STANDARD Q Q-NCOV-08G Covid 19 Ag Test 2.0 User Guide

STANDARD Q
COVID-19 Ag Test 2.0
STANDARD™ Q COVID-19 Ag Test 2.0
PLEASE READ INSTRUCTIONS CAREFULLY BEFORE YOU PERFORM THE TEST

EXPLANATION AND SUMMARY

Intended use
The STANDARD Q COVID-19 Ag Test 2.0 is a lateral flow immunoassay intended for the qualitative detection of nucleocapsid protein antigen 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 six (6) days of symptom onset when tested at least twice over three days with at least 48 hours between tests, and 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 complexity, high complexity, or waived 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 STANDARD Q COVID-19 Ag Test 2.0 does not differentiate between SARS-CoV and SARS- CoV-2. Results are for the identification of SARS-CoV-2 nucleocapsid protein antigen, which is generally detectable in anterior 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. 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 may be confirmed with a molecular assay, if necessary, for patient management. 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  patient’s recent exposures, history, and the presence of clinical signs and symptoms consistent with COVID-19. The STANDARD Q COVID-19 Ag Test 2.0 is intended for use by medical professionals or operators who are proficient in performing tests in a point of care setting. The STANDARD Q COVID-19 Ag Test 2.0 is only for in vitro diagnostic use under the Food and Drug Administration’s Emergency Use Authorization. This product has not been FDA cleared or approved.

Introduction
Coronaviruses are enveloped positive-stranded RNA viruses belonging to the Order of Nidovirales. In late 2019 a new coronavirus was identified in a cluster of pneumonia cases. The novel coronavirus, now known as SARS-CoV-2, has been classified as a member of the Sarbecovirus subgenus under the Betacoronavirus genus, and the disease associated with SARS-CoV-2 infection has been named COVID-19 (COronaVIrus Disease 2019). Due to the rapid rise in the number of cases and the scale of worldwide  spread, the World Health Organization (WHO) described the SARS-CoV-2 situation as pandemic on March 11, 2020. The clinical presentation of SARS-CoV-2 can range from asymptomatic infection to severe disease and even death. Symptoms of patients with confirmed SARS-CoV-2 infection vary from fever and dry cough to shortness of breath or difficulty in breathing. In addition, diarrhea and a loss of taste or smell have been reported after a SARS-CoV-2 infection. Symptom onset may appear up to 14 days after  exposure to the virus.

Test principle
The STANDARD Q COVID-19 Ag Test 2.0 has 2 pre-coated lines: a “C” Control line and a “T” Test line on the surface of the nitrocellulose membrane. Both the control line and test line in the result window are not visible before applying any specimens. Mouse
monoclonal anti-SARS-CoV-2 antibody is coated on the test line region and mouse monoclonal anti-Chicken IgY antibody is coated on the control line region. Mouse monoclonal anti-SARS-CoV-2 antibody conjugated with color particles are used as detectors for the SARS-CoV-2 antigen device. During the test, the SARS-CoV-2 antigen in the specimen interacts with monoclonal anti- SARS-CoV-2 antibody conjugated with color particles making an antigen-antibody color particle complex. This complex migrates on the  membrane via capillary action to the test line, where it is captured by the mouse monoclonal anti- SARS-CoV-2 antibody. A colored test line becomes visible in the result window if SARS-CoV-2 antigens are present in the sample.

ACTIVE COMPONENTS

• mAb anti-SARS-CoV-2 antibody
• mAb anti-Chicken IgY
• mAb anti-SARS-CoV-2 antibody-gold conjugate
• Purified chicken IgY-gold conjugate
• Recombinant SARS-CoV-2 nucleocapsid protein
• BSA (Bovine Serum Albumin)

KIT CONTENTS

MATERIALS REQUIRED BUT NOT PROVIDED

1. Personal protective equipment per local recommendations or requirements (i.e. gown/lab coat, face mask, face shield/eye goggles and gloves)
2. Timer
3. Biohazard waste container
   ※ Additional external positive/negative quality controls (STANDARD COVID-19 Ag Control; REF No. C-NCOV-03G) can be purchased separately.

