Aurora Biomed FaStep COVID-19 Rapid Antigen Test Instructions

Aurora Biomed FaStep COVID-19 Rapid Antigen Test Instructions

STORAGE AND STABILITY

• Store The COVID-19 Antigen Rapid Test Device at 2-30 t when not in use.
• DO NOT FREEZE.
• Kit contents are stable until the expiration dates marked on their outer packaging and containers.

SPECIMEN COLLECTION AND STORAGE

Nasopharyngeal swab (NP swab):

1. Remove the swab from its packing
2. Insert the swab into the nostril parallel to the palate. Rotating against the nasal wall. (to ensure swab  contains cells as well as mucus)
3. Process the swab as soon as possible after collecting the specimen

Nasal swab (NS swab)

1.  Remove the swab from its packing.
2. Put the swab gently into nostril (about I -2cm up your nose). Roll the swab firmly around the inside of the nostril, making 5 complete circles. Repeat this process for the other nostril to ensure that an adequate. Specimen is collected from both nasal cavities. (use the same swab)
3. Process the swab as soon as possible after collecting the specimen.

Note:

1. Use only synthetic fiber swabs with plastic shafts. Do not use calcium alginate swabs or swabs with wooden shafts, as they may contain substances that inactivate some viruses and inhibit further testing.
2. Swabs specimens should be tested as soon as possible after collection. Use freshly collected specimens for best test performance.
3. If not tested immediately, swab specimens may be stored at 2-8°C for 24 hours after collection.
4. Do not use specimens that are obviously contaminate with blood, as it may interfere with the flow of sample with the interpretation of test results.

TEST PROCEDURE

Bring devices, reagents and specimens and/or controls to room temperature (15-30t) before use.

1. For each specimen, open the foil pouch just before testing and remove the test device, and put it on a clean, level surface. Label the tube with the patient identification. For best results, the assay should be performed within one hour.
2. Take off the blue cap of the extraction tube and insert the swab into the extraction tube. Mix well and squeeze the swab 10-15 times by compressing the walls of the tube against the swab. Stand for 2 minutes.
3. Roll the swab head against the inner wall of the tube as you remove it. Try to release as much liquid as possible. Dispose of the used swab in accordance with your biohazard waste disposal protocol.
4. Place the blue cap back to the extraction tube. Unscrew the white cap and add 3 drops of solution into the sample well by gently squeezing the tube.
5. Read results at 15 minutes. Do not interpret the result after 30 minutes
   
   

RESULT INTERPRETATION

POSITIVE: Two colored bands appear on the membrane. One band appears in the  control region (C) and another band appears in the test region (T).

NEGATIVE: Only one colored band appears, in the control region (C). No apparent colored band appears in the test region (1).

INVALID: Control band fails to appear. Results from any test which has not produced a control band at the specified read time must be discarded. Please review the procedure and repeat with a new test. If the problem persists, discontinue using the kit immediately and contact your local distributor.

NOTE:

1. The color intensity in the test region (T) may vary depending on the concentration of analytes present in the specimen. Therefore, any shade of color in the test region should be considered positive.
   Note that this is a qualitative test only, and cannot determine the concentration of analytes in the specimen.

2. Insufficient specimen volume, incorrect operating procedure or expired tests are the most likely reasons for control band failure.

QUALITY CONTROL

Internal Procedural Controls The COVID-19 Antigen Rapid Test Device has built-in (procedural) controls. Each test device has an internal standard zone to ensure proper sample flow. The user should confirm that the colored band located at the “C” region is present before reading the result. External Positive and Negative Controls Positive and negative control should be tested to ensure the proper performance of the assay. It is a recommended to test those positive and negative controls when a new lot of tests is open. When performed properly, in addition to the presence of C line, no line should be visible for the negative control and the T line is visible for the positive controls. Additional controls may be qualified and tested by the user

LIMITATION OF THE TEST

1. The COVID-19 Antigen Rapid Test Device is for professional in vitro diagnostic use, and should only be used for the qualitative detection of SARS-CoV-2 antigen. The intensity of color in a positive band should not be evaluated as “quantitative or semi-quantitative”
2. Both viable and nonviable SARS-CoV-2 viruses are detectable with The COVID-19 Antigen Rapid Test Device.
3. As with all diagnostic tests, a definitive clinical diagnosis should not be based on the results of a single test, but should only be made by the physician after all clinical and laboratory findings have been evaluated. i)

Analytical Sensitivi imit of Detection):

The limit of detection was 2×10?*TCIDso/mL, and was determined using inactivated SARS-CoV-2 virus spiked onto swabs.

Cross Reactivity and Microbial Interference:

There was no cross-reaction with the following organisms tested with the COVID-19 Antigen Rapid Test Device.

agalactiae
Bordetella pertussis| Haemophilus influenzae| Candida albicans
In fluenzaA (HINI)pdm09| Human inetapneumovirus| Group C Streptococcus
Influenza A (H3N2)| Rhinovirus| Staphylococcus aureus
Mycobacterium tuberculosis| Pooled human nasal wash — representative of normal respiratory microbial flora

Interfering Substances

The following substances, naturally present in respiratory specimens or that may be artificially introduced into the respiratory tract, were evaluated at the concentrations listed below. None of them were found to affect test performance of The COVID-19 Antigen Rapid Test Device.

High-dose Hook Effect

The COVID-19 Antigen Rapid Test Device demonstrated that no hook effect at 1×10°* TCIDso/mL.

LITERATURE REFERENCES

1.  Forni, D., Cagliani, R., Clerici, M. & Sironi, M. Molecular evolution of human coronavirus genomes. Trends Microbiol. 25, 35-48 (2017).
2. Ithete, N. L. et al. Close relative of human Middle East respiratory syndrome coronavirus in bat, South Africa. Emerg. Infect. Dis. 19, 1697-1699 (2013).

GLOSSARY OF SYMBOLS

| Catalog number| | Temperature limitation
---|---|---|---
|  Consult instructions for use| | Batch code

| In vitro diagnostic medical device| | Use by
| Manufacturer| | Do not reuse

Assure Tech. (Hangzhou) Co., Ltd.

Building 4, No. 1418-50, Moganshan Road, Gongshu District, Hangzhou, Zhejiang 310011, P.R. China

Customer Service
Phone:+ 86 571 8102 2698
Service date/hours: Monday through Friday 8:30 AM to 5:30 PM.

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