FDA COVID-19 Flu Antigen Self Test Instruction Manual

FDA COVID-19 Flu Antigen Self Test

Specifications:

• Product Name: QuickFinderTM COVID-19/Flu Antigen Self Test
• Intended Use: Qualitative detection and differentiation of SARS-CoV-2, Influenza A, and Influenza B protein antigens
• Age Requirement: Individuals aged 14 years or older for self-collected specimens, individuals two (2) years or older for adult-collected specimens
• Authorization: For non-prescription home use under Emergency Use Authorization (EUA)
• Specimen Type : Anterior nares nasal swabs only

Product Usage Instructions

1. Collection of Specimen:
   Ensure the individual is eligible for testing based on the age requirements mentioned above. Collect the nasal swab specimen from the individual’s anterior nares following the provided instructions.

2. Test Procedure:
   Open the test kit and remove the necessary components. Place the swab specimen in the provided buffer solution as per the instructions. Apply the required number of drops to the test device and wait for the specified time for results to develop.

3. Interpretation of Results:
   After 15 minutes, check the test device for the presence of coloured lines as per the provided guide. Interpret the results according to the presence or absence of specific lines for each antigen.

4. Result Analysis:
   Follow the guidelines provided in the user manual to determine the presence of SARS-CoV-2, Influenza A, and Influenza B antigens based on the test results.

INTENDED USE

• The QuickFinder™ COVID-19/Flu Antigen Self Test is a lateral flow immunoassay intended for the qualitative detection and differentiation of SARS-CoV-2, influenza A, and influenza B protein antigens.
• This test is authorized for non-prescription home use with self-collected anterior nares nasal swab specimens from individuals aged 14 years or older, or with adult-collected anterior nasal swab specimens from individuals two (2) years or older. This test is only authorized for individuals with signs and symptoms of respiratory infection consistent with COVID-19 within the first four (4) days of symptom onset when tested at least twice over three days with at least 48 hours between tests.
• Clinical signs and symptoms of respiratory viral infection due to SARS-CoV-2 and influenza can be similar.
• Results are for the simultaneous identification of SARS-CoV-2, influenza A, and influenza B virus protein antigens but do not differentiate between SARS-CoV and SARS-CoV-2 viruses and are not intended to detect influenza C antigens. The viral antigens targeted by this test are generally detectable from specimens collected using nasal swabs during the acute phase of infection. Positive results indicate the presence of viral antigens, but clinical correlation with patient history and other diagnostic information is necessary to determine infection status.
• Positive results do not rule out bacterial infection or co-infection with other viruses. The agent detected may not be the definitive cause of disease. Individuals who test positive with the QuickFinder™ COVID-19/Flu Antigen Self Test should self-isolate and seek follow-up care with their physician or healthcare provider as additional testing may be necessary.
• All negative results are presumptive and confirmation with a molecular assay, if necessary for patient management, may be performed. Negative results do not rule out SARS-CoV-2, Influenza A and Influenza B infection and should be used for the sole basis for treatment or patient management decisions, including infection control decisions such as isolating from others and wearing masks. Negative results should be considered in the context of an individual’s recent exposures, history and the presence of clinical signs and symptoms consistent with SARS-CoV-2, influenza A and influenza B infection.
• Individuals who test negative and continue to experience SARS-CoV-2 and/or influenza like symptoms of fever, cough, and/or shortness of breath may still have SARS-CoV-2 and/or influenza infection and should seek follow up care with their physician or healthcare provider.
• The QuickFinder™ COVID-19/Flu Antigen Self Test is only for use under the Food and Drug Administration’s Emergency Use Authorization.

SUMMARY AND EXPLANATION OF THE TEST

• The ongoing COVID-19 pandemic, along with other seasonally prevalent illnesses such as influenza (Flu), continue to be among the world’s most pressing healthcare issues. While contagious respiratory illnesses such as COVID-19 and influenza share similar symptoms and means of transmission, they are caused by different viruses. The Centers for Disease Control and Prevention (CDC) has also raised concerns about the potential co-infection with two or more of the respiratory viruses. There is an urgent need for rapid COVID-19 and Influenza A/B diagnostic over-the-counter tests so that patients can seek appropriate treatment with their healthcare provider before their symptoms worsen.
• The QuickFinder™ COVID-19/Flu Antigen Self Test is a rapid lateral flow test for the qualitative detection of the SARS-CoV-2, Influenza A and Influenza B using anterior nares nasal swab samples from those who are suspected of COVID-19, Influenza A and Influenza B. The QuickFinder™ COVID-19/Flu Antigen Self Test is validated for testing direct samples without transport media.
• The cassette contains membranes which are pre-coated with anti-SARS-CoV-2 nucleocapsid protein monoclonal antibodies, anti-influenza A nucleoprotein monoclonal antibodies and anti-influenza B nucleoprotein monoclonal antibodies on the test lines.
• Another anti-SARS-CoV-2 nucleocapsid protein monoclonal antibodies, anti-influenza A nucleoprotein monoclonal antibodies and anti-influenza B nucleoprotein monoclonal antibodies are each bound to the beads. When the sample is put into the sample well, the antibodies bound to the beads and the antigen in the sample bind to form complexes and migrate to the membrane. The complexes will be captured by coated antibodies on the membrane, and then the line will form a visible line. The presence of
• SARS-CoV-2, influenza A and influenza B antigens are indicated by lines visible in the S-marked position, A-marked position, and B-marked position in the results window, respectively.
• The results of the test are interpreted at 15 minutes. Refer to the Interpretation of Results section.

