C-Sync COV9712A COVID-19 Antigen Test Instructions

COV9712A COVID-19 Antigen Test
Instructions

For use under the Emergency Use Authorization (EUA) only.
For in vitro diagnostic use.
For prescription use only.

Quick Reference Instructions

Read the complete IFU prior to performing a test.
INTENDED USE TM The C-Sync COVID-19 Antigen Test is a lateral flow immunoassay intended for the qualitative detection of nucleocapsid protein and spike protein antigens from SARS-CoV-2 in direct anterior nasal swab specimens collected from individuals who are suspected of COVID-19 by their healthcare provider within the first seven (7) days of symptoms onset, when tested at least twice over three days with at least 48 hours between tests, and from individuals without symptoms or other epidemiological reasons to suspect COVID-19, when tested at least three times over five days with at least 48 hours between tests.

Testing is limited to laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, that meet the requirements to perform moderate, high or waived complexity tests. This product is authorized for use at the Point of Care (POC), i.e., in patient care settings operating under a CLIA Certificate of Waiver, Certificate of Compliance, or Certificate of Accreditation. The C-Sync TM COVID-19 Antigen Test does not differentiate between SARS-CoV-1 or SARS- CoV-2 viruses.

Results are for the identification of SARS-CoV-2 nucleocapsid and spike protein antigens, which are generally detectable in anterior nasal swab specimens 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 fully determine infection status. Positive results do not rule out bacterial infection or coinfection with other viruses. The agent detected may not be the 1definitive cause of disease.

Laboratories within the United States and its territories are required to report all results to the appropriate public health authorities.
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 infection and should not be used as the sole basis for treatment or patient management decisions, including infection control measures 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 COVID-19.

The C-Sync TM COVID-19 Antigen Test is intended for use by healthcare professionals or operators who are proficient in performing tests in point of care settings. The C-Sync TM COVID-19 Antigen Test is only for use under the Food and Drug Administration’s Emergency Use Authorization. This product has not been FDA cleared or approved.

MATERIALS AND SUPPLIES PROVIDED
The C-Sync™ COVID-19 Antigen test kits are available with 20 tests per kit including the following components:

• 20 Test cassettes individually packaged in a foil pouch with a desiccant
• 20 Extraction buffer tubes with dropper cap.
• 20 Sterile Nasal Swabs for sample collection
• 20 Instructions for Use (IFU)
• 1 Quick Reference Instructions.

MATERIALS REQUIRED BUT NOT PROVIDED

• External Positive and Negative Quality Controls sold separately – Bio Synchronicity Product Catalog Number: COV9712AC available at www.biosynchroni
• Personal Protective Equipment per local recommendations
• Timer
• Tube rack for specimens

STORAGE AND STABILITY

• Store the kit between 2°C to 30°C (36°F to 86°F).
• Avoid direct exposure to sunlight.
• Do not freeze the content of the kit.
• The shelf life of the kit is indicated on the outer package.
• Do not use the test kit beyond its expiration date.
• The test device must remain in the sealed pouch until use.

TEST PROCEDURE

A. TEST PREPARATION

1. Do not use past the expiration on the label.
2. Wear appropriate personal protective equipment and gloves when handling patient samples and running the test.
3. Allow the kit components to reach a temperature between 15°C – 30°C (59°F-86°F) prior to testing.
4. Remove a C-Sync TM test from a pouch. Place the C-Sync™ Test Cassette on a flat and clean surface for the entire duration of test operation.

Remove a nasal swab from the package.

Insert the entire collection tip of the swab provided (usually ½ to ¾ of an inch, or 1 to 1.5 cm) inside the nostril.

Gently, but firmly, collect a sample from the nasal wall by slowly rotating the swab into a circular path against the nasal wall at least 4 times for a total of 15 seconds. Be sure to collect any drainage that may be present on the swab. Slowly remove the swab.

Using the same swab, repeat the same sample collection process in the other nostril.

If immediate testing is not possible, and to maintain the best performance and avoid possible contamination, it is highly recommended the nasal swab specimen be placed in a clean, unused plastic tube and capped tightly at room temperature (15°C-30°C / 59°F-86°F) for up to (1) hour prior to testing. Ensure the swab fits securely within the tube and the cap is tightly closed. If greater than 1 hour delay occurs, dispose of the sample. A new sample must be collected for testing.
C. SPECIMEN PREPARATION PROCEDURE
Remove the cap from the extraction buffer vial by squeezing the top of the vial and by lifting the cap upwards on the handle of the cap.

Carefully insert the swab inside the vial and plunge it to the bottom. Rotate the swab against the wall of the vial for 10 seconds.

Tightly squeeze and release the bottom of the vial against the absorbent part of the swab. This will make the liquid buffer inside the vial rise and fall. Make sure the buffer rises and falls to fully cover and wash the absorbent part of the swab. Twirl the swab while squeezing and washing the swab with the buffer. Repeat this squeezing and twirling technique 5 times.

Stop squeezing the bottom of the vial and rotate the swab against the wall of the vial for 10 seconds.

Remove the swab slowly while squeezing tightly the top part of the vial against the absorbent part of the swab to extract as much liquid as possible from the swab with the goal of drying the swab. Firmly place the dropper cap attached to the vial onto the top of the vial. Make sure the dropper cap is securely in place.

