ALL TEST ICOV-802H COVID-19 Antigen Rapid Test Oral Fluid Instruction Manual

ALL TEST ICOV-802H COVID-19 Antigen Rapid Test Oral Fluid

Product Information: COVID-19 Antigen Rapid Test (Oral Fluid)

Package Insert: REF ICOV-802H

• Intended Use: The COVID-19 Antigen Rapid Test (Oral Fluid) is a qualitative membrane-based immunoassay for the detection of SARSCoV-2 Antigens in human oral fluid specimens.
• Principle: The test device contains anti-SARS-CoV-2 antibodies that react with SARSCoV-2 Antigens present in the oral fluid specimen.
• Reagents: The test device contains anti-SARS-CoV-2 antibodies.
• Storage: Store the test device and buffer in a dry place at 2-30°C (36-86°F). Do not freeze. The buffer should be stored in its original bottle and tightly closed.

Limitations:

• Failure to follow the testing steps may give inaccurate results.
• The COVID-19 Antigen Rapid Test (Oral Fluid) is for self-testing in vitro diagnostic use only.
• The results obtained with the test should be considered with other clinical findings from other laboratory tests and evaluations.
• If the test result is negative or non-reactive and clinical symptoms persist, it is because the very early infection virus.

Performance Characteristics:
The COVID-19 Antigen Rapid Test (Oral Fluid) has been evaluated with specimens obtained from patients. RT-PCR is used as the reference method for the COVID-19 Antigen Rapid Test (Oral Fluid). The sensitivity, specificity, and accuracy of the test are as follows:

• Relative Sensitivity: 90.1% (95%CI*: 82.5%~95.1%)
• Relative Specificity: 99.3% (95%CI*: 97.7%~99.9%)
• Accuracy: 97.0% (95%CI*: 94.9%~98.5%)

Cross-reactivity:

Our test results indicated that there is cross-reactivity between SARS-CoV-1 and SARS-CoV-2 at a concentration equal to or more than 1ng/ml in the detection of SARS-CoV-1 recombinant nucleocapsid protein. This is because SARS-CoV has high homology to SARS-CoV-2.

Product Usage Instructions: COVID-19 Antigen Rapid Test (Oral Fluid)

1. Before testing, scan the QR code to watch the “how to use” video or visit www.mycovidtest.com.au/how-it-works/.
2. Wash hands thoroughly before and after handling the test kit.
3. Open the test kit package and take out all the provided items: test device, buffer, package insert, biosafety bag, and collection device (funnel, tube, and tube tip).
4. Read the entire package insert carefully before performing the test.
5. Do not eat, drink, or smoke in the area where the specimens or kits are handled.
6. Do not drink the buffer in the kit. Carefully handle the bufferand avoid it contacting the skin or eyes. Rinse with plenty of running water immediately if contact occurs.
7. Do not use the test if the pouch is damaged.
8. If self-testing for children and young people, it should be done with an adult present.
9. Collect an oral fluid specimen using the provided collectiondevice (funnel, tube, and tube tip) following the instructions provided in the package insert.
10. Add the collected oral fluid specimen to the sample well of the test device.
11. Add the buffer to the buffer well of the test device following the instructions provided in the package insert.
12. Set a timer according to the test’s specified incubationtime.
13. After the incubation time, read the test results as instructed in the package insert.
14. If the result is preliminary positive, share your test result with your healthcare provider and carefully follow your local COVID guidelines/requirements.
15. Discard the used test according to local regulations.

Note: A timer is not provided with the test kit. Please use your own timer to track the incubation time accurately.

INTENDED USE

The COVID-19 Antigen Rapid Test (Oral Fluid) is a single-use test kit intended to detect the novel coronavirus SARS-CoV-2 that causes COVID-19 in human oral fluid. This test is designed for home use1 with self-collected oral fluid samples from symptomatic individuals who are suspected of being infected with COVID-19 within the first 7 days of symptom onset.
The COVID-19 Antigen Rapid Test (Oral Fluid) obtain a preliminary result only, the final confirmation should be based on clinical diagnostic results.
The COVID-19 Antigen Rapid Test (Oral Fluid) is intended to be used by laypersons as a self-test for home and workplace (in offices, for sporting events, airports, schools, etc.).