STORAGE AND STABILITY
Store the kit at 36-86 °F / 2-30 °C and protect from direct sunlight. The expiry date of the materials is indicated on the external packaging. Do not freeze the kit.
WARNINGS AND PRECAUTIONS

• Read all instructions carefully before performing the test. Failure to follow the instructions may result in inaccurate test results.

• 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 SARSCoV-2, 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 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.

• 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 you have had symptoms longer than 6 days you should consider testing at least three times over five days with at least 48 hours between tests.

• Wear a safety mask or other face-covering when collecting a specimen from a child or another individual.

• Bring the kit contents and specimens to operating temperature (15-30°C/59-86 °F) before testing.

• Do not smoke, drink or eat while testing.

• Do not use the control swabs for sample collection from patients.

• If there is evidence of microbial contamination in the reconstituted control in the extraction buffer, discard the control.

• Wear protective clothing, mask, and gloves when handling specimens and reagents.
  Wash hands thoroughly after the tests are done.

• Handle and dispose of all specimens, controls and materials used in testing as though they contain infectious agents.

• Dispose of all samples and materials used to perform the test as biohazard waste.
  Laboratory chemical and biohazard wastes must be handled and discarded in accordance with all local, state, and national regulations.

• Do not use if any of the test kit contents or packaging is damaged.

• Test components are single-use. Do not re-use.

• Do not use kit past its expiration date.

• Do not open the kit contents until ready for use.

• Do not touch the swab tip.

• Testing should commence immediately after opening the sealed pouches.

• Do not read test results before 20 minutes or after 30 minutes. Results read before 20 minutes or after 30 minutes may lead to a false positive, false negative, or invalid result.

• The control line may show up within a few minutes of starting the test. It may take up to 20 minutes for a test line to show up.

• Make sure there is sufficient light when testing and reading the test results.

• Do not use nasal sprays for at least 30 minutes before collecting a nasal sample.

• In the event of a spillage, ensure it is cleaned thoroughly using a suitable disinfectant.

• If you suspect the presence of blood on the swab, discard the swab, make sure you are not bleeding, and repeat the test with a fresh swab.

• Remove any piercings from the nose before starting the test.

• Do not use on anyone who is prone to nosebleeds or has had facial injuries or head injuries/surgery in the past six months.

• Keep testing kit and kit components away from children and pets before and after use. Avoid contact with your skin and eyes. Do not ingest any kit components. The reagent solution contains harmful chemicals (see table below). If the solution contacts  your skin and eyes, flush with large amounts of water. If irritation persists, seek medical advice: https://www.poisonhelp.org or 1-800-222-1222.

Chemical dadf/ CAS| Hazard Category (mixture)| Hazard Statement for Mixture| Labeling of Harm(s)
---|---|---|---
Sodium chloride / 7647-14-5
L-Arginine / 74-79-3| Category 2| Eye irritation| May cause eye irritation
Polidocanol / 900292-0
ProClin®  300| Category 3| Skin irritation| Causes mild skin irritation

• If the reagent solution contacts the skin or eye, flush with plenty of water. If irritation persists, seek medical advice. https://www.poison.org/contact-us or 1-800-222-1222.
• For more information on EUAs please visit: https://www.fda.gov/emergency-preparedness-and-response/mcm-legalregulatory-and-policy-framework/emergency-use-authorization
• For the most up to date information on COVID-19, please visit: www.cdc.gov/COVID19

PREPARATION AND SPECIMEN COLLECTION FOR COVID-19 Ag TEST

Preparation

1. Bring test kit to room temperature (59-86 °F / 15-30 °C).

2. Wash your hands with soap and water, or use hand sanitizer before performing the test. Make sure you rinse thoroughly and your hands are dry before starting.