D. SPECIMEN TESTING

Set the timer at 10 minutes, but do not start yet. eze here Invert the extraction vial and squeeze the ridge area of the vial to dispense 4 drops, drop by drop, into the sample well of the C-Sync TM Test Cassette. Tap the device if the specimen fluid appears viscous when dropping the buffer into the sample well to aid in the wicking process. well Apply only 4 drops to the sample well. Erroneous results may occur if less/more than 4 drops are applied.
Start the timer for 10 minutes. A visual observation of the red/purple dye entering the evaluation window of the test within 10 to 15 seconds after the test timer has been started shows the test is progressing. The test must be read within 10 minutes, as indicated below in Reading and Interpretation of Results

Do not read test results before 10 minutes or after 15 minutes. Erroneous results occur when reading before 10 minutes or after 15 minutes.
E. READING AND INTERPRETATION OF RESULTS
After dispensing the drops in the sample well, the results will be available as follows:
Positive:

If the Control line (C-line) is red/purple within 10 minutes and the Test line (T-line) is visible within 10 minutes, the test is positive. The color intensity of the Test line (T-line) will depend on the amount of SARS-Cov-2 nucleocapsid protein antigen in the sample. Any very faint colored Test line (T-line) should be considered positive. Tests should not be interpreted past 15 minutes.
Negative:

If the Control line (C-line) is red/purple at 10 minutes, and the Test line (T-line) is not visible at 10 minutes, the test is negative.
Invalid:

If the Control line (C-line) is not visible at 10 minutes, and regardless if the Test line (T-line) is visible or not visible, the test is invalid. Discard the test.
A new test should be repeated.
Do not interpret the results before 10 minutes. Results read after 15 minutes may be invalid.
Repeat testing is needed to improve test accuracy. Please follow the table below when interpreting test results for COVID-19.

Status on First Day of Testing| First Result Day 1| Second Result Day 3| Third Result Day 5| Interpretation
---|---|---|---|---
With Symptoms| Positive| N/A| N/A| Positive for COVID-19
Negative| Positive| N/A| Positive for COVID-19
Negative| Negative| N/A| Negative for COVID-19
Without Symptoms| Positive| N/A| N/A| Positive for COVID-19
Negative| Positive| N/A| Positive for COVID-19
Negative| Negative| Positive| Positive for COVID-19
Negative| Negative| Negative| Negative for COVID-19

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.

POSITIVE RESULT
The presence of both the control line © and test line (T) indicates the presence of SARS-CoV-2 antigen. The result suggests current SARS-CoV-2 infection. Samples with low levels of antigen may produce a faint test line. Any visible test line is considered positive. A positive test result means that the virus that causes COVID-19 was detected in the sample, and it is very likely the individual has COVID-19 and is 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 very small chance that this test can give 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 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 COVID19, such as in individuals without known exposures to COVID-19 or residing in communities with low prevalence of infection.

NEGATIVE RESULT
The presence of the red-colored control line (C) and no visible test line (T) indicates that SARS-CoV-2 antigen was not detected. To increase the chance that the negative result for COVID-19 is accurate, you should:

• If the individual has symptoms on the first day of testing, test again at least twice over three days with at least 48 hours between tests.
• If the individual does not have symptoms on the first day of testing, and from individuals without, test again at least three times over five days with at least 48 hours between tests.

A negative test result indicates that the virus that causes COVID-19 was not detected in the sample. A negative result does not rule out COVID-19. There is a higher chance of false negative results with antigen tests compared to laboratory-based tests such as PCR tests. If the test is negative but COVID19-like symptoms, e.g., fever, cough, and/or shortness of breath continue, follow up testing for SARSCoV-2 with a molecular test or testing for other respiratory disease should be considered. If applicable, seek follow up care with the primary health care 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 RESULT
If the red-colored control line (C) is not visible, DO NOT interpret the test result. The result is invalid regardless of the appearance of the test line. Collect a new nasal swab sample and repeat the assay with a new test

EXTERNAL QUALITY CONTROLS
External Quality Controls are available from Bio Synchronicity Corporation, Bio Synchronicity Product Catalog reference: COV9712AC, available at www.biosynchronicity.com
It is recommended that positive and negative external quality controls be run once with every new lot, every shipment, every new user, or in accordance with Local, State, and Federal regulations, or accreditation requirements.

EMERGENCY USE AUTHORIZATION – WARNING AND PRECAUTIONS
In the USA, this product has not been FDA cleared or approved; but has been authorized by FDA under an EUA for use by authorized laboratories; use by laboratories certified under the CLIA, 42 U.S.C. §263a, that meet requirements to perform moderate, high or waived complexity tests. This product is authorized for use at the Point of Care (POC), i.e., in patient care settings operating under a CLIA Certificate of Waiver, Certificate of Compliance, or Certificate of Accreditation. This product has been authorized only to be used with the C-SyncTM COVID-19 Antigen Test for the detection of proteins from SARS-CoV-2, not for any other viruses or pathogens. In the USA, 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 the virus that causes COVID-19 under Section 564(b)(1) of the Federal Food, Drug and Cosmetic Act, 21 U.S.C. § 360bbb-3(b)(1), unless the declaration is terminated or authorization is revoked sooner.

SUPPORT
For more information, please visit www.biosynchronicity.com
If you have any questions, contact customer service at: Email: support@biosynchronicity.com Phone: +1 425-898-3431

INDEX OF SYMBOLS

| Manufacturer
---|---
| CE mark
| Contains sufficient for test
| Store between 2°C and 30°C
**IVD**| In Vitro Diagnostic device
| Date of manufacture
| Keep dry
| Consult Instructions for Use
| Do not reuse
| Do not use if package is damaged
| Use by date
| Catalog Number
| Lot Number
| Keep away from sunlight
| For prescription use only

Bio Synchronicity Corporation
12835 Bel Red Rd, Suite 327
Bellevue, WA, 98005, USA
Email: support@biosynchronicity.com
www.biosynchronicity.com
COV9712A

For use under the Emergency Use Authorization (EUA) only.
For in vitro diagnostic use.
For prescription use only.