MATERIALS AND REAGENTS PROVIDED

The QuickFinder™ COVID-19/Flu Antigen Self Test is offered in a 1, 2, 4, 5 and 25 test/kit sizes. The kit configurations are provided below:

Number of Test/Kit| 1 Test/Kit| 2 Tests/Kit| 4 Tests/Kit| 5 Tests/Kit| 25 Tests/Kit
---|---|---|---|---|---
Test Cassette| 1| 2| 4| 5| 25
Sterile Swab| 1| 2| 4| 5| 25
Extraction Buffer Tube & Filter Cap| 1| 2| 4| 5| 25
Quick Reference Instructions (QRI)| 1| 1| 1| 1| 1

MATERIALS REQUIRED BUT NOT INCLUDED

• Materials required but not provided: A clock or timer
• Recommended materials: Disposable gloves and mask, if swabbing others.

WARNINGS, PRECAUTIONS, AND SAFETY INFORMATION

• Read all instructions carefully before performing the test. Failure to follow the instructions may result in inaccurate test results.
• For in vitro diagnostic use.
• In the USA, this product has not been FDA cleared or approved, but has been authorized by FDA under an Emergency Use Authorization. This product has been authorized only for the detection of proteins from SARS-CoV-2, influenza A and influenza B, not for any other viruses or pathogens. The emergency use of this product is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of COVID-19 under Section564(b)(1) of the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. §.360bbb-3(b)(1), unless the declaration if terminated or authorization is revoked sooner.
• Serial testing should be performed in individuals with COVID-19 negative results at least twice over three days (with 48 hours between tests) for symptomatic individuals. You may need to purchase additional tests to perform this serial testing.
• Consistent with serial testing recommendations for SARS-CoV-2, for multi-analyte tests, symptomatic individuals who test positive for influenza A or B on the initial test but test negative for SARS-CoV-2 should be tested again in 48 hours to evaluate for co-infection with SARS-CoV-2 infection.
• An anterior nasal swab sample can be self-collected by an individual age 14 years and older. Children age 2 to 13 years should be tested by an adult.
• Do not use on anyone under 2 years of age.
• Wear a safety mask or other face-covering when collecting a specimen from a child or another individual.
• Do not use if any of the test kit contents or packaging is damaged.
• Do not use the test after the expiration date shown on the external packaging.
• Use only components of this test kit.
• Ensure all kit components are at room temperature before use.
• Test components are single-use. Do not re-use.
• Do not touch the swab tip.
• Once opened, the test cassette should be used immediately.
• Do not read test results before 15 minutes or after 30 minutes. Results read before 15 minutes or after 30 minutes may lead to a false positive, false negative, or invalid result.
• Faint lines may appear on the test strip prior to running the test when tests are stored at hot or humid conditions. Do not read or interpret test results until after the sample has been added to the test cassette and the test has been allowed to run for 15 minutes.
• Faint blue lines can occur near the “A” position of the test strip with some Flu B samples at high viral loads. Only test lines that appear at both the correct position and in the correct color should be read and interpreted.
• Make sure there is sufficient light for testing. For best results, read test in a well-lit area.
• In the event of spillage, ensure that it is cleaned thoroughly using suitable disinfectant.
• Do not use any nasal sprays, gels or creams at least 30 minutes before you collect a nasal sample.
• The test sample must be collected from both nostrils with the same swab.
• Do not use on anyone who is prone to nosebleeds or has had facial injuries or head injuries/surgery in the past six months.
• Remove any piercings from nose before starting the test.
• To ensure accurate test results for Influenza B, avoid contamination with hand soap liquid gel.
• Dispose of unused contents and containers after use.
• Keep testing kit and kit components away from children and pets before and after use.
• Avoid contact with your skin, eyes, nose, or mouth. Do not ingest any kit components. The reagent solution contains harmful chemicals (see table in the next column). If the solution contacts your skin, eyes, nose, or mouth, flush with large amounts of water.

If irritation persists, seek medical advice: https://www.poison-help.org or 1- 800- 222-1222.

Hazard Category (Mixture)| GHS Hazard Statement for Mixture| Labeling of Harm(s)| Hazardous Ingredients (%)
---|---|---|---
3| Mild skin irritation| Causes mild skin irritation (H316)| Ÿ   Triton X-100 / 1%

Ÿ   Proclin 300 / 0.05%

2| Serious eye irritation| Causes serious eye irritation (H319)| Ÿ   Triton X-100 / 1%

Ÿ   Proclin 300 / 0.05%

QUALITY CONTROL

Internal Quality Control
Each QuickFinder™ COVID-19/Flu Antigen Self Test has a built-in internal procedural control. The red line appearing at the “C” position is an internal procedural control. This procedural control line indicates that sufficient flow has occurred, and the functional integrity of the test cassette has been maintained. A distinct red Control line should always appear if the test has been performed correctly. If the Control line does not appear, the test result is invalid, and a new test should be performed.

External Quality Control
External run controls are not required to use the QuickFinder™ COVID-19/Flu Antigen Self Test in a home setting.

TEST PROCEDURE

INTERPRETATION OF RESULTS

Test results are read and interpreted visually. Read result at 15-30 minutes with good lighting. Test results should not be read until after the sample has been added and the test has been allowed to run for 15 minutes, and only test lines that appear at the correct position and in the correct color should be read and interpreted.

Look at the result window and locate the letters C and S, B, A on the side of the window.
A red line should always appear at the C position; this is a control line and signal that the test is working properly. The information for each line is as follows:

• C = Control (red line)
• S = COVID-19 (SARS-CoV-2) (red line)
• B = Influenza B (blue line)
• A = Influenza A (red line)

Repeat testing is needed to improve test accuracy. Please follow the table below when interpreting test results. Results should be considered in the context of an individual’s recent exposures, history, and the presence of clinical signs and symptoms consistent with COVID-19, Flu A and Flu B.

POSITIVE (+)
If the control line at C is visible, and any other line or multiple lines on S, B and/or A appear, the test is positive.

