Covid-19 Test Kit for Self-Testing (Australia)
INTENDED USE
COVID-19 Test Kit (Colloidal Gold Method) is a solid phase immunochromatographic assay for the rapid, qualitative detection of antigen to 2019 Novel Coronavirus in human nasal cavity. This test is used to detect nucleocapsid antigen of the SARS-CoV-2 virus in individuals suspected of having COVID-19.
It is designed as a self-test for patients. This test provides only a preliminary result. For best performance, it is recommended this test be used within 7 days post-onset of symptoms.
Any COVID-19 variants (including Alpha (B.1.1.7), Beta (B.1.351), Gamma (P.1), Delta (B.1.617.2), Omicron (B.1.1.529)) are detected by this test without any impact on performance.
PACK FORMATS
1 test/box, 5 tests/box, 20 tests/box
INTRODUCTION
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; asymptomatically 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 Test Kit (Colloidal Gold Method) is a colloidal gold immunochromatographic assay. It detects the nucleocapsid protein on the surface of COVID-19.
The test uses COVID-19 (SARS-CoV-2) antibody (test line T) and goat anti-mouse IgG (control line C) immobile- ised on a nitrocellulose strip. The burgundy colored conjugate pad contains colloidal gold conjugated to another COVID-19 (SARS-CoV-2) antibody conjugated with colloid gold and mouse IgG-gold conjugates. When the processed buffer containing the sample is added to the sample well, COVID-19 (SARS-CoV-2) will combine with the COVID-19 antibody conjugate to form an antigen-antibody complex. This complex migrates through nitrocel- lulose membrane by capillary action. When the complex meets the line of the COVID-19 antibody of test line T, the complex is trapped forming a burgundy colored band which confirms a reactive test result. Absence of a colored band in the test region indicates a non-reactive test result.
The test contains an internal control (C band) which should exhibit a burgundy colored band of the immunocom- plex goat anti-mouse IgG/mouse IgG-gold conjugate regardless of the color development on any of the test bands. Otherwise, the test result is invalid and the specimen must be retested with another device.
MATERIALS COMPOSITION
COVID-19 antibody of Nucleocapsid protein
Goat anti-mouse IgG
Mouse IgG
Nitrocellulose membrane
MATERIALS SUPPLIED
Sealed pouches each containing a test cassette, a desiccant
Sampling cotton swabs (for nasal cavity sampling only)
Antigen extract buffer
Antigen extraction tube
Paper workbench (The small one-test-box can be used as a workbench)
Instructions for use
MATERIALS REQUIRED BUT NOT PROVIDED
Timer
STORAGE AND STABILITY
The kit can be stored at 4-30°C. The test device is stable through the expiration date printed on the sealed pouch. The test device must remain in the sealed pouch until use.
Do not freeze.
Do not use after expiry
WARNINGS AND PRECAUTIONS
• Use the test kit once only. Do not reuse the test strip or buffer.
• Do not use the kit if the pouch/tube is damaged or broken.
• Remove the test device from the sealed pouch only when you are ready to perform the test.
• Use only the components of this test kit.
• Inadequate or improper sample collection may lead to inaccurate or false results.
• Avoid contact with skin and eyes. In case of accidental contact, rinse well. In case of concerns, consult your doctor.
• Keep the test kit away from children to reduce the risk of accidentally drinking the buffer or swallowing small parts.
• This test is for presumptive screening only. Please consult a doctor to discuss your test result and to find out whether additional test are needed. Please also consult a doctor if you have any concerns about your health, if you are experiencing prolonged symptoms, or if your symptoms are worsening.
• If your test result is positive refer to you state or territory health department information for guidance on confirmation testing, where necessary. Consult your doctor for any follow-up clinical care.
• Even if your test result is negative, continue to observe all applicable hygiene and safety measures. Even with a negative result, you may still be infectious.
• Repeat testing is recommended (e.g. within 1-3 days) if there is an ongoing suspicion of infection, being in a high risk setting or where is an occupational risk or other requirement.
SPECIMEN COLLECTION
• COVID-19 Test kit (Colloidal Gold Method) can be performed using nasal cavity sampling.
• Testing should be performed immediately after specimen collection.
TEST PROCEDURE
Preparing for a test
1. Wash your hands with soap and water or use a hand sanitizer before performing the test.
2. Allow test cassette, specimen and Antigen extract buffer to equilibrate to room temperature (15-25°C) prior to testing.
3. Carefully read the Instructions for Use before performing the test.
Collecting and preparing a nasal sample
1. Place the antigen extraction tube on the workbench and open the tube cover.
2. Open the antigen extraction buffer bottle and Place vertically downward, squeeze the bottle to make the buffer drip freely into the extraction tube without touching the edge of the tube, and add 6 drops (about 200ul) to the extraction tube.
3. Remove the swab from the packaging. Ensure that you only touch the handle of the swab and not the soft pad and the tip.