3. Check test expiry date on the back of the foil pouches. Do not use if the expiry date has passed.
   Testing should commence immediately after opening of the test device pouch.

4. Open the foil pouch by tearing along the tear- line.
   Remove the test device and desiccant package from the foil pouch. Place the test device on a flat surface.

5. Ensure that the test device is intact and that there are no green beads in the desiccant package (white and yellow beads are expected).
   Do not open the desiccant package.

TEST PROCEDURE

1. Remove the swab from the packaging. Ensure that you only touch the handle of the swab and not the soft pad at the tip.
   

2. Holding the stick end of the swab, gently insert the foam end of the swab into the nostril approximately ¾ of an inch. Rotate the swab at least 5 times, brushing against the inside walls of the nostril, for a total of 15 seconds.
   Do not just spin the swab.
   Using the same swab, repeat in the second nostril.
   Swab both nostrils. Inaccurate test results may occur if the nasal swab specimen is not properly collected.
   With children, the maximum depth of insertion into the nostril may be less than ¾ of an inch, and you may need to have a second person to hold the child’s head while swabbing.

3. Carefully open the extraction buffer tube avoiding spillage. If any liquid spills, do not use the tube.

4. Insert the swab into the extraction buffer tube until the soft pad is in the liquid.
   Squeeze the tube at the bottom and stir the swab more than 10 times while squeezing the tube. Remove the swab while squeezing the sides of the tube to extract the liquid from the swab. Dispose of the swab and seal the tube securely with the nozzle cap.
   Ensure that the nozzle cap is securely fitted before proceeding to the next step. Failure to squeeze the tube can lead to incorrect results due to excess buffer in the swab.

5. Hold the tube upright above the sample well. Drop 4 drops onto the sample well.
   Do not apply the liquid in the rectangular result window

6. Set the timer and read the test result at 20 minutes. Do not read the result before 20 minutes or after 30 minutes.
   Do not move or lift the test device during this time.

INTERNAL QUALITY CONTROL

A control line is used in the test as a procedural control. A visible control line confirms that the lateral flow of the test is successful but is not the confirmation that the specimen and buffer have been applied properly.
CIRCUMSTANCES FOR RUNNING QUALITY CONTROL TESTS
It is important to perform quality control tests with positive and negative control materials to ensure your system is working properly. It is recommended that positive and negative controls be run:

• Each new operator prior to performing testing on patient specimens,
• When opening a new test kit lot,
• Whenever a new shipment of test kits is received,
• If the temperature of the test kit storage area falls outside of 2°-30°C (35°-86°F), and
• At periodic intervals as dictated by the user facility, country, state or local regulations and policies :
  – Control tests may be ran prior to performing each serial testing on patient specimens.
  – Serial testing of STNADARD Q COVID-19 Ag Test 2.0 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.

PREPARATION AND PERFORMING A QUALITY CONTROL TEST

Preparation

1. Bring the STANDARD™ COVID-19 Ag Test 2.0 and the STANDARD™ COVID-19 Ag Control swab to operating temperature (15-30°C / 59-86°F) at least 30 minutes prior to the test.
2. Carefully read the Instructions for Use for the STANDARD™ COVID-19 Ag Test 2.0.
3. Check the expiration date on the pouches of the control and of the test device.
   Do not use expired control or test devices.

Test Procedure

1. Insert the positive or negative control swab into an extraction buffer tube which is in the STANDARD Q COVID-19 Ag Test 2.0. Stir the swab at least ten times while squeezing the sides of the buffer tube.
   Warning: Failure to squeeze the tube can lead to incorrect results due to excess buffer in the swab.

2. Remove the swab while squeezing the sides of the tube to extract the liquid from the swab. Dispose of the used swab in accordance with your biohazard waste disposal protocol.