Instructions for Use Read

Read the complete IFU prior to performing a test.
INTENDED USE
COVID-19 Antigen Test is a lateral flow immunoassay intended for the qualitative detection of nucleocapsid protein and spike protein antigens from SARS-CoV-2 in direct anterior nasal swab specimens collected from individuals who are suspected of COVID-19 by their healthcare provider within the first seven (7) days of symptoms onset, when tested at least twice over three days with at least 48 hours between tests, and from individuals without symptoms or other epidemiological reasons to suspect COVID-19, when tested at least three times over five days with at least 48 hours between tests.
Testing is limited to laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, that meet the requirements to perform moderate, high or waived complexity tests. This product is authorized for use at the Point of Care (POC), i.e., in patient care settings operating under a CLIA Certificate of Waiver, Certificate of Compliance, or Certificate of Accreditation.
The C-Sync COVID-19 Antigen Test does not differentiate between SARS CoV or SARS-CoV-2 viruses.
TM Results are for the identification of SARS-CoV-2 nucleocapsid and spike protein antigens, which are generally detectable in anterior nasal swab specimens 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 fully determine infection status. Positive results do not rule out bacterial infection or coinfection with other viruses. The agent detected may not be the 1definitive cause of disease. Laboratories within the United States and its territories are required to report all results to the appropriate public health authorities.

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 infection and should not be used as the sole basis for treatment or patient management decisions, including infection control measures such as isolating from others and wearing masks. Negative results should be considered in the context of a individual’s recent exposures, history, and the presence of clinical signs and symptoms consistent with COVID-19.
COVID-19 Antigen Test is intended for use by healthcare professionals or operators who are proficient performing tests in point of care settings. The C-Sync The C-Sync TM COVID-19 Antigen Test is only for use under the Fog and Drug Administration’s Emergency Use Authorization. This product has not been FDA cleared approved.

SUMMARY AND EXPLANATION OF THE TEST
SARS-CoV-2 is a highly contagious virus which emerged at the end of 2019 and is spread primarily through respiratory particles. The C-Sync™ COVID-19 Antigen Test is a visually read rapid lateral flow immunoassay for the qualitative detection of SARS-CoV-2 directly from nasal swabs, without Viral Transport Media (VTM). Results are available in less than 10 minutes, making it a valuable evaluation tool for use in Point of Care.

PRINCIPLES OF THE TEST
The C-Sync™ COVID-19 Antigen Test is a lateral flow immunochromatographic assay for the detection of nucleocapsid and/or spike protein antigens specific to SARS-CoV-2 in nasal swab specimens, directly collected from individuals with or without symptoms, as described in the intended use. SARS-CoV-2 specific antibodies and a control protein are immobilized onto a membrane support as two distinct lines and combined with other reagents/pads to construct a test strip encased in a plastic cassette with a sample well. An anterior nasal swab sample collected from the patient is eluted into a vial with an extraction buffer and four drops are added to the sample well. The sample flows along the membrane. Test results are interpreted at 10 minutes. A red/purple Test (T) line and a Control (C) line appearing on the test strip, indicates that SARS-CoV-2 antigen was detected. The presence of one colored line at the C line indicates that SARS-CoV-2 antigen was not detected. No appearance of a colored line at the C line indicates an invalid test.

MATERIALS AND SUPPLIES PROVIDED
The C-Sync™ COVID-19 Antigen test kits are available with 20 tests per kit including the followingcomponents:

• 20 Test cassettes individually packaged in a foil pouch with a desiccant
• 20 Extraction buffer tubes with dropper cap.
• 20 Sterile Nasal Swabs for sample collection
• 20 Instructions for Use (IFU)
• 1 Quick Reference Instructions.

MATERIALS REQUIRED BUT NOT PROVIDED

• External Positive and Negative Quality Controls sold separately
  – BioSynchronicity Product Catalog Number: COV9712AC, available at www.biosynchronicity.com

• Personal Protective Equipment per local recommendations

• Timer

• Tube rack for specimens

WARNINGS AND PRECAUTIONS

• Read all instructions carefully before performing the test. Failure to follow the instructions may result in inaccurate test results.
• For prescription and in vitro diagnostic use only.
• In the USA, 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 diagnostic tests for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Act, 21 U.S.C. § 360bbb3(b)(1), unless the declaration is terminated or authorization is revoked sooner.
• This product has not been FDA cleared or approved, but has been authorized by FDA under an EUA for use by authorized laboratories; use by laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C §263a, that meet the requirements to perform moderate, high, or waived complexity tests. This product is authorized for use at the Point of Care (POC), i.e., in patient care settings operating under a CLIA Certificate of Waiver, Certificate of Compliance, or Certificate of Accreditation.
• Serial testing should be performed in individuals with negative results at least twice over three days (with 48 hours between tests) for symptomatic individuals and three times over five days (with at least 48 hours between tests) for asymptomatic individuals. You may need to purchase additional tests to perform this serial (repeat) testing.
• If the individual has symptoms longer than 7 days, you should consider testing at least three times over five days with at least 48 hours between tests.
• Federal Law restricts this test to sale by or on the order of a licensed practitioner (U.S. only).
• This product has been authorized only for the detection of proteins from SARS-CoV-2, not for any other viruses or pathogens.
• Laboratories within the United States and its territories are required to report all results to the appropriate public health laboratories.
• Do not use the test kit if the cassette pouch is damaged or improperly sealed.
• Do not use the test kit beyond expiration date printed on the outer package.
• Do not open the test cassette pouch until just before use. Once opened, the test card should be used immediately.
• Do not read test results before 10 minutes or after 15 minutes. Results before 10 minutes or after 15 minutes may lead to a false positive, false negative, or invalid result.
• Use only the components supplied with the kit.
• Swabs, vials, and tests are single use only. Do not re-use test components.
• Freshly collected specimens must be tested within an hour.
• Do not interchange the kit components from different lots.
• Inadequate specimen collection can adversely affect results.
• Do not store or test specimens in viral transport media.
• Temperature extremes and high humidity can adversely affect results.
• Wear appropriate personal protection equipment and gloves when running each test and handling patient specimens. Change gloves between handling of specimens suspected of COVID-19.
• Dispose of test cassette and materials as biohazardous waste in accordance with federal, state, and local requirements.
• Keep testing kit and kit components away from children and pets before and after use. Avoid contact with your [e.g., skin, eyes, nose, or mouth]. Do not ingest any kit components. The reagent solution contains harmful chemicals (see table below). If the solution contacts your [e.g., skin, eyes, nose, or mouth], flush with large amounts of water. If irritation persists, seek medical advice: https://www.poisonhelp.org or 1-800-222-1222.