IF THE TEST IS POSITIVE

• Repeat testing does not need to be performed if individuals have a positive result at any time.
• A positive test result means that the COVID-19, Flu A and/or Flu B virus(es) were detected in the sample, and tt is very likely the individual has the respective infection(s) and are contagious. Please contact the patient’s doctor/primary care physician (if applicable) and the local health authority immediately and instruct your patient to adhere to the local guidelines regarding self-isolation. There is a small chance that this test can give you a positive result that is incorrect (a false positive).
• Positive results do not rule out bacterial infection or co-infection with other viruses. The agent detected may not be the definite cause of disease. Individuals who test positive with the QuickFinder™ COVID-19/Flu Antigen Self Test should self-isolate and seek follow up care with their physician or healthcare provider as additional confirmatory testing with a molecular test for positive results may also be necessary, if there is a low likelihood of COVID-19, such as in individuals without known exposures to COVID-19 or residing in communities with low prevalence of infection.
• Report your test result(s) at MakeMyTestCount.Org – this voluntary and anonymous reporting helps public health teams understand COVID-19 spread in your area and across the country and informs public health decisions.

Note : The Test line may vary in shade and intensity (light or dark, weak, or strong). The intensity of the Control line should not be compared to that of the Test line for the interpretation of the test result.

NEGATIVE (-)
If the control line at “C” is visible and you do not see a line at ‘A’, ‘B’ or ‘S’, the test is negative.

To increase the chance that the negative result for COVID-19, Flu A and Flu B is accurate, you should test again in 48 hours if this is your first test and you have symptoms on the first day of testing.

IF THE TEST IS NEGATIVE
The virus that causes COVID-19, Flu A, and/or Flu B were not detected in the sample. A negative result does not rule out COVID-19, Flu A and/or Flu B. There is a higher chance of false negative results with antigen tests compared to laboratory-based molecular tests. If you tested negative and continue to experience COVID-19, Flu A and/or Flu B-like symptoms, you should seek follow- up care with your healthcare provider. All negative results should be treated as presumptive and confirmation with a molecular assay may be necessary if there is a high likelihood of SARS-CoV-2 infection, such as in an individual with a close contact with COVID-19 or with suspected exposure to COVID-19 or in communities with high prevalence of infection. Negative results do not rule out SARS-CoV 2 infection and should not be used as the sole basis for treatment or patient management decisions, including infection control decisions.

INVALID

• If a control line is not visible at “C” after 15 minutes, even if any other line is visible in the results window, THE TEST HAS FAILED and is considered invalid.
• If the test cassette looks like the examples below then the test result is invalid and you must repeat the test with a new swab sample, a new tube, and a new test cassette.

STORAGE AND STABILITY

QuickFinder™ COVID-19/Flu Antigen Self Test should be stored between 36 °F (2°C) to 86°F (30 °C).

LIMITATIONS

• The performance of this test was established based on the evaluation of a limited number of clinical specimens collected between October, 2023 to January, 2024, when omicron was the predominant SARS-CoV-2 strain. The clinical performance has not been established for all circulating variants but is anticipated to be reflective of the prevalent variants in circulation at the time and location of the clinical evaluation. Performance at the time of testing may vary depending on the variants circulating, including newly emerging strains of COVID-19 and influenza and their prevalence, which change over time.
• There is a higher chance of false negative results with antigen tests than with laboratory-based molecular tests due to the sensitivity of the test technology. This means that there is a higher chance this test will give a false negative result in an individual with COVID-19 and influenza as compared to a molecular test, especially in samples with low viral load.
• All COVID-19 and influenza antigen test negative results are presumptive and confirmation with a molecular assay may be necessary.
• If you continue to have symptoms consistent with COVID-19 and influenza, and both your first and second tests are negative, you may not have COVID-19 or influenza; however, you should follow-up with a healthcare provider.
• Based on sequence analysis, a potential for cross-reactivity between the SARSCoV-2 test and HKU1 exists. Wet testing for HKU1 coronavirus was not conducted and therefore, cross-reactivity between SARS-CoV-2 and HKU1 coronavirus cannot be ruled out.
• Liquid gel hand soap may cause false negative results with this test. Please ensure that hands are dry after washing prior to performing the test.
• If the test is positive, then proteins from the virus that causes COVID-19, Flu A and/or Flu B have been found in the sample and the individual likely has COVID-19, Flu A and/or Flu B.
• This test is read visually and has not been validated for use by those with impaired vision or color- impaired vision.
• Incorrect test results may occur if a specimen is incorrectly collected or handled.

PERFORMANCE CHARACTERISTICS

Analytical Performance

Limit of Detection (LoD) (Analytical Sensitivity)
The Limit of Detection (LoD) of the QuickFinder™ COVID-19/Flu Antigen Self Test was determined using serial dilutions of one strain of UV inactivated SARS-CoV-2 (USA-WA1/202) and two live strains of Influenza A and Influenza B. Contrived samples were prepared by spiking the strain into pooled human negative swab matrix (PNSM) obtained from healthy volunteers confirmed negative by RT-PCR. The preliminary LoD initially determined by testing ten- fold serial dilution series of three (3) replicates was confirmed by testing twenty (20) replicates. The confirmed LoD for the QuickFinder™ COVID-19/Flu Antigen Self Test is shown in the table below.