3. Press the nozzle cap tightly onto the tube.

4. Apply 4 drops of the prepared control mixture into the specimen well of the test device.

5. Read the results in accordance with theInstructions for Use accompanying theSTANDARD Q COVID-19 Ag Test 2.0.
   Warning: Read the results at 20 minutes.Do not read before 20 minutes or after 30 minutes. Even faint lines should beconsidered as a valid result.

INTERPRETATION OF TEST RESULTS

COVID-19 Ag Test Interpretation
Inaccurate test interpretations may occur if results are read before 20 minutes or after 30 minutes.
Look at the result window and locate the letters C and T on the top side of the window. A colored line should always appear at the C position; this is the control line and signals that the test is working properly.

If the Control (C) line is visible, but the Test (T) line is not visible, the test is negative.
To increase the chance that the negative result for COVID-19 is accurate, you should:
• Test again in 48 hours if the individual has symptoms on the first day of testing.
• Test 2 more times at least 48 hours apart if the individual does not have symptoms on the first day of testing.

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 laboratorybased tests such as PCR tests. If the test is negative but COVID-19-like 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 SARSCoV-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.

Positive| | Positive result
If the Control (C) line and the Test (T) line are visible, the test is positive. Any faint visible,  colored test (T) line with the control line (C) should be read as 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 inthe 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 thelocal health authority immediately and instruct your patient to adhere to the localguidelines regarding self-isolation.
There is a very small chance that this test cangive a positive result that is incorrect (a false positive). Positive results do not ruleout 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 STANDARD Q COVID-19 Ag Test 2.0 should self-isolate and seek follow up care with their physician or healthcare provider as additional confirmatory testing with a molecular test forpositive 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 communitieswith low prevalence of infection.

Invalid| | Invalid result
If the control (C) line is not visible, the test is invalid. Re-test with a new swab and new test device.
If your test result is still invalid, please contact SD BIOSENSOR COVID-19 Support :
ts@sdbiosensor.com, +82-80-970-9700
---|---|---

Repeat testing is needed to improve test accuracy. Please follow the table below when interpreting test results.

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 forCOVID-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.

Quality Control Test Interpretation

STANDARD COVID-19 Ag Positive Control

Result| Interpretation| Follow up
Test Line (I)| Control Line (C)
Positive| Positive| Pass| –
Negative| Positive| Invalid| Retest
No control line (C)| Invalid| Retest

• Use new test devices and new control for retesting. If the invalid control test result recurs, contact SD BIOSENSOR Customer Service Center: ts@sdbiosensor.com

LIMITATION OF TEST

1. For in vitro diagnostic use.
2. For prescription use only.
3. The performance of this test was established based on the evaluation of a limited number of clinical specimens collected in December 2021 and February -March 2022. 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 SARS-CoV-2 and  their prevalence, which change over time.
4. 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.
5. All COVID-19 antigen test negative results are presumptive and confirmation with a molecular assay may be necessary.
6. 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.
7. 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.
8. This test is read visually and has not been validated for use by those with impaired vision or color-impaired vision.
9. Incorrect test results may occur if a specimen is incorrectly collected or handled.
10. 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.
11. This device is only used for testing direct human anterior nasal swab specimens. Viral transport media (VTM) should not be used with this test.
12. The amount of antigen in a sample may decrease as the duration of illness increases. Specimens collected after six days since symptoms onset are more likely to be negative compared to RT-PCR.
13. A negative test result may occur if the level of antigen in a sample is below the detection limit of the test or if the sample was collected improperly.
14. The performance of the STANDARD Q COVID-19 Ag Test 2.0 was evaluated using the procedures provided in these Instructions for Use (IFU) only. Modifications to these procedures may alter the performance of the test.
15. Failure to follow the Test Procedure may adversely affect test performance and/ or invalidate the test result.
16. Test results must be evaluated in conjunction with other clinical data available to the physician.
17. Positive test results do not rule out co-infections with other pathogens.
18. Negative test results are not intended to rule in other non-SARS viral or bacterial infections.