Hazardous Ingredient for the Reagent Solution

Chemical Name| Harms (GHS) code for each ingredient| Concentration
Triton X-100| H302 Acute oral toxicity H315 Skin irritation
H318 Serious eye damage
H400 Short-term (acute) aquatic hazard H410 Long-term (chronic) aquatic hazard| 1%

For more information on EUAs please visit: https://www.fda.gov/emergency- preparednessand-response/mcm-legal-regulatory-and-policy-framework/emergency- use-authorization
For the most up to date information on COVID-19, please visit: www.cdc.gov/COVID-19
STORAGE AND STABILITY
Store the kit between 2°C to 30°C (36°F to 86°F).

• Avoid direct exposure to sunlight.
• Do not freeze the content of the kit.
• The shelf life of the kit is indicated on the outer package.
• Do not use the test kit beyond its expiration date.
• The test device must remain in the sealed pouch until use.

QUALITY CONTROL
A built-in control in each test cassette acts as an internal procedural control for the test and is needed to assess if the test is working properly. The appearance of a red/purple Control line (C-line) is used to confirm sufficient flow of the sample along the membrane has occurred and the functional integrity of the test has been maintained. If the Control line does not develop within 10 minutes, the test is considered invalid and should be discarded. Retesting with a new cassette is recommended. If the expected results are not obtained, do not perform a test and contact technical support.

EXTERNAL QUALITY CONTROLS
External Quality controls, required to demonstrate the integrity of the cassette and to ensure the reagents and the assay procedure are working properly, are not included in the C-Sync™ COVID-19 Antigen Test kit but are available from Bio Synchronicity Corporation. The External Quality Control kit is composed of one Negative Control and one Positive Control, each made of a lyophilized powder. The Positive Control contains noninfectious recombinant SARS-CoV-2 nucleocapsid protein antigen. It is recommended that positive and negative external quality controls be run once with every new lot, every shipment, every new user, or in accordance with Local, State, and Federal regulations, or accreditation requirements.

TEST PROCEDURE
A. TEST PREPARATION

1. Allow the kit components to reach a temperature between 15°C – 30°C (59°F – 86°F) prior to testing.
2. Remove a C-Sync™ test from a pouch. Place the C-Sync™ Test Cassette on a flat and clean surface, for the entire duration of test operation.

B. SPECIMEN COLLECTION PROCEDURE
Remove a nasal swab from the package.

Insert the entire collection tip of the swab provided (usually ½ to ¾ of an inch, or 1 to 1.5 cm) inside the nostril.

Gently but firmly, collect a sample from the nasal wall by slowly rotating the swab into a circular path against the nasal wall at least 4 times for a total of 15 seconds. Be sure to collect any drainage that may be present on the swab. Slowly remove the swab.

Using the same swab, repeat the same sample collection process in the other nostril.

If immediate testing is not possible, and to maintain the best performance and avoid possible contamination, it is highly recommended the nasal swab specimen be placed in a clean, unused plastic tube and capped tightly at room temperature (15°C-30°C) for up to (1) hour prior to testing. Ensure the swab fits securely within the tube and the cap is tightly closed. If greater than 1 hour delay occurs, dispose of the sample. A new sample must be collected for testing.

C. SPECIMEN PREPARATION PROCEDURE
Remove the cap from the extraction buffer vial by squeezing the top of the vial and by lifting the cap upwards on the handle of the cap.

Carefully insert the swab inside the vial and plunge it to the bottom. Rotate the swab against the wall of the vial for 10 seconds.

Tightly squeeze and release the bottom of the vial against the absorbent part of the swab. This will make the liquid buffer inside the vial rise and fall. Make sure the buffer rises and falls to fully cover and wash the absorbent part of the swab. Twirl the swab while squeezing and washing the swab with the buffer. Repeat this squeezing and twirling technique 5 times.

Stop squeezing the bottom of the vial and rotate the swab against the wall of the vial for 10 seconds.

Remove the swab slowly while squeezing tightly the top part of the vial against the absorbent part of the swab to extract as much liquid as possible from the swab with the goal of drying the swab. Firmly place the dropper cap attached to the vial onto the top of the vial. Make sure the dropper cap is securely in place.

D. SPECIMEN TESTING

Set the timer at 10 minutes, but do not start yet. Invert the extraction vial and squeeze the ridge area of the vial to dispense 4 drops, drop by drop, into the sample well of the C-Sync TM Test Cassette. Tap the device if the specimen fluid appears viscous when dropping the buffer into the sample well to aid in the wicking process.
Apply only 4 drops to the sample well. Erroneous results 1 may occur if less/more than 4 drops are applied.

Start the timer for 10 minutes. A visual observation of the red/purple dye entering the evaluation window of the test within 10 to 15 seconds after the test timer has been started shows the test is progressing. The test must be read within 10 minutes, as indicated below in Reading and Interpretation of Results.
Do not read test results before 10 minutes or after 15 minutes. Erroneous results may occur when reading before 10 minutes or after 15 minutes.

E. READING AND INTERPRETATION OF RESULTS
After dispensing the drops in the sample well, the results will be available as follows:
Positive:

If the Control line (C-line) is red/purple within 10 minutes and the Test line (T-line) is visible within 10 minutes, the test is positive. The color intensity of the Test line (T-line) will depend on the amount of SARS-Cov-2 nucleocapsid and/or spike protein antigens in the sample. Any very faint colored Test line (T-line) should be considered positive. Tests should not be interpreted past 15 minutes.
Negative:

If the Control line (C-line) is red/purple at 10 minutes, and the Test line (T-line) is not visible at 10 minutes, the test is negative.
Invalid:

If the Control line (C-line) is not visible at 10 minutes, and regardless if the Test line (T-line) is visible or not visible, the test is invalid. Discard the test. A new test should be repeated.
Do not interpret the results before 10 minutes. Results read after 15 minutes may be invalid.
Repeat testing is needed to improve test accuracy. Please follow the table below when interpreting test results for COVID-19.