4. Slightly tilt your head backwards.
5. Remove the secretions on the surface of the anterior nasal cavity, keep the head slightly tilted, and gently and slowly insert the swab through the nasal cavity (about 2-4cm), Rotate the swab 5 times against the lining of the nasal wall, and gently rotate to remove the swab.
6. Insert the swab into an extraction tube pre-added with the antigen extraction buffer, and rotate the swab about 10 times while
pressing the swab head against the tube wall to release the antigen in the swab, then let it stand for about 1 minute.
7. Remove the swab while squeezing the tip of the swab to extract the liquid from the swab.
8. Install the dripper on the extraction tube and cap it tightly, and let it stand for about 1 minute.
Performing the test
1. Remove the test cassette from the sealed foil pouch and use it as soon as possible. If not used immediately, the test much be used within 1 hour after opening.
2. Place the test device on a clean and level surface.
3. Add 3 drops of extracted solution into the specimen well, and start the timer.
4. Wait for the colored line to appear. The result should be read in 15 minutes. Do not interpret the result after 20 minutes.
5. Wash your hands with soap and water or use a hand sanitizer after performing the test.
Procedures After Result Interpretation
1. Use a household bleach spray or a 70%-75% alcohol spray to disinfect used product components.
2. Put used product components in a plastic bag. Close the bag and put it in another plastic bag. Dispose of the bag in accordance with biohazard waste disposal methods.
3. Wash the hands thoroughly with soap or use hand sanitizer.
INTERPRETATION OF RESULTS
NEGATIVE:
If only the C band is present, the absence of any burgundy color in the T band indicates that no COVID-19 (SARS-CoV-2) antigen is detected in the specimen. The result is negative.
If the test result is negative:
Continue to follow all applicable rules regarding contact with others and protective measures. Even if the test is negative, an infection may be present.
In case of suspicion, repeat the test after 1 - 2 days, because the Coronavirus cannot be accurately detected at all stages of infection.
COVID-19 positive:
If the C and T band are present, the test indicates for the presence of COVID-19 (SARS-CoV-2) antigen in the specimen.
The result is COVID-19 positive.
There is currently a suspicion of a COVID-19 infection
• Contact physician/family physician or local health department immediately
• Follow local guidelines for self-isolation
• Have a PCR confirmatory test performed.
Look out for weak/faint line as positive, to follow up a positive result with a PCR test.
Refer to your relevant health authority for advice on whether a PCR test is required to confirm your result.
INVALID:
Control line(C) fails to appear. 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 cassette. If the problem persists, discontinue using the test kit immediately and contact your local distributor.
In case of an invalid test result:
• Possibly advance warning due to incorrect test performance.
• Repeat the test
• If test results are still invalid, contact a physician or a COVID-19- Test Center.
LIMITATIONS
• Use fresh samples whenever possible.
• Optimal assay performance requires strict adherence to the assay procedure described in this insert sheet. Deviations may lead to aberrant results.
• Negative results do not rule out a SARS-CoV-2 infection and should not be used as the sole basis for treatment or patient management decisions, including decisions about infection control. Individuals who have tested negative and continue to show COVID-19-like symptoms should contact their doctor/primary care physician.
• The test kit provides a self-assessment. A conformed diagnosis should only be made by a physician after all clinical and laboratory findings have been evaluated.
• Only use for in vitro diagnostic, and cannot reused.
• Positive results do not exclude the possibility that a bacterial infection or a co-infection with another virus is present.
• Positive results indicate the presence of viral antigens. However, a clinical correlation with the case history and other diagnostic information are required to determine the status of the infection.
• False negative test results (i.e., an existing infection is not detected) may occur if testing is not performed within the first 7 days of symptom onset as the antigen level in the specimen may be too low.
• False negative test results may occur if the specimen was collected incorrectly.
• False negative test results may occur if the specimen swab is not mixed well in the tube.
• False positive results may occur in the presence of SARS-CoV infections.
• Negative results should be viewed as provisional and a PCR test should be performed as confirmation if necessary.
• The test should be used for the detection of COVID-19 antigen in human nasal swab.
• This product is mainly used for self-testing of aged 18-60. Usage for minors or seniors is recommended under adults supervision.
PERFORMANCE CHARACTERISTICS
1. Clinical Sensitivity, Specificity and Accuracy
The results of the COVID-19 Test Kit (Colloidal Gold Method) were compared to results of RT-PCR assays for SARS-CoV-2 in nasal swab specimens. A total of 560 nasal swabs samples were tested in this study. 110 nasal swabs samples from RT-PCR confirmed SARS-CoV-2 positive cases (from early infection within the first 7 days after symptom onset), include 5 nasal swabs samples containing the Delta viral mutant (B.1.617.2). 450 nasal swabs samples from RT-PCR confirmed COVID-19 negative cases, include 300 non-infected individuals, 100 from hospitalized patients and 50 of potentially interfering and cross-reactive samples. The sensitivity and specificity calculated were valid in this study.
（Youtube Video for TEST PROCEDURE）
https://www.youtube.com/watch?v=5ecp8iwmeSE
Version: 8.129.04.349-A0 Issued date: 2022-01-27