SUMMARY
The novel coronaviruses belong to the β genus. COVID-19 is an acute respiratory infectious disease. People are generally susceptible. Currently, the patients infected by the novel coronavirus are the main source of infection; asymptomatic infected people can also be an infectious source. Based on the current epidemiological investigation, the incubation period is 1 to 14 days, mostly 3 to 7 days. The main manifestations include fever, fatigue and dry cough. Nasal congestion, runny nose, sore throat, myalgia and diarrhea are found in a few cases.

PRINCIPLE
The COVID-19 Antigen Rapid Test (Oral Fluid) is a qualitative membrane-based immunoassay for the detection of SARS-CoV-2 Antigens in human oral fluid specimen.

REAGENTS
The test device contains anti-SARS-CoV-2 antibodies.

WARNING

1. Read the entire package insert prior to performing test.
2. The test is for one time use only, do not reuse the test. Do not use after expiration date.
3. Do not eat, drink or smoke in the area where the specimens or kits are handled.
4. Do not drink the buffer in the kit. Carefully handle the buffer and avoid it contacting skin or eyes, rinse with plenty of running water immediately if contacting.
5. Do not use test if pouch is damaged.
6. Wash hands thoroughly before and after handling.
7. If the result is preliminary positive, share your test result with your healthcare provider and carefully follow your local COVID guidelines/requirements.
8. Test for children and young people should be used with an adult.
9. The used test should be discarded according to local regulations.

STORAGE
Store the test at 35.6-86°F (2-30°C). Do not open the pouch until ready for use. DO NOT FREEZE.

ITEMS PROVIDED

• Test device
• Buffer
• Package insert
• Biosafety Bag
• Collection device (Funnel, tube and tube tip)

ITEMS NOT PROVIDED

• Timer

LIMITATIONS

1. Failure to follow the testing steps may give inaccurate results.
2. The COVID-19 Antigen Rapid Test (Oral Fluid) is for self-testing in vitro diagnostic use only.
3. The results obtained with the test should be considered with other clinical findings from other laboratory tests and evaluations.
4. If the test result is negative or non-reactive and clinical symptoms persist, it is because the very early infection virus may not be detected, It is recommended to test again with a new test 1-2 days later or go to the hospital to rule out infection.
5. Positive results of COVID-19 may be due to infection with non-SARS-CoV-2 coronavirus strains or other interference factors.
6. The COVID-19 Antigen Rapid Test (Oral Fluid) is less reliable in the later phase of infection, it is recommend to use the test within the first 7 days of symptom onset.
7. Negative results may not mean that a person is not infectious and if symptoms are present you must seek immediate further testing Via the PCR Method.
8. A negative result does not rule out infection with another type of respiratory virus
9. The test is for one time use only, do not reuse the test.
10. Test for children and young people should be supervised with an adult.
11. Please keep out of reach of children
12. If a Positive result is given the immediate requirement is to present to your nearest Covid Testing Clinic for a confirmatory PCR Test. For advice on how to seek medical help or get tested for coronavirus (COVID-19) Please refer to last page of this Instruction for use to see your state or territory contact details .
13. Contact the TGA to report poor performance or usability issues in the self-test environment (report an issue via the Users Medical Device Incident Report, email: iris@tga.gov.au or call 1800 809 36

PERFORMANCE CHARACTERISTICS
Sensitivity, Specificity and Accuracy
The COVID-19 Antigen Rapid Test (Oral Fluid) has been evaluated with specimens obtained from the patients. RT-PCR is used as the reference method for the COVID-19 Antigen Rapid Test (Oral Fluid). Specimens were considered positive if the individuals were indicated positive results by RT-PCR. Specimens were considered negative if the individuals were indicated negative results by RT- PCR

Oral Fluid Specimen

COVID-19 Antigen Rapid Test (Oral Fluid)| RT- PCR| ****

Total

---|---|---
Positive| Negative
COVID-19 Antigen| Positive| 91| 2| 93
Negative| 10| 303| 313
Total| 101| 305| 406
Relative Sensitivity| 90.1% (95%CI:82.5%~95.1%)
---|---
Relative Specificity| 99.3% (95%CI: 97.7%~ 99.9%)
Accuracy| 97.0% (95%CI*:94.9%~98.5%)
Days since symptom| RT- PCR| COVID-19 Antigen Rapid Test| Agreement (%)
---|---|---|---
0 – 3| 39| 33| 84.6%
4 – 7| 62| 58| 93.5%
CT Value| RT-PCR Positive| COVID-19 Antigen Rapid Tet Positive| Agreement (%)
---|---|---|---
Ct≤20| 8| 8| 100%
20<Ct≤25| 43| 42| 97.7%
25<Ct≤30| 46| 40| 87.0%
Ct>30| 4| 1| 25%

Limitation of Detection
The COVID-19 Antigen Rapid Test can detect out SARS-CoV-2 heat-inactivated virus strain as low as 8X102  TCID50/ml.