Status on First
Day of Testing| First Result Day 1| Second Result Day 3| Third Result Day 5| Interpretation
---|---|---|---|---
With Symptoms| Positive| N/A| N/A| Positive for COVID-19
Negative| Positive| N/A| Positive for COVID-19
Negative| Negative| N/A| Negative for COVID-19
Without Symptoms| Positive| N/A| N/A| Positive for COVID-19
Negative| Positive| N/A| Positive for COVID-19
Negative| Negative| Positive| Positive for COVID-19
Negative| Negative| Negative| Negative for COVID-19

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.

POSITIVE RESULT
The presence of both the control line © and test line (T) indicates the presence of SARS-CoV-2 antigen. The result suggests current SARS-CoV-2 infection. Samples with low  levels of antigen may produce a faint test line. Any visible test line is considered positive.
Repeat testing does not need to be performed if patients have a positive result at any time.
A positive test result means that the virus that causes COVID-19 was detected in the sample, and it is very likely the individual has COVID-19 and is 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 very small chance that this test can  give 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 definitive cause of disease. Individuals who test positive 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

NEGATIVE RESULT
The presence of the red-colored control line (C) and no visible test line (T) indicates that SARS-CoV-2 antigen was not detected. To increase the chance that the negative result for COVID-19 is accurate, you should:

• If the individual has symptoms on the first day of testing, test again at least twice over three days with at least 48 hours between tests.
• If the individual does not have symptoms on the first day of testing, and from individuals without, test again at least three times over five days with at least 48 hours between tests.

A negative test result indicates that the virus that causes COVID-19 was not detected in the sample. A negative result does not rule out COVID-19. There is a higher chance of false negative results with antigen tests compared to laboratory-based tests such as PCR tests. If the test is negative but COVID- 19like symptoms, e.g., fever, cough, and/or shortness of breath continue, follow up testing for SARS-CoV-2 with a molecular test or testing for other respiratory disease should be considered. If applicable, seek follow up care with the primary health care 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 RESULT
If the red-colored control line (C) is not visible, DO NOT interpret the test result. The result is invalid regardless of the appearance of the test line. Collect a new anterior nasal swab sample and repeat the assay with a new test.

LIMITATIONS

• Test results should be correlated with the clinical history, epidemiological data and other data available to the clinician evaluating the patient.
• The performance of the C-Sync™ COVID-19 Antigen test was evaluated using the procedures provided in this Instructions for Use. Failure to follow the Instructions for Use may adversely affect the performance of the test and invalidate the results of the test.
• This is a qualitative test and the test does not provide information on the viral concentration present in the specimen.
• Positive results do not differentiate between SARS-CoV-1 and SARS-CoV-2.
• Positive test results do not rule out co-infections with other pathogens.
• All COVID-19 antigen test negative results are presumptive and confirmation with a molecular assay may be necessary.
• False negative results may occur if the concentration of the SARS-CoV-2 antigen in the clinical specimen is below the limit of detection of the test or if the sample was collected improperly.
• False negative results may occur if specimens are tested beyond 1 hour after collection.
• The performance of this test has not yet been evaluated in asymptomatic individuals.
• The performance of this test was established based on the evaluation of a limited number of clinical specimens collected between October 22, 2021 and January 24, 2022. Clinical performance has not been established with 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 SARS-CoV-2 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 as compared to a molecular test, especially in samples with low viral load.
• This test is read visually and has not been validated for use by those with impaired vision or color  impaired vision.
• Positive and negative predictive values are highly dependent on prevalence. False-negative test results are more likely during peak activity when the prevalence of the disease is high. False positive results are more likely during the periods of low SARS-CoV-2 activity when prevalence is moderate to low.
• If the patient continues to have symptoms of COVID-19, and both the patient’s first and second tests are negative, the patient may not have COVID-19, however additional follow-up may be needed.
• If the test is positive, then proteins from the virus that causes COVID-19 have been found in the sample and the individual likely has COVID-19.
• This test detects both viable (live) and nonviable SARS-CoV-2. Test performance depends on the amount of virus (antigens) in the sample and may or may not correlate with viral culture results performed on the same sample.

CONDITIONS of AUTHORIZATION for LABORATORY and PATIENT CARE SETTINGS
The C-Sync™ COVID-19 Antigen Test Letter of Authorization, along with the authorized Fact Sheet for Healthcare Providers, the authorized Fact Sheet for Patients, and authorized labeling are available on the FDA website:
https://www.fda.gov/medical-devices/coronavirus-disease2019-covid-19 -emergency-useauthorizations-medical-devices/in-vitro-diagnostics-euas.
However, to assist clinical laboratories using the C-Sync™ COVID-19 Antigen Test (“your product” in the conditions below), the relevant Conditions of Authorization are listed below.

A. Authorized laboratories 1 using your product must include with test result reports, all authorized Fact Sheets. Under exigent circumstances, other appropriate methods for disseminating these Fact Sheets may be used, which may include mass media.
B. Authorized laboratories using your product must use your product as outlined in the authorized labeling. Deviations from the authorized procedures, including the authorized instruments, authorized extraction methods, authorized clinical specimen types, authorized control materials, authorized other ancillary reagents and authorized materials required to use your product are not permitted.
C. Authorized laboratories that receive your product must notify the relevant public health authorities of their intent to run your product prior to initiating testing.
D. Authorized laboratories using your product must have a process in place for reporting test results to healthcare providers and relevant public health authorities, as appropriate. E. Authorized laboratories must collect information on the performance of your product and report to DMD/OHT7/OPEQ/CDRH (via email: CDRH-EUAReporting@fda.hhs.gov) and BioSynchronicity Corporation Support (via email: support@biosynchronicity.com or via phone by contacting BioSynchronicity Corporation technical support at +1 425-898-3431) any suspected occurrence of false positive or false negative results and significant deviations from the established performance characteristics of your product of which they become aware.
F. All operators using your product must be appropriately trained in performing and interpreting the results of your product, use appropriate personal protective equipment when handling this kit, and use your product in accordance with the authorized labeling.
G. BioSynchronicity Corporation authorized distributors, and authorized laboratories using your product must ensure that any records associated with this EUA are maintained until otherwise notified by FDA. Such records will be made available to FDA for inspection upon request.