Virus Strains

| Stock Concentration

(TCID 50/mL)

| LoD   Concentration

(TCID 50/mL)

|

TCID 50/Swab

| # Positive/ #Total

Tested

| Percent Detected

(%)

---|---|---|---|---|---
SARS-CoV-2

(USA-WA1/2020)

| 3.16 x 106| 1.58 x 103| 7.90 x 101| 20/20| 100%
Influenza A H1N1pdm09:

A/Victoria/4897/2022

| 2.02 x 105| 2.02 x 102| 1.01 x 101| 20/20| 100%
Influenza A H3N2:

A/Darwin/6/2021

| 4.17 x 105| 2.09 x 102| 1.04 x 101| 20/20| 100%
Influenza B Victoria:

B/Washington/02/2019

| 3.16 x 106| 3.16 x 103| 1.58 x 102| 20/20| 100%
Influenza B Yamagata:

B/Florida/4/2006

| 1.17 x 105| 2.93 x 101| 1.46| 20/20| 100%

Analytical Reactivity
The QuickFinder™ COVID-19/Flu Antigen Self Test had wet testing (analytical reactivity) performed by establishing the LoD for Influenza A strains, Influenza B strains and SARS-CoV-2 strains on the QuickFinder™ COVID-19/Flu Antigen Self Test to determine if the device can detect target analytes across a variety of strains. A selection of temporal, geographic and genetically diverse Influenza strains were tested on the QuickFinder™ COVID-19/Flu Antigen Self Test for inclusivity. Individual virus strains were diluted in pooled negative swab matrix (PNSM) at 10-fold dilutions and tested in triplicate. PNSM, un-spiked, was tested in triplicate. After a 10-fold break point was established testing two-fold dilution points of the lowest positive ten-fold dilution was completed. The lowest 10-fold or 2-fold dilution that demonstrated three (3) positives replicates for each was identified.

Influenza A

(H1N2)

| A/Minnesota/19/2011| (H1N2)v| 8.00 x 106 CEID50/mL
Influenza A (H3N2)| A/Tasmania/503/2020| H3N2| 1.3 x 105 FFU/mL
A/New York/21/2020| H3N2| 3.3 x 105 FFU/mL
A/Alaska/01/2021| H3N2| 3.8 x 104 FFU/mL
A/Hong Kong/45/2019| H3N2| 3.8 x 104 FFU/mL
A/Hong Kong/2671/2019| H3N2| 1.1 x 103 TCID50/mL
A/Indiana/08/2011| (H3N2)v| 8.1 x 102 TCID50/mL
Influenza A

(H5N1)

| A/mallard/Wisconsin/2576/2009| H5N1| 4.00 x 106 CEID50/mL
Influenza A

(H7N3)

| A/northern

pintail/Illinois/10OS3959/2010

| H7N3| 2.80 x 106 CEID50/mL
Influenza B non-Victoria,

non-Yamagata

|

B/Maryland/1/1959

| Non-Victoria, non-Yamagata|

3.4 x 103 CEID50/mL

Influenza B Victoria lineage| B/Brisbane/60/2008| Victoria| 1.6 x100 TCID50/mL
B/Colorado/06/2017| Victoria| 2.9 x 101 TCID50/mL
B/Texas/02/2013| Victoria| 2.5 x 101 TCID50/mL
B/Michigan/01/2021| Victoria| 1.4 x 104 TCID50/mL
Influenza B Yamagata lineage| B/Texas/06/2011| Yamagata| 1.5 x 103 TCID50/mL
B/Utah/09/2014| Yamagata| 1.26 x 103 TCID50/mL
B/Wisconsin/01/2010| Yamagata| 1.78 x 102 TCID50/mL

Competitive Interference
Competitive interference testing (i.e., evaluation of potential for a high concentration of one targe virus to interfere with detection of a low concentration of another target virus) for the QuickFinder™ COVID-19/Flu Antigen Self Test was completed and no competitive interference across analytes was observed. The testing was performed with different combinations of low (3x LoD) and high concentrations (either 1000x LoD or the highest concentration achievable exceeding 105 PFU/mL, CEID50/mL or TCID50/mL) of live Influenza A, live Influenza B and UV inactivated SARS-CoV-2 on the QuickFinder™ COVID-19/Flu Antigen Self Test device to determine if the candidate device can detect target analytes across a variety of analyte concentrations.

Results

1| High| 3X LoD| Negative| Pass.

No competitive interference.

2| High| Negative| 3X LoD| Pass.

No competitive interference.

3| High| 3X LoD| 3X LoD| Pass.

No competitive interference.

4| 3X LoD| High| Negative| Pass.

No competitive interference.

5| Negative| High| 3X LoD| Pass.

No competitive interference.

6| 3X LoD| High| 3X LoD| Pass.

No competitive interference.

7| 3X LoD| Negative| High| Pass.

No competitive interference.

8| Negative| 3X LoD| High| Pass.

No competitive interference.

9| 3X LoD| 3X LoD| High| Pass.

No competitive interference.

High-dose hook effect
No high dose hook effect was observed when tested with up to a concentration below with the QuickFinder™ COVID-19/Flu Antigen Self Test.

TCID50/mL
Influenza B Yamagata lineage| B/Florida/04/2006| Yamagata| 1.17 x 105 TCID50/mL

Analytical Specificity:

• Cross-reactivity and microbial interference
  Cross-reactivity and microbial interference studies were performed with related pathogens, high prevalence disease agents, and normal or pathogenic flora that are reasonably likely to be encountered in the clinical specimens of the nasal cavity. Each organism was tested with and without the presence of UV inactivated SARS-CoV-2, live Influenza A, and Influenza B viruses at 3X co- spike equivalency LoD.

• Cross reactivity:
  For cross reactivity, each organism was tested in replicate of three (3) at the concentrations listed in the following table of results. All testing samples were prepared in the pooled nasal wash (PNW). No cross reactivity or interference was observed for any of the organisms tested.