COVID-19 Ag Test 2.0
QUICK REFERENCE INSTRUCTIONS

KIT CONTENTS

Please study the Standard Q COVID-19 Ag Test 2.0 instructions for use thoroughly before using these Quick Reference Instructions or performing a test.
This is not a complete product insert.

Intended Use
The STANDARD Q COVID-19 Ag Test 2.0 is a lateral flow immunoassay intended for the qualitative detection of nucleocapsid protein antigen 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 six (6) days of symptom onset when tested at least twice over three days with at least 48 hours between tests, and 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.
The STANDARD COVID-19 Ag (Positive/Negative) Control swab is intended for use as an external quality control material to monitor the performance of STANDARD Q COVID-19 Ag Test 2.0.

PREPARATION

1. Bring test kit to room temperature (59-86 °F / 15-30 °C).

2. Wash your hands with soap and water, or use hand sanitizer before performing the test. Make sure you rinse thoroughly and your hands are dry before starting.

3. Check test expiry date on the back of the foil pouches. Do not use if the expiry date has passed.
   Testing should commence immediately after opening the test device pouch.

4. Open the foil pouch by tearing along the tear-line. Remove the test device and desiccant package from the foil pouch. Place the test device on a flat surface.

5. Ensure that the test device is intact and that there are no green beads in the desiccant package (white and yellow beads are expected). Do not open the desiccant package.

TEST PROCEDURE

1. Remove the swab from the packaging. Ensure that you only touch the handle of the swab and not the soft pad at the tip.
   

2. Gently insert the swab into the nostril approximately ¾ of an inch. Rotate the swab at least 5 times, brushing against the inside walls of the nostril, for about 15 seconds.
   Do not just spin the swab.
   Using the same swab, repeat in the second nostril.
   Swab Both Nostrils
   Inaccurate test results may occur if the nasal swab specimen is not properly collected.
   With children, the maximum depth of insertion into the nostril may be less than ¾ of an inch, and you may need to have a second person to hold the child’s head while swabbing.

3. Carefully open the extraction buffer tube avoiding spillage.
   If any liquid spills, do not use the tube.

4. Insert the swab into the extraction buffer tube until the soft pad is in the liquid. Squeeze the tube at the bottom and stir the swab more than 10 times while squeezing the tube. Remove the swab while squeezing the sides of the tube to extract the liquid from  the swab. Dispose of the swab and seal the tube securely with the nozzle cap.
   Ensure that the nozzle cap is securely fitted before proceeding to the next step Failure to squeeze the tube can lead to incorrect results due to excess buffer in the swab.

5. Hold the tube upright above the sample well. Drop 4 drops onto the sample well. Do not apply the liquid in the rectangular result window.

6. Set the timer and read the test result at 20 minutes. Do not read the result before 20 minutes or after 30 minutes. Do not move or lift the test device during this time.

CONTROL PREPARATION AND TEST PROCEDURE

Positive/Negative control
Preparation

1. Put the positive or negative control swab into an extraction buffer tube. While squeezing the buffer tube, stir the swab more than 5 times.
2. Remove the swab while squeezing the sides of the tube to extract the liquid from the swab.
3. Press the nozzle cap tightly onto the tube.

Test Procedure

1. Apply 4 drops of extraction buffer to the sample well. Do not apply the liquid in the rectangular result window.
2. Read the test result in 20-30 minutes.
   Do not move or lift the test device during this time.

INTERPRETATION OF TEST RESULTS

Negative result
If the Control (C) line is visible, but the Test (T) line is not visible, the test is negative.
To increase the chance that the negative result for COVID-19 is accurate, you should:

• Test again in 48 hours if the individual has symptoms on the first day of testing.
• Test 2 more times at least 48 hours apart if the individual does not have symptoms on the first day of testing.