1The letter of authorization refers to, “Laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, that meet the requirements to perform moderate, high or waived complexity tests. This test is authorized for use at the Point of Care (POC), i.e., in patient care settings operating under a CLIA Certificate of Waiver, Certificate of Compliance, or Certificate of Accreditation” as “authorized laboratories.”

PERFORMANCE CHARACTERISTICS
Clinical Performance The clinical performance of the C-Sync™ COVID-19 Antigen Test was evaluated in an enrichment study conducted in 2 different locations of Ochsner Health Campus, New Orleans, between October 2021 and June 2022. A total of 85 direct paired anterior nasal swabs from patients suspected of COVID-19 within the first seven days of symptom onset were randomly and blindly collected by 5 operators representing intended healthcare provider operators. The C-Sync™ COVID-19 Antigen Test results were compared to an FDA authorized RT-PCR comparator assay according to the FDA Reference Panel to determine the test performance.

Performance of the C-Sync™ COVID-19 Antigen Test in subjects within 7 days of symptoms.

• Of the 5 false negative results observed, 3 specimens were found to be negative on a second RT-PCR comparator  method (i.e., agreeing with the C-Sync™ test results); 2 specimens were found to be positive on a second RT-PCR  comparator method.
  Of the 1 false positive result observed, subsequent sequencing of this specimen confirmed it was positive.
  Demographics**

Clinical Performance (Asymptomatic Population)
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 7,361 individuals were enrolled via a decentralized clinical study design, with a broad geographical 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 SARSCoV-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). SARSCoV-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 My Data Helps 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. Pre-symptomatic subjects were included in the positive percent agreement (PPA) of asymptomatic individuals, if they were asymptomatic on the first day of antigen testing, regardless of whether they developed symptoms at any time after the first day of testing.
Performance of the antigen test with serial testing in individuals is described in the following table.
Data establishing PPA of COVID-19 antigen serial testing compared to the molecular comparator single  day testing throughout the course of infection with serial testing. Data is from all antigen tests in study combined.

DAYS AFTER FIRST PCR POSITIVE TEST RESULT| ASYMPTOMATIC ON FIRST DAY OF TESTING| SYMPTOMATIC ON FIRST DAY OF TESTING
---|---|---
Ag Positive / PCR Positive (Antigen Test Performance % PPA)
1 Test| 2 Tests| 3 Tests| 1 Test| 2 Tests| 3 Tests
0| 9/97| 35/89| 44/78| 34/57| 47/51| 44/47
(9.3%)| (39.3%)| (56.4%)| (59.6%)| (92.2%)| (93.6%)
2| 17/34| 23/34| 25/32| 58/62| 59/60| 43/43
(50.0%)| (67.6%)| (78.1%)| (93.5%)| (98.3%)| (100%)
4| 16/21| 15/20| 13/15| 55/58| 53/54| 39/40
(76.2%)| (75.0%)| (86.7%)| (94.8%)| (98.1%)| (97.5%)
6| 20/28| 21/27| 16/18| 27/34| 26/33| 22/27
(71.4%)| (77.8%)| (88.9%)| (79.4%)| (78.8%)| (81.5%)
8| 13/23| 13/22| 4/11| 12/17| 12/17| 7/11
(56.5%)| (59.1%)| (36.4%)| (70.6%)| (70.6%)| (63.6%)
10| 5/9| 5/8| | 4/9| 3/7|
(55.6%)| (62.5%)| (44.4%)| (42.9%)
1 Test = one (1) test performed 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 performed an average of 48 hours apart. The first test performed on the indicated day and the second test performed 48 hours later.
3 Tests = three (3) tests performance an average of 48 hours apart. The first test performed on the indicated day, the second test performed 48 hours later, and a final test performed 48 hours after the second test.

Limit of Detection (LoD)
A limit of detection (LoD) study was conducted to determine the lowest concentration of inactivated SARS-CoV-2 virus spiked into pooled human negative NP swab matrix at which 95% of all tested replicates were positive with the C-Sync™ COVID-19 Antigen Test. The LoD of the C-Sync™ COVID-19 Antigen Test in natural NP swab matrix was determined and confirmed to be 2.29×103 TCID50/mL or 1.15×102 TCID50/swab.

Endogenous Interfering Substances COVID-19 Antigen Test to determine if the substances that are naturally present in respiratory specimens or that may be artificially introduced into the nasal cavity cross react or interfere with the C-Sync The following (14) endogenous substances were evaluated with the C-Sync TM COVID-19 Antigen Test. Based on the results of this study, none of the endogenous substances cross react or interfere with the C-Sync TM COVID-19 Antigen Test. TM

Cross Reactivity and Microbial Interference
The Cross-reactivity and potential interference of the C-Sync™ COVID-19 Antigen Test were evaluated by testing microorganisms that may exist within the nasal cavity (16 viruses, 10 bacteria/fungal organisms and pooled human nasal wash). Each of the organisms was tested in triplicate in the absence or presence of UV inactivated SARS-CoV-2 virus (6.87×10 3 TCID50/mL). No cross- reactivity or interference was seen with the following microorganisms when tested at the concentrations presented in the table below.

