including Ct and/or FAM values of the RT-PCR test from subjects enrolled to the 
study will be collected by study personnel. 
 
After completion of the RT-PCR Test, the patients will be asked if they are willing to participate 
in the BIOZEK Study. 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 personnel will collect demographics information from the subjects; in addition, they will 
take the subject’s body’s surface temperature and capture it in the CRF.  
 
Subject will perform 2 additional tests performed in a manner described below: 
 
1.BIOZEK COVID-19 Antigen Rapid Test Cassette-Nasopharyngeal Swab 
(via self-collection - nasopharyngeal swab sample),  
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 included 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.   
 
2. BIOZEK COVID-19 Antigen Rapid Test Cassette-Oral Fluid 
(via self-collection - oral fluid sample) 
Oral fluid sample 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 included with the 

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BIOZEK Final 4.0 – June 1, 2021 
 
test. The subject’s performance during self-collection and test performance will be monitored 
and recorded in a performance form. Results in 15 minutes 
 
Test Results  
 
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. 
 
Results will be retrieved from the PCR test when available and all three samples will be analyzed 
and 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.  
 
 
7.5 Compliance  
 
This study will be conducted in accordance with ICH-Good Clinical Practice guidelines.  
 
 
7.6 Risks  

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BIOZEK Final 4.0 – June 1, 2021 
 
 
During self-collection the subject will be closely monitored according to standard of care and 
any adverse effects will be documented.  
 
8. Data analysis 
_____________________________________________________________________________ 
 
The data will be collected and analyzed by Quality Research and Invention team. 
Results of RT-PCR, BIOZEK COVID-19 Antigen Rapid Test on self-collected nasopharyngeal 
sample and BIOZEK COVID-19 Antigen Rapid Test on self-collected oral fluid samples will be 
analyzed.  
Additionally, Ct and/or FAM 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. 
 
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 

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BIOZEK Final 4.0 – June 1, 2021 
 
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].