Positive result
If the Control (C) line and the Test (T) line are visible, the test is positive. Any faint visible, colored test (T) line with the control line (C) should be read as positive.
Repeat testing does not need to be performed if patients have a positive result at any time.

Invaild result
If the control (C) line is not visible, the test is invalid. Re-test with a new swab and new test device.
If your test result is still invalid, please contact below.
Distribution in USA by SD BIOSENSOR USA, INC.
www.sdbiosensor.com
COVID-19 Support +82-80-970-9700
Manufactured by SD Biosensor, Inc.
Head office : C-4th&5th, 16, Deogyeong-daero 1556beon-gil, Yeongtong-gu,
Suwon-si, Gyeonggi-do, 16690, REPUBLIC OF KOREA
Manufacturing site : 74, Osongsaengmyeong 4-ro, Osong-eup, Heungdeok-gu,
Cheongju-si, Chungcheongbuk-do, 28161, REPUBLIC OF KOREA
Please contact us for any complaints/inquiries/suggestions via email (ts@sdbiosensor.com),
phone (+82-80-970-9700) or website (www.sdbiosensor.com).

STANDARD
COVID-19 Ag Control swab
STANDARD™ COVID-19 Ag Control swab
For in vitro diagnostic use only.
For prescription use only.
For use under the Emergency Use Authorization (EUA) only.
PLEASE READ INSTRUCTIONS CAREFULLY BEFORE YOU PERFORM THE TEST

INTENDED USE
STANDARD COVID-19 Ag Control swab is intended for use as an external quality control material to monitor the performance of STANDARD Q COVID-19 Ag Test 2.0.
For use only with STANDARD Q COVID-19 Ag Test 2.0.
KIT CONTENTS AND ACTIVE INGREDIENTS

• STANDARD COVID-19 Ag Positive Control swab: 5 swabs packed in individual pouches (red colored label). Positive control swabs contain recombinant SARSCoV-2 nucleocapsid protein, BSA (Bovine Serum Albumin) and excipients.
  The recombinant nucleocapsid protein works as an artificial antigen and it is used to verify if the system is working properly.

• STANDARD COVID-19 Ag Negative Control swab: 5 swabs packed in individual pouches (blue colored label). Negative control swabs do not contain active ingredients.

• Instructions for Use

MATERIALS REQUIRED BUT NOT PROVIDED

• STANDARD Q COVID-19 Ag Test 2.0 (REF No. Q-NCOV-08G)
• Timer
• Disposable gloves
• Biohazard waste container

STORAGE AND STABILITY
Store the STANDARD COVID-19 Ag Control swab at 2-30°C/36-86°F. Kit materials are stable until expiration date printed on the outer box.
WARNING AND PRECAUTIONS

1. Bring the kit contents and specimens to operating temperature (15-30 °C/ 59-86 °F) before testing.
2. Do not reuse the control swabs.
3. Do not use the control swabs if the pouch is damaged or the seal is broken.
4. Do not smoke, drink or eat while testing.
5. Do not use the control swabs for sample collection from patients.
6. If there is evidence of microbial contamination in the reconstituted control in the extraction buffer, discard the control.
7. Wear protective clothing, mask, and gloves when handling specimens and reagents. Wash hands thoroughly after the tests are done.
8. Clean any spillage by immediately and thoroughly wiping up with a suitable disinfectant such as 1% sodium hypochlorite solution.
9. Handle and dispose of all specimens, controls and materials used in testing as though they contain infectious agents.
10. Dispose of all samples and materials used to perform the test as biohazard waste. Laboratory chemical and biohazard wastes must be handled and discarded in accordance with all local, state, and national regulations.
11. Do not use kit materials if expiration date has passed.
12. In the event of damage of packaging, contact the distributor of this product at SD BIOSENSOR Customer Service Center ts@sdbiosensor.com

PREPARING A QUALITY CONTROL TEST

1. Bring the STANDARD™ COVID-19 Ag Test 2.0 and the STANDARD™ COVID-19 Ag Control swab to operating temperature (15-30°C / 59-86°F) at least 30 minutes prior to the test.
2. Carefully read the Instructions for Use for the STANDARD™ COVID-19 Ag Test 2.0.
3. Check the expiration date on the pouches of the control and of the test device.
   Do not use expired control or test devices.