IDI

|

Organism

|

Concentration

| Influenza A Test Results (Positive/

Total)

| Influenza B Test Results (Positive/

Total)

| SARS-CoV-2

Test Results

(Positive/

Total)

---|---|---|---|---|---
229E| Human coronavirus 229E| 1.58E+05 TCID50/mL| 0/3| 0/3| 0/3
OC43| Human coronavirus OC43| 7.00E+05 TCID50/mL| 0/3| 0/3| 0/3
NL63| Human coronavirus NL63| 7.05E+04 TCID50/mL| 0/3| 0/3| 0/3
SARS| SARS-coronavirus| 1.25E+05 PFU/mL| 0/3| 0/3| 0/3
MERS| MERS-coronavirus| 1.47E+05 TCID50/mL| 0/3| 0/3| 0/3
AV1| Adenovirus Type 1| 2.23E+05 TCID50/mL| 0/3| 0/3| 0/3
AV7| Adenovirus Type 7| 1.58E+05 TCID50/mL| 0/3| 0/3| 0/3
hMPV| Human metapneumovirus 4

Type B2

| 3.50E+05 TCID50/mL| 0/3| 0/3| 0/3
P1| Parainfluenza virus 1| 2.00E+05 TCID50/mL| 0/3| 0/3| 0/3
P2| Parainfluenza virus 2| 1.75E+05 TCID50/mL| 0/3| 0/3| 0/3
P3| Parainfluenza virus 3| 7.00E+05 TCID50/mL| 0/3| 0/3| 0/3
P4| Parainfluenza virus 4b| 2.39E+05 TCID50/mL| 0/3| 0/3| 0/3
EV68| Enterovirus 68| 2.23E+05 TCID50/mL| 0/3| 0/3| 0/3
RSVA| Respiratory syncytial virus A| 3.50E+05 TCID50/mL| 0/3| 0/3| 0/3
RSVB| Respiratory syncytial virus B| 2.29E+05 TCID50/mL| 0/3| 0/3| 0/3
RV| Rhinovirus| 7.05E+04 TCID50/mL| 0/3| 0/3| 0/3
HI| Haemophilus influenzae| 9.68E+06 CFU/mL| 0/3| 0/3| 0/3
SPN| Streptococcus pneumonia| 1.81E+07 CFU/mL| 0/3| 0/3| 0/3
SPY| Streptococcus pyogenes| 7.50E+07 CFU/mL| 0/3| 0/3| 0/3
CA| Candida albicans| 1.21E+07 CFU/mL| 0/3| 0/3| 0/3
BP| Bordetella pertussis| 2.90E+08 CFU/mL| 0/3| 0/3| 0/3
MP| Mycoplasma pneumonia| 2.50E+07 CFU/mL| 0/3| 0/3| 0/3
CP| Chlamydia pneumoniae| 4.33E+06 IFU/mL| 0/3| 0/3| 0/3
LP| Legionella pneumophila| 6.50E+06 CFU/mL| 0/3| 0/3| 0/3
MT| Mycobacterium tuberculosis| 3.03E+06 CFU/mL| 0/3| 0/3| 0/3
PJ| P. jiroveci-S. cerevisiae| 1.30E+07 CFU/mL| 0/3| 0/3| 0/3
SA| Staphylococcus aureus subsp .

aureus

| 2.60E+08 CFU/mL| 0/3| 0/3| 0/3
SE| Staphylococcus epidermidis| 9.00E+07 CFU/mL| 0/3| 0/3| 0/3
CX| Corynebacterium xerosis| 2.30E+07 CFU/mL| 0/3| 0/3| 0/3
EC| Escherichia coli| 1.79E+08 CFU/mL| 0/3| 0/3| 0/3
LA| Lactobacillus Acidophilus| 1.21E+07 CFU/mL| 0/3| 0/3| 0/3
MC| Moraxella catarrhalis| 2.50E+08 CFU/mL| 0/3| 0/3| 0/3
NM| Neisseria meningitidis| 3.43E+06 CFU/mL| 0/3| 0/3| 0/3
NE| Neisseria Elongata| 2.68E+08 CFU/mL| 0/3| 0/3| 0/3
PA| Pseudomonas aeruginosa| 3.45E+08 CFU/mL| 0/3| 0/3| 0/3
SS| Streptococcus salivarius| 1.01E+06 CFU/mL| 0/3| 0/3| 0/3
ME| Measles| 8.48E+05 TCID50/mL| 0/3| 0/3| 0/3
MU| Mumps| 8.48E+05 TCID50/mL| 0/3| 0/3| 0/3

IDI

|

Organism

|

Concentration

| Influenza A Test Results (Positive/

Total)

| Influenza B Test Results (Positive/

Total)

| SARS-CoV-2

Test Results

(Positive/

Total)

---|---|---|---|---|---
EBV| Epstein Barr Virus| 1.83E+06 CP/mL| 0/3| 0/3| 0/3
CMV| Cytomegalovirus| 7.05E+04 TCID50/mL| 0/3| 0/3| 0/3

Microbial interference:
For evaluating microbial interference against the SARS-CoV-2, Influenza A (H1N1pdm09),
Influenza B (Yamagata) test lines, the organisms were tested with SARS-CoV-2 UV-inactivated SARS-CoV-2: USA-WA1/2020 (ZeptoMetrix # 0810587UV), Live Flu A: H1N1pdm09/A/Victoria/4897/2022 (ZeptoMetrix# 0810684CF), Live Flu B: Yamagata/B/Florida/4/2006 (ZeptoMetrix # 0810255CF) diluted to 3x LoD concentration in negative pooled nasal wash (PNW). No microbial interference was seen with the organisms tested at the concentrations shown below.