Variant
The SARS-CoV-2 variant Alpha(UK B.1.1.7), Delta(Indian B.1.617.2), Gamma( B.1.1.28), VUI-21ARP-03(Indian
B.1.617.3) and Beta (South Africa B.1.351) could be detected out by the SARS- CoV-2 Antigen Rapid Test at specific concentrations
WHO LABEL , Pango Lineages ,(Conc), ALPHA , B.1.1.7, (102viral RNA copies/μL), BETA , B.1.351, (10 viral RNA copies/μL), VUI-21ARP-03, B.1.6173, (0.21ng/ml), GAMMA, B.1.1.28, (102 viral RNA copies/μL), DELTA, B.1.617.2, (105 viral RNA copies/μL)

Hook Effect
The highest concentration of SARS-CoV-2 inactivated virus was tested. There was no Hook effect detected Specificity Testing with Various Viral Strains
The COVID-19 Antigen Rapid Test was tested with the following viral strains. No discernible line at either of the test-line regions was observed at these concentrations.
Description, (Conc), Adenovirus type 3, (3.16 x 104 TCID50/ml), Influenza B, (3.16 x 106 TCID50/ml)
Adenovirus type 7,( 1.58 x 105 TCID50/ml), Measles, (1.58 x 104 TCID50/ml), Human coronavirus OC43, (1 x 106 TCID50/ml), Mumps, (1.58 x 104 TCID50/ml), Human coronavirus 229E, (5 x 105 TCID50/ml), Parainfluenza virus 2, (1.58 x 107 TCID50/ml), Human coronavirus NL63, (1 x 106 TCID50/ml), Parainfluenza virus 3, (1.58 x 108 TCID50/ml), Human coronavirus HKU1, (1 x 106 TCID50/ml), Respiratory syncytial virus, (8.89 x 104 TCID50/ml)
MERS-coronavirus Florida, (1.17 x 104TCID50/ml), Enterovirus Type 68 (2007 Isolate), (1.51 x 106 TCID50/ml) Influenza A H1N1, (3.16 x 105 TCID50/ml), Haemophilus influenzae type b, (1.35 x 109 CFU/ml), Influenza A H3N2, (1 x 105 TCID50/ml)
TCID50 = Tissue Culture Infectious Dose is the dilution of virus that under the conditions of the assay can be expected to infect 50% of the culture vessels inoculated.

Precision
Intra-Assay &Inter-Assay
Within-run and Between-run precision ha been determined by using three specimens of COVID-19 standard control. Three different lots of COViD-19 Antigen Rapid Test (Oral Fluid) have been tested using negative SARS-CoV-2 Antigen weak and SARS-CoV-2 Antigen strong. Ten replicates of each level were tested each day for 3 consecutive days. The specimens were correctly identified >99% of the time.

Cross-reactivity
The following organism were tested, and all found to be negative when tested with COVID-19 Antigen Rapid Test (Oral Fluid):
Description, (Conc), Arcanobacterium, (1.0×108 CFU/ml), Staphylococcus epidermidis, (1.0×108 CFU/ml), Candida albicans, (1.0×108 CFU/ml), Streptococcus pneumonia, (1.0×108 CFU/ml), Corynebacterium, (1.0×108 CFU/ml), Streptococcus pygenes, (1.0×108 CFU/ml), Escherichia coli, (1.0×108 CFU/ml), Streptococcus salivarius, (1.0×108 CFU/ml), Moraxella catarrhalis, (1.0×108 CFU/ml), Streptococcus sp group F, (1.0×108 CFU/ml), Neisseria lactamica, (1.0×108 CFU/ml), Chlamydia pneumoniae, (1.73×108 CFU/ml), Neisseria subflava, (1.0×108 CFU/ml), Legionella pneumophila Philadelphia, (1.91×1010 IFU/ml), Pseudomonas aeruainosa, (1.0×108 CFU/ml), Bordetella pertussis A639, (6.43×109 CFU/ml), Staphylococcus aureus subspaureus, (1.0×108 CFU/ml), Mycoplasma pneumoniae M129, 2.70×108 CCU/ml
Our Test Results indicated there is the cross reactivity between SARS-CoV-1 and SARS-CoV-2 at the concentration equal to or more than 1ng/ml in detection of SARS-CoV-1 recombinant nucleocapsid protein. This is because SARS-CoV has high homology to the SARS-CoV-2.