| Potential Cross Reactant| Concentration Tested for Cross Reactivity| Concentration Tested for Interference
---|---|---|---
Virus| Adenovirus Serotype 5,| 1.6×108 TCID50/mL| 0.8×108 TCID50/mL
Enterovirus 71/Tainan/4643/98| 1.6×107 TCID50/mL| 0.8×107 TCID50/mL
Human coronavirus 229E| 1.6×105 TCID50/mL| 3.2×105 TCID50/mL
Human coronavirus OC43| 8.9×103 TCID50/mL| 4.45×104 TCID50/mL
Human coronavirus NL63| 1.6×104 TCID50/mL| 0.8×105 TCID50/mL
Human Metapneumovirus (hMPV) TN/91-320| 1.6×105 TCID50/mL| 3.2×105 TCID50/mL
Influenza A/Puerto Rico/8 MC/1934 (H1N1)| 2.8×108 TCID50/mL| 1.4×108 TCID50/mL
Influenza A/Brisbane/10/2007 (H3N2)| 2.2×107 TCID50/mL| 1.1×107 TCID50/mL
Influenza B/Florida/4/2006| 1.6×108 TCID50/mL| 0.8×108 TCID50/mL
MERS-Coronavirus EMC/2012, Irradiated lysate| 8.9×104 TCID50/mL| 2.97×105 TCID50/mL
Human Parainfluenza Virus 1, Strain HPIV1/FRA/29221106/2009| 8.9×105 TCID50/mL| 4.45×105 TCID50/mL
Human Parainfluenza Virus 2, Greer| 8.9×104 TCID50/mL| 2.97×105 TCID50/mL
Human Parainfluenza Virus 3, NIH 47885| 1.6×106 TCID50/mL| 0.8×106 TCID50/mL
Human Parainfluenza Virus 4A, M-25| 1.6×103 TCID50/mL| 0.8×104 TCID50/mL
Human respiratory syncytial virus, Strain A1998/3-2| 1.6×105 TCID50/mL| 3.2×105 TCID50/mL
Rhinovirus 40 strain 1794 (NIAID V-125-002-021)| 1.6×105 TCID50/mL| 3.2×105 TCID50/mL
Bacteria| Bordetella pertussis A639| 6.43×108 CFU/mL| 3.21×108 CFU/mL
Herophilus influenza Type B: Eagan| 1.35×108 CFU/mL| 0.67×108 CFU/mL
Chlamydophila pneumoniae| 9.16×106 CFU/mL| 4.55×106 CFU/mL
Legionella pneumophila Philadelphia| 1.91×109 CFU/mL| 0.95×109 CFU/mL
Mycoplasma pneumoniae M129| 2.7×107 CFU/mL| 1.35×107 CFU/mL
Staphylococcus aureus MRSA| 3.5×108 CFU/mL| 1.75×108 CFU/mL
Staphylococcus epidermidis| 2.9×107 CFU/mL| 1.45×107 CFU/mL
Streptococcus pneumoniae STREP2| 1.0×107 CFU/mL| 0.5×107 CFU/mL
Streptococcus pyogenes ABC020060016| 5.0×107 CFU/mL| 2.5×107 CFU/mL
Yeast| Candida albicans| 2.0×109 CFU/mL| 1.0×109 CFU/ml
NP| Pooled Nasal Wash| N/a| N/a

In Silico Study: The Basic Local Alignment Search Tool (BLAST) managed by the National Center for Biotechnology Information (NCBI) was used to assess the degree of nucleocapsid protein and spike protein sequence homology between SARS-CoV-2 and microorganisms not available for wet testing.

Human Coronavirus HKU1

• The human coronavirus HKU1 nucleocapsid protein showed 36.7% homology across 82% of the SARS-CoV-2 nucleocapsid protein sequence which is relatively low. But crossreactivity cannot be ruled out.
• The human coronavirus HKU1 spike protein showed 34.2 % homology across 70.3 % of the SARS-CoV-2 spike protein sequence, which is relatively low. But cross-reactivity cannot be ruled out.

SARS-CoV-1

• The homology between the SARS-CoV-2 and SARS-CoV-1 nucleocapsid proteins is high, at 90.5% across 100% of the sequence, therefore cross-reactivity is likely.
• The homology between the SARS-CoV-2 and SARS-CoV-1 spike proteins is high at 76 % across 100% of both sequences, therefore cross-reactivity is likely.

High Dose Hook Effect
No high dose hook effect was observed when UV inactivated SARS-CoV-2 virus at the concentration of 4.57×10 5 TCID50 /mL was tested with the C-Sync TM COVID-19 Antigen Test.

EXTERNAL QUALITY CONTROLS
External Positive and Negative Quality Controls are required to demonstrate the integrity of the cassette and to ensure the reagents and the assay procedure are working properly. External Positive and Negative Quality Controls should be used once by each new operator, with each new shipment and each new lot, and as deemed additionally necessary by laboratory internal quality control procedures, and in accordance with local, state and federal regulations or accreditation requirements. If the expected results are not obtained, do not perform patient tests or report patient results. Contact Technical Support.

TECHNICAL SUPPORT
For more information, please visit www.biosynchronicity.com
If you have any questions, please contact customer support at:
Phone: +1 425-898-3431
Email: support@biosynchronicity.com

INDEX OF SYMBOLS
Manufacturer
CE mark
Contains sufficient for test
Store between 2t and 30’C (36’F and 8f F)
**IVD**In Vitro Diagnostic device
Consult Instructions for Use
For prescription use only
Do not reuse
Do not use if package is damaged
Use by date
Catalog Number

Bio SynchronIcity Corporation
12835 Bel Red Rd, Suite 327 Bellevue, WA, 98005,
USA Email: support@biosynchronidty.com
www.biosynchronicity.com
QNET B.V. Kantstraar 19, 5076 NP Haaren, The Netherlands Email: EAR@ce- mark.com

External Quality Controls
for C-Sync™ COVID-19 Antigen Test

For use under the Emergency Use Authorization (EUA) only For use with the C-Sync TM
COVID-19 Antigen Test only
For in vitro diagnostic use
For prescription use only