IDI

|

Organism

|

Concentration

| Influenza A Test Results (Positive/ Total)| Influenza B Test Results (Positive/ Total)| SARS-CoV-2

Test Results (Positive/ Total)

---|---|---|---|---|---
229E| Human coronavirus 229E| 1.58E+05 TCID50/mL| 3/3| 3/3| 3/3
OC43| Human coronavirus OC43| 7.00E+05 TCID50/mL| 3/3| 3/3| 3/3
NL63| Human coronavirus NL63| 7.05E+04 TCID50/mL| 3/3| 3/3| 3/3
SARS| SARS-coronavirus| 1.25E+05 PFU/mL| 3/3| 3/3| 3/3
MERS| MERS-coronavirus| 1.47E+05 TCID50/mL| 3/3| 3/3| 3/3
AV1| Adenovirus Type 1| 2.23E+05 TCID50/mL| 3/3| 3/3| 3/3
AV7| Adenovirus Type 7| 1.58E+05 TCID50/mL| 3/3| 3/3| 3/3
hMPV| Human metapneumovirus 4

Type B2

| 3.50E+05 TCID50/mL| 3/3| 3/3| 3/3
P1| Parainfluenza virus 1| 2.00E+05 TCID50/mL| 3/3| 3/3| 3/3
P2| Parainfluenza virus 2| 1.75E+05 TCID50/mL| 3/3| 3/3| 3/3
P3| Parainfluenza virus 3| 7.00E+05 TCID50/mL| 3/3| 3/3| 3/3
P4| Parainfluenza virus 4b| 2.39E+05 TCID50/mL| 3/3| 3/3| 3/3
EV68| Enterovirus 68| 2.23E+05 TCID50/mL| 3/3| 3/3| 3/3
RSVA| Respiratory syncytial virus A| 3.50E+05 TCID50/mL| 3/3| 3/3| 3/3
RSVB| Respiratory syncytial virus B| 2.29E+05 TCID50/mL| 3/3| 3/3| 3/3
RV| Rhinovirus 1A| 7.05E+04 TCID50/mL| 3/3| 3/3| 3/3
HI| Haemophilus influenzae| 9.68E+06 CFU/mL| 3/3| 3/3| 3/3
SPN| Streptococcus pneumonia| 1.81E+07 CFU/mL| 3/3| 3/3| 3/3
SPY| Streptococcus pyogenes| 7.50E+07 CFU/mL| 3/3| 3/3| 3/3
CA| Candida albicans| 1.21E+07 CFU/mL| 3/3| 3/3| 3/3
BP| Bordetella pertussis| 2.90E+08 CFU/mL| 3/3| 3/3| 3/3
MP| Mycoplasma pneumonia| 2.50E+07 CFU/mL| 3/3| 3/3| 3/3
CP| Chlamydia pneumoniae| 4.33E+06 IFU/mL| 3/3| 3/3| 3/3

IDI

|

Organism

|

Concentration

| Influenza A Test Results (Positive/ Total)| Influenza B Test Results (Positive/ Total)| SARS-CoV-2

Test Results (Positive/ Total)

---|---|---|---|---|---
LP| Legionella pneumophila| 6.50E+06 CFU/mL| 3/3| 3/3| 3/3
MT| Mycobacterium tuberculosis| 3.03E+06 CFU/mL| 3/3| 3/3| 3/3
PJ| P. jiroveci-S. cerevisiae| 1.30E+07 CFU/mL| 3/3| 3/3| 3/3
SA| Staphylococcus aureus subsp .

aureus

| 2.60E+08 CFU/mL| 3/3| 3/3| 3/3
SE| Staphylococcus epidermidis| 9.00E+07 CFU/mL| 3/3| 3/3| 3/3
CX| Corynebacterium xerosis| 2.30E+07 CFU/mL| 3/3| 3/3| 3/3
EC| Escherichia coli| 1.79E+08 CFU/mL| 3/3| 3/3| 3/3
LA| Lactobacillus acidophilus| 1.21E+07 CFU/mL| 3/3| 3/3| 3/3
MC| Moraxella catarrhalis| 2.50E+08 CFU/mL| 3/3| 3/3| 3/3
NM| Neisseria meningitidis| 3.43E+06 CFU/mL| 3/3| 3/3| 3/3
NE| Neisseria elongata| 2.68E+08 CFU/mL| 3/3| 3/3| 3/3
PA| Pseudomonas aeruginosa| 3.45E+08 CFU/mL| 3/3| 3/3| 3/3
SS| Streptococcus salivarius| 1.01E+06 CFU/mL| 3/3| 3/3| 3/3
ME| Measles| 8.48E+05 TCID50/mL| 3/3| 3/3| 3/3
MU| Mumps| 8.48E+05 TCID50/mL| 3/3| 3/3| 3/3
EBV| Epstein Barr Virus| 1.83E+06 CP/mL| 3/3| 3/3| 3/3
CMV| Cytomegalovirus| 7.05E+04 TCID50/mL| 3/3| 3/3| 3/3
PNW| Pooled Negative Nasal Wash| N/A| 3/3| 3/3| 3/3

Endogenous/Exogenous Interfering Substances
The QuickFinder™ COVID-19/Flu Antigen Self Test was evaluated for performance in the presence of potentially interfering substances that might be present in a respiratory specimen. The positive (3x LoD co-spike PNW with UV inactivated SARS-CoV-2, and live Influenza A and B) and negative specimens were tested with the addition of the potentially interfering substances. Each substance was tested in replicates of three (3). The performance of the QuickFinder™ COVID-19/Flu Antigen Self Test was not affected by any of the potentially interfering substances listed in the table below at the concentrations noted.

Substance| Concentration| Interference

(Yes/No)

---|---|---
Human Whole Blood (EDTA tube)| 4% v/v| No
Mucin (porcine stomach, type II)| 0.5%| No
Chloraseptic (Menthol/Benzocaine)| 1.5 mg/mL| No
Naso GEL (NeilMed)| 5% v/v| No
Nasal Drops (Phenylephrine)| 15% v/v| No
Nasal Spray (Oxymetazoline)| 15% v/v| No
Nasal Spray (Cromolyn)| 15% v/v| No
Zicam| 5% v/v| No
Substance| Concentration| Interference

(Yes/No)