PERFORMING A QUALITY CONTROL TEST

1. Insert the positive or negative control swab into an extraction buffer tube which is in the STANDARD Q COVID-19
   Ag Test 2.0. Stir the swab at least ten times while squeezing the sides of the buffer tube.
   Warning: Failure to squeeze the tube can lead to incorrect results due to excess buffer in the swab.

2. Remove the swab while squeezing the sides of the tube to extract the liquid from the swab. Dispose of the used swab in accordance with your biohazard waste disposal protocol.

3. Press the nozzle cap tightly onto the tube.

4. Apply 4 drops of the prepared control mixture into the specimen well of the test device.

5. Read the results in accordance with the Instructions for Use accompanying the STANDARD Q COVID-19 Ag Test 2.0.
   Warning: Read the results at 20 minutes.
   Do not read before 20 minutes or after 30 minutes. Even faint lines should be considered as a valid result.

LIMITATIONS

1. For in vitro diagnostic use.
2. For prescription use only.
3. This product has not been FDA cleared or approved; but has been authorized by FDA under an Emergency Use Authorization (EUA).
4. 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 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.
5. Do not use kit contents beyond the expiration date printed on the outside of the box.
6. The test procedure, precautions and interpretation of results for this test must be followed strictly when testing.
7. Failure to follow the test procedure and interpretation of test results may adversely affect test performance and/or produce invalid results.
8. This product is provided for quality assurance purposes and must not be used for calibration or as primary reference preparations in any test procedure.
9. Adverse storage conditions or use of outdated reagents may produce erroneous results.
10. Alterations in physical appearance may indicate instability or deterioration of this product. If there is evidence of microbial contamination in this product, discard it.
    FOR US CUSTOMERS ONLY-LIMITED WARRANTY:
    SD BIOSENSOR warrants that this product will be free from defects in material and workmanship until the expiration date printed on the label. THIS LIMITED WARRANTY IS IN LIEU OF ANY OTHER WARRANTY, EXPRESS OR IMPLIED, INCLUDING ANY IMPLIED WARRANTY OF MERCHANTABILITY OR FITNESS FOR PARTICULAR PURPOSE. IN NO EVENT SHALL SD BIOSENSOR BE LIABLE FOR INCIDENTAL, INDIRECT, SPECIAL OR CONSEQUENTIAL DAMAGES.

Distribution in USA by
SD BIOSENSOR USA, INC.
www.sdbiosensor.com
COVID-19 Support +82-80-970-9700
Manufactured by SD Biosensor, Inc.
Head office : C-4th&5th, 16, Deogyeong-daero 1556beon-gil, Yeongtonggu, Suwon- si, Gyeonggi-do, 16690, REPUBLIC OF
KOREA
Manufacturing site :
74, Osongsaengmyeong
4-ro,
Osong-eup,
Heungdeok-gu, Cheongju-si, Chungcheongbuk-do, 28161, REPUBLIC OF KOREA
Please contact us for any complaints/inquiries/suggestions via email (ts@sdbiosensor.com),
phone (+82-80-970-9700) or website (www.sdbiosensor.com).
L24COVC14JNCENR1
Issue date: 2023.09

References

• cat.no
• HHS Accessibility & Section 508 | HHS.gov
• Centers for Disease Control and Prevention
• SD BIOSENSOR
• Centers for Disease Control and Prevention
• Contact Us | Poison Control
• Coronavirus disease (COVID-19)

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