Interfering Substances
The following substances were tested with COVID-19 Antigen Rapid Test (Oral Fluid) and no interference was observed.
Description, (Conc), Dexamethasone, (0.8mg/ml), Tea, (33.3mg/ml), Mucin, (50μ/ml), Milk, (11.2%), Flunisolide, (6.8ng/ml), Orange juice, (100%), Mupirocin, (12mg/ml), Mouthwash, (2%), Oxymetazoline, (0.6mg/ml), Caffeine, (1mg/ml), Phenylephrine, (12mg/ml), Coca Cola,( / ), Rebetol, (4.5μg/ml), Toothpaste,( / ), Relenza, (282ng/ml), Whole Blood, (20μg/ml) Tamiflu, (1.1μg/ml), HAMA, (1mg/ml), Tobryamycin, (2.43mg/ml), Biotin,(0.1mg/ml) Q&A

• How do I know if the Test worked well?
  COVID-19 Antigen Rapid Test is a rapid chromatographic immunoassay for the qualitative detection of SARS-CoV-2 antigens present in human oral fluid. When the control line(C) appears, it means the test unit is performing well.

• How soon can I read my results?
  You can read your results after 15 minutes as long as a colored line has appeared next to the Control region(C), do not read result after 20 minutes.

• When is the best time to run the test?
  Test can be done at any time of the day. However It is recommended to collect the first oral fluid in the morning.

• Can the result be wrong? Are there any factors that can affect the test result?
  The results will only give accurate results as far as the fresh human oral fluid is used and followed the instructions carefully. Nevertheless, the result can be incorrect.
  Non-SARS-CoV-2 coronavirus strains or other interference factors may cause a preliminary Positive Result.

• How to read the test if the color and the intensity of the lines are different?
  The color and intensity of the lines have no importance for result interpretation. The test should be considered as Positive whatever the color intensity of the test line (T) is.

• What do I have to do if the result is positive?
  A positive result means the presence of SARS-CoV-2 antigens. A positive results means it is very likely you have COVID-19 and the result should be confirmed. Immediately go into self-isolation in accordance with the local guidelines and immediately contact your general practitioner / doctor or the local health department in accordance with the instructions of your local authorities. Your test result will be checked by a PCR confirmation test and you will be explained the next steps.

• What do I have to do if the result is negative?
  A negative result means that you are negative or that the viral load is too low to be recognized by the test. However, it is possible for this test to give a negative result that is incorrect (a false negative) in some people with COVID-19. This means you could possibly still have COVID-19 even though the test is negative.
  If you experience symptoms such as headaches, migraines, fever, loss of sense of smell and taste, contact the nearest medical facility using the rules of your local authority. In addition, you can repeat the test with a new test kit. In case of suspicion, repeat the test after 1-2 days, as the coronavirus cannot be precisely detected in all phases of an infection. Distance and hygiene rules must still be observed. Even with a negative test result, distance and hygiene rules must be observed, migration/traveling, attending events and etc should follow your local COVID guidelines/requirements.

• Information of how to contact locally available support services.
  For advice on how to seek medical help or get tested for coronavirus (COVID-19) you can contact your state or territory health authority, or call the coronavirus (COVID-19) helpline on 1800 020 080 at any time or visit the website: https://www.australia.gov.au/phone-contacts.
  Contact the TGA to report poor performance or usability issues in the self- test environment (report an issue via the Users Medical Device Incident Report, email: iris@tga.gov.au or call 1800 809 361).

REFERENCES

• BACKINGER, C.L. and KINGSLEY, P.A., Recommendations for Developing User Instruction Manuals for Medical Devices Used in Home Health Care, Rockville, MD, U.S. Food and Drug Administration, Center for Devices and Radiological Health, HHS Pub. FDA 93-4258.

For Customer Support Call: 1800 472 743
For information on the correct use of this test and for interpretation of the test results.