---|---|---
Homeopathic (Alkalol)| 10% v/v| No
Sore Throat Phenol Spray| 15% v/v| No
Tobramycin| 4 μg/mL| No
Mupirocin| 10 mg/mL| No
Fluticasone Propionate| 5% v/v| No
Tamiflu (Oseltamivir Phosphate)| 5 mg/mL| No
FluMist/FluMist Quadrivalent Live intranasal influenza virus vaccine| 15% v/v| No
Zanamivir| 282 ng/mL| No
Biotin| 3,500 ng/mL| No
Body and Hand Lotion| 0.5% w/v| No
Body Lotion with 1.2% dimethicone| 0.5% w/v| No
Hand Lotion| 5% w/v| No
Hand Sanitizer with Aloe, 62% ethyl alcohol| 5% v/v| No
Hand Sanitizer with cream lotion| 15% v/v| No
Hand Sanitizer, 80% ethanol, fast drying| 15% v/v| No
Hand soap liquid gel*| 0.05% w/v| No

CLINICAL EVALUATION

A prospective clinical study was completed at six (6) sites in the United States for clinical validation of the QuickFinder™ COVID-19/Flu Antigen Self Test for the detection of SARS-CoV-2, Influenza A and/or Influenza B in subject-collected anterior nasal swab (ANS) samples. The study evaluated the QuickFinder™ COVID-19/Flu Antigen Self Test performance in symptomatic individuals (those suspected of COVID-19, Influenza A and/or Influenza B). A total of 608 symptomatic subjects were enrolled who were currently experiencing symptoms associated with COVID-19, Influenza A and/or Influenza B. Each enrolled subject either self-collected one sample from their anterior nasal passages (from both nostrils), or had one sample collected from him/her by another individual. Each of the subjects also had an ANS sample (from both nostrils) collected from him/her by one of the study personnel. Test results from the QuickFinder™ COVID-19/Flu Antigen Self Test were compared to highly sensitive molecular FDA cleared SARS-CoV-2, Influenza A, and Influenza B RT- PCR assays. Out of 608 enrolled subjects, there were 577 evaluable subjects. Of the 577 evaluable subjects for SARS-CoV-2, the analysis resulted in a positive percent agreement (PPA) of 88.7%(95% CI: 81.2%-93.4%) and negative percent agreement (NPA) of 99.6% (95% CI: 98.5%-99.9%). There were 577 evaluable subjects for Influenza A, the analysis resulted in a PPA of 88.5% (95% CI: 77.0% – 94.6%) and a NPA of 98.9% (95% CI: 97.5% -99.5%). There were 577 evaluable subjects for Influenza B, the analysis resulted in a PPA of 85.4% (95% CI: 71.6% – 93.1%) and a NPA of 99.6% (95% CI: 98.6% to 99.9%).

SARS-CoV-2 Primary Analysis

SARS-CoV-2

| Comparator Positives| Comparator Negatives| ****

Total

---|---|---|---
QuickFinder™ COVID-19/Flu Antigen Self Test Positives| ****

94

| ****

2

| ****

96

QuickFinder™ COVID-19/Flu Antigen Self Test Negatives| ****

12

| ****

469

| ****

481

Total| 106| 471| 577

• Positive Percent Agreement (94/106) = 88.7% (95% CI: 81.2%-93.4%)
• Negative Percent Agreement (469/471) = 99.6% (95% CI: 98.5% – 99.9%)

Positive Results Broken Down by Days Since Symptom Onset for SARS-CoV-2

Days post COVID-19

Symptoms

Onset

| Number of Subject samples tested| QuickFinder™ COVID-19/Flu

Antigen Self Test

Positives

| ****

Comparator Positives

| ****

% Positive Rate (by Comparator)

| ****

PPA

---|---|---|---|---|---
0| 11| 0| 0| 0.0%| NA
1| 137| 23| 27| 19.7%| 85.2%
2| 224| 35| 41| 18.3%| 85.4%
3| 126| 26| 27| 21.4%| 96.3%
4| 79| 10| 11| 13.9%| 90.9%
Total| 577| **94*| 106| 18.4%| 88.7%**

(95% CI: 81.2% -93.4%)

• NOTE : Two false positive subjects were excluded from the QuickFinder™ COVID-19/Flu Antigen Self Test Positives count for the purposes of this table.

Influenza A Primary Analysis

Influenza A

| Comparator Positives| Comparator Negatives| ****

Total

---|---|---|---
QuickFinder™ COVID-19/Flu Antigen Self Test Positives| ****

46

| ****

6

| ****

52

QuickFinder™ COVID-19/Flu Antigen Self Test Negatives| ****

6

| ****

519

| ****

525

Total| 52| 525| 577
Positive Percent Agreement (46/52) = 88.5% (95% CI: 77.0%-94.6%)

Negative Percent Agreement (519/525) = 98.9% (95% CI: 97.5% – 99.5%)

Influenza B Primary Analysis

Influenza B

| Comparator Positives| Comparator Negatives| ****

Total

---|---|---|---
QuickFinder™ COVID-19/Flu Antigen Self Test Positives| ****

35

| ****

2

| ****

37

QuickFinder™ COVID-19/Flu Antigen Self Test Negatives| ****

6

| ****

534

| ****

540

Total| 41| 536| 577
Positive Percent Agreement (35/41) = 85.4% (95% CI: 71.6%-93.1%)

Negative Percent Agreement (534/536) = 99.6% (95% CI: 98.6% – 99.9%)

 | Subjects (by lay-user collection and testing

(N=86)

| Self-collecting and testing (N=491)| ****

Overall (N=577)

---|---|---|---
Mean (SD)| 12.0 (13.5)| 36.7 (15.8)| 33 (17.8)
Median [Min, Max]| 10 [2, 74]| 33 [14, 80]| 29 [2, 80]
Age Group
≥2-<14 years of age| 79 (91.9%)| 0 (0.0%)| 79 (13.7%)
14-24 years of age| 2 (2.3%)| 145 (29.5%)| 147 (25.5%)