Instructions for Use

INTENDED USE
The C-Sync TM COVID-19 Antigen Test External Quality Controls are to be used exclusively with the C-Sync TM COVID-19 Antigen Test to monitor the entire assay and provide assurance the test is performing within specifications.
SUMMARY AND EXPLANATION OF THE TEST
The C-Sync TM COVID-19 Antigen Test Quality Controls are external quality controls formulated specifically to demonstrate the integrity of the cassette and to ensure the reagents are working properly. The Quality Controls consist of a Negative Control and a Positive Control. Both Controls come in the form of a lyophilized powder. It is the responsibility of each laboratory or healthcare setting using the C-Sync TM COVID-19 Antigen Test to establish an adequate quality assurance program to ensure the performance of the test kit under its specific locations and conditions of use. The Positive and Negative controls should be run once with every new lot, every new shipment, and every new user, and quality control requirements should be followed in conformance with local, state, and federal regulations or accreditation requirements and the user laboratory’s standard quality control procedures.

MATERIALS PROVIDED 6 Sets:

• 6 C-Sync™ COVID-19 Antigen Test Positive Control Bottles (lyophilized powder with non-infectious recombinant SARS-CoV-2 nucleoprotein)
• 6 C-Sync™ COVID-19 Antigen Test  Negative Control Bottles (lyophilized powder)

TEST PROCEDURE
A. TEST PREPARATION
Wear appropriate personal protective equipment and gloves when running the test.
NEGATIVE CONTROL PROCEDURE

MATERIALS REQUIRED BUT NOT PROVIDED ™
COVID-19 Antigen Test cassette

• C-Sync
• Distilled water
• 1ml Pipettes
• Timer
• Personal Protective Equipment

WARNINGS AND PRECAUTIONS

•  For in vitro diagnostic use.
• Exercise the normal precautions required for handling all laboratory reagents.
• Do not swallow or inhale.
• Avoid contact with your eyes. If contact occurs, flush with copious amounts of water immediately.
• Do not mix different lots.
• STORAGE AND STABILITY
• Store the Quality Controls between 2°C and 8°C (36°F and 46°F) in a dark place until use.
• Each Quality Control can be stored between 2°C and 8°C (36°F and 46°F) up to 5 days after preparation in a dark place.
• Do not use the Quality Controls beyond the expiration date.

TEST PROCEDURE
A. TEST PREPARATION
Wear appropriate personal protective equipment and gloves when running the test.
NEGATIVE CONTROL PROCEDURE

**** Open the Negative Control bottle by gently removing the rubber plug.

Take 1 ml of purified water with a pipette and add it to the bottle.

Insert the rubber plug tightly and gently rotate the bottle to dissolve all the contents and obtain a solution. Do not shake the bottle to avoid creating bubbles.

Place a C-Sync™ cassette on a flat surface. With a different pipette, add 4 drops of the Negative Control solution to the sample well of the.

Read the results at 10 minutes. The tests should not be interpreted past 15 minutes.
The Control line (C-line) must be visible and the Test line (T-line) must not be visible. If the C-line is not visible or the T-line is visible, the results are invalid. Do not conduct tests with patients or report results. Contact technical support.
POSITIVE CONTROL PROCEDURE

****Open the Positive  petrol bottle by gently removing the rubber plug.

Take 1 ml of purified water with a pipette and add it to the bottle.

Insert the rubber plug tightly and gently rotate the bottle to dissolve all the contents and obtain a solution. Do not shake the bottle to avoid creating bubbles.

Place a C-Sync'” cassette on a flat surface.
With a different pipette, add 4 drops of the Positive Control solution to the sample well of the

Read the results at 10 minutes. The tests should not be interpreted past 15 minutes.
The Control line (C-line) must be visible and the Test line (T-line) must not be visible. If the C-line is not visible or the T-line is not visible, the test is invalid. Do not conduct tests with patients or report results. Contact technical support.
EMERGENCY USE AUTHORIZATION
In the USA, this product has not been FDA cleared or approved; but has been authorized by FDA under an EUA for use by authorized laboratory reissues by laboratories certified under the CLIA, 42 U.S.C. §263a, that meet requirements to perform moderate, high or waived complexity tests. This product is authorized for use at the Point of Care (POC), i.e., in patientcare settings operating under a CLIA Certificate of Waiver, Certificate of Compliance, or Certificate of Accreditation. This product has been authorized only (to be used with the C-Sync TM COVID-19 Antigen Test)for the detection of proteins from SARS-CoV-2, not for any other viruses or pathogens. In the USA, the emergency use of this product is only authorized for the duration of the declaration that circumstances exist just filing the authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of the virus that causes COVID-19 under Section 564(b)(1) of the Federal Food, Drug and Cosmetic Act, 21 U.S.C.§ 360bbb-3(b)(1), unless the declaration is terminated or authorizations revoked sooner.

INDEX OF SYMBOLS

| Manufacturer
---|---
**IVD**| In Vitro Diagnostic device
| Date of manufacture
| Consult Instructions for Use
| Contains sufficient for test
| Do not use if package is damaged
| Use by date
| Catalog Number
| Lot Number
| Store between 2°C and 30°C
| Keep away from sunlight
| For prescription use only

TECHNICAL SUPPORT
Phone: +1 425-898-3431
E-mail: support@biosynchronicity.com
www.biosynchronicity.com

External Quality Controls
for C-Sync™ COVID-19 Antigen Test Ver: 1-3.03 – March 2023

Bio Synchronicity Corporation
12835 Bel Red Rd, Suite 327
Bellevue, WA, 98005, USA

References

• HHS Accessibility & Section 508 | HHS.gov
• BioSynchronicity Corporation – BioSynchronicity
• BioSynchronicity Corporation – BioSynchronicity
• Coronavirus Disease 2019 (COVID-19) | CDC
• 800-222-1222" class="nturl" > Poison Control | Call Poison Help Centers Now 1-800-222-1222

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