Customer Service Hours: 24 Hours 7 Days

LOCAL CONTACT DETAILS
TO LOCATE YOUR NEAREST COVID TESTING CENTRE AND LABORATORY PLEASE CONTACT

STATE AND TERRITORY CONTACT NUMBERS

• Confirmatory testing of positive results by a laboratory PCR test is required.
• Australian Capital Territory Coronavirus Helpline (8am-8pm daily ) 02 6207 7244
• New South Wales Coronavirus Helpline (Service NSW 24/7) 137 788
• Northern Territory Coronavirus National Hotline ( National Helpline) 1800 020 080
• Queensland Coronavirus Helpline ( 134COVID) 134 268
• South Australia Coronavirus Helpline ( 9am -5 pm Daily) 1800 253 787
• Tasmanian Public Health Hotline (Coronvirus) 1800 671 738
• Victoria Coronavirus Hotline (24/7) 1800 675 398
• Western Australia Coronavirus Hotline 13COVID (8am- 6pm , Mon-Fri) 1800 595 206
• Confirmatory testing of positive results by a laboratory PCR test is required.

INDEX OF SYMBOLS

Sponsored By:
AM Diagnostics Pty Ltd
Unit 8, 25 Wicks Street
Bayswater, WESTERN AUSTRALIA 6053
PH: 1800 472 743
www.mycovidtest.com.au
Number: 146561800

BEFORE STARTING

Before collecting oral fluid, nothing is to be placed in the mouth including food, drink, gum, or tobacco products for at least 10 minutes prior to collection.
Was or sanities your hands.
Make sure they are dry before starting.

MATERIALS PROVIDED

PREPARE FOR THE TEST

• Check the expiration date on the box. Do not use if  the kit has expired.
• Ensure the kit is at room temperature for at least 30 minutes prior to use.
  Open the box carefully as it will be used in a later step. Do not open individual components until instructed.
  Note: A time device (clock, timer, etc) is required, but not provided.

COLLECT SAMPLE

Deeply cough 3 – 5 times
Note: Wear a face mask or cover your mouth and nose with a tissue when you are coughing and keep distance with other people.

For Customer Support Call 1800 472 743 for information on the correct use of this test and for interpretation of the test results. Customer service hours are: 24 Hours , 7 Days

ADD BUFFER

ADD DROPS

WAIT FOR RESULTS

Do not touch the Test Device during this period.

Read the result at 15 minutes.
Do not read the result earlier than 15 minutes or after 20 minutes.

Note: A control (C) line may appear in the result window within a few minutes, but a test (T) line may take as long as 15 minutes to appear.
Note: After 20 minutes the result might become inaccurate.

READ TEST RESULT

Please share your test result with your healthcare provider and carefully follow your local COVID guidelines/requirements

INVALID RESULT (Test did not work)
Insufficient specimen volume or incorrect procedural techniques are the most likely reasons for control line failure. Review the procedure and repeat the test with a new test or contact our COVID-19 test centre.

POSITIVE RESULT
One coloured line should be in the control region (C) and another coloured line should be in the Test region (T).

*Note: The intensity of the colour in the test line region (T) will vary based on the amount of SARS-(CoV-2 antigen present in the sample. So any shade of colour in the test region (T) should be considered positive. A positive result means it is very likely you have COVID-19, but the positive samples should be confirmed to reflect this. Immediately go into self-isolation in accordance with the local guidelines and immediately contact your general practitioner/doctor or the local health department in accordance with the instructions of your local authorities.
Your test result will be check by a PCR confirmation test and you will be explained the next steps.

For ALL Positive results a Confirmatory PCR test by a laboratory is required. Please contact your local COVID Help Line on the reverse side of these instructions.

NEGATIVE RESULT
No apparent coloured line appears in the test line region (T)
You are unlikely to have COVID-19. However, it is possible for this test to give a negative result that is incorrect (a false negative) in some people with COVID-19. This means you could possibly still have COVID-19 even though the test is negative.
If you experience symptoms such as headaches, migraines, fever, loss of sense of smell or taste, contact the nearest medical facility according to the rules of our local authority. In addition, you can repeat the test with a new test kit. In case of suspicion repeat the test after 1-2 days, as the corona virus cannot be precisely detected in all phases of an infection.
Even with a negative test result, distance yourself and hygiene rules must be observed, migration/traveling, attending events, etc, you should follow your local COVID
guidelines/requirements.

DISPOSE THE TEST KIT

• After the test is complete, place all the components into the plastic Bio-Safety bag (supplied)
• Dispose according to local regulations

References

• My Covid Test - At Home Covid Test Kits
• How to Use Our Products – My Covid Test
• COVID-19 Emergency Contacts

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