24-64 years of age| 1 (1.2%)| 313 (63.7%)| 314 (54.4%)
≥65 years of age| 4 (4.7%)| 33 (6.7%)| 37 (6.4%)
Sex at Birth
Female| 34 (39.5%)| 300 (61.1%)| 334 (57.9%)
Male| 52 (60.5%)| 191 (38.9%)| 243 (42.1%)
Ethnicity
Hispanic/Latino| 4 (4.7%)| 87 (17.7%)| 91 (15.8%)
Not Hispanic/Latino| 82 (95.3%)| 404 (82.3%)| 486 (84.2%)
Race
American Indian or Alaskan Native| 0 (0.0%)| 0 (0.0%)| 0 (0.0%)
Asian| 0 (0.0%)| 11 (2.2%)| 11 (1.9%)
Black or African American| 4 (4.7%)| 38 (7.7%)| 42 (7.3%)
Native Hawaiian/Pacific Islander| 0 (0.0%)| 5 (1.0%)| 5 (0.9%)
White| 77 (89.5%)| 428 (87.2%)| 505 (87.5%)
Unknown/Prefer not to answer| 0 (0.0%)| 2 (0.4%)| 2 (0.3%)
Other (Mixed race/biracial)| 5 (5.8%)| 7 (1.4%)| 12 (2.1%)

SERIAL TESTING

• A prospective clinical study was conducted between January 2021 and May 2022 as a component of the Rapid Acceleration of Diagnostics (RADx) initiative from the National Institutes of Health (NIH). A total of A total of 7,361 individuals were enrolled via a decentralized clinical study design, with a broad geographical – 13 – representation of the United States. Per inclusion criteria, all individuals were asymptomatic upon enrollment in the study and at least 14 days prior to it and did not have a SARS-CoV-2 infection in the three months prior to enrollment. Participants were assigned to one of three EUA authorized SARS CoV- 2 OTC rapid antigen tests to conduct serial testing (every 48 hours) for 15 days. If an antigen test was positive, the serial-antigen testing result is considered positive.
• At each rapid antigen testing time point, study subjects also collected a nasal swab for comparator testing using a home collection kit (using a 15-minute normalization window between swabs). SARS-CoV-2 infection status was determined by a composite comparator method on the day of the first antigen test, using at least two highly sensitive EUA RT-PCRs. If results of the first two molecular test were discordant a third highly sensitive EUA RT-PCR test was performed, and the final test result was based upon the majority rule.
• Study participants reported symptom status throughout the study using the MyDataHelps app. Two-day serial antigen testing is defined as performing two antigen tests 36 – 48 hours apart. Three-day serial antigen testing is defined as performing three antigen tests over five days with at least 48 hours between each test.
• Out of the 7,361 participants enrolled in the study, 5,609 were eligible for analysis. Among eligible participants, 154 tested positive for SARS-CoV-2 infection based on RT-PCR, of which 97 (62%) were asymptomatic on the first day of their infection, whereas 57 (39%) reported symptoms on the first day of infection.
• Performance of the antigen test with serial testing in symptomatic individuals is described in the table below. Data establishing PPA of COVID-19 antigen serial testing compared to molecular comparator single day testing throughout the course of infection with serial testing. Data is from all antigen tests in the study combined.
• Data establishing PPA of COVID-19 antigen serial testing compared to molecular comparator single day testing throughout the course of infection with serial testing. Data is for all antigen tests in study combined.

__

Days After First PCF Positive Test Result

| Symptomatic on First Day of Testing
---|---
Antigen Positive/PCR Positive (Antigen Test Performance % PPA)
1 Test| 2 Test| 3 Test
0| 34/57 (59.6%)| 47/51 (92.2%)| 44/47 (93.6%)
2| 58/62 (93.5%)| 59/60 (98.1%)| 43/43 (100.0%)
4| 55/58 (94.8%)| 53/54 (98.1%)| 39/40 (97.5%)
6| 27/34 (79.4%)| 26/33 (78.8%)| 22/27 (81.5%)
8| 12/17 (70.6%)| 12/17 (70.6%)| 7/11 (63.6%)
10| 4/9 (44.4%)| 3/7 (42.9%)| N/A

1. Test = one (1) test performance on the noted days after first PCR positive test result. Day 0 is the first day of documented infection with SARS-CoV-2.
2. Tests = two (2) tests performance an average of 48 hours apart. The first test performed on the indicated day and the second test performed 48 hours apart.
3. Tests = three (3) tests performance an average of 48 hours apart. The first test performed on the indicated date, the second test performed 48 hours later, and a final test performed 48 hours after the second test.

CUSTOMER SUPPORT

For questions, or to report a problem, please call Technical Support at 844-760-0556. (Available Hours: Mon. to Fri.: 9 a.m. – 5 p.m. PST) or covidhometest@osangllc.com .
Test system problems may also be reported to the FDA using the MedWatch reporting system.(phone: 1-800 FDA-1088; fax: 1-800 FDA-1078: or http://www.fda.gov/medwatch).

Manufactured for OSANG LLC 215 N Marengo Ave. 3rd Fl Pasadena, CA 91101

Manufacturing site:
OSANG Healthcare Co., Ltd. 132, Anyangcheondong-ro, Dongan-gu, Anyang-si, Gyeonggi-do, 14040, South Korea NEXUS DX, INC. 6759 Mesa Ridge Road San Diego, CA 92121

SYMBOLS USED ON THE PRODUCT LABELS The table below describes the symbols on the QuickFinder™ COVID-19 Antigen Self Test package.

FAQ

Q: Can this test differentiate between SARS-CoV and SARS-CoV-2 viruses?
A: No, this test does not differentiate between SARS-CoV and SARS-CoV-2 viruses.

Q: How long should I wait for results after performing the test?
A: Results should be interpreted after 15 minutes of performing the test.

References

• MakeMyTestCount
• Coronavirus Disease 2019 (COVID-19) | CDC
• MedWatch: The FDA Safety Information and Adverse Event Reporting Program | FDA

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