CLUNGENE COVID-19 Rapid Test.
Note: the ‘specimen’ is blood from the finger prick
Allow the test device and specimens to equilibrate to temperature (15-30°C or 59-86°F) prior to testing.
- Remove the test cassette from the sealed pouch.
- Hold the dropper vertically and transfer 1 drop of the specimen (approximately 10ul) to the specimen well(S) of the test device, then add 2 drops of buffer (approximately 70pl) and start the timer.
- Wait for colored lines to appear. Interpret the test results in 15 minutes. Do not read results after 20 minutes.
INTERPRETATION OF THE RESULTS.
Positive: Control line and at least one test line appear on the membrane. The appearance of the IgG test line indicates the presence of Novel coronavirus specific to IgG antibodies.
The appearance of the IgM test line indicates the presence of Novel coronavirus IgM antibodies. And if both IgG and IgM line appears, it indicates that the presence of both Novel coronaviruses specific to IgG and IgM antibodies.
Negative: One colored line appears in the control region (C). No apparent colored line appears in the test line region.
Invalid: The Control line 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 testing kit immediately and contact your local distributor.
A procedural control is included in the test. A colored line appearing in the control region (C) is considered an internal procedural control. It confirms sufficient specimen volume, adequate membrane wicking, and correct procedural technique. Control standards are not supplied with this kit. However, it is recommended that positive and negative controls be tested as good as laboratory practices to confirm the test procedure and to verify proper test performance.
- The COVID-19 IgG and IgM Rapid Test Cassette are limited to provide qualitative detection. The intensity of the test does not necessarily correlate to the concentration of the antibody in the blood.
- The results obtained from this test are intended to be an aid to diagnosis only. Each physician must interpret the results in conjunction with the patient’s history, physical findings, and other diagnostic procedures.
- A negative test result indicates that antibodies to Novel coronavirus are either not present or at levels undetectable by the test.
The COVID-19 IgG/IgM Rapid Test Cassette is a lateral flow chromatographic immunoassay for the qualitative detection of antibodies (IgG and IgM) to Novem Coronavirus in human Whole Blood/Serum/Plasma. It provides an aid in the diagnosis of infection with Novel coronavirus.
The COVID-19 IgG/IgM Rapid Test Cassette is a qualitative membrane strip based immunoassay for the detection of antibodies (IgG/IgM) to Novel coronavirus in human Whole Blood/Serum/Plasma. The test cassette consists of
1) a burgundy-colored conjugate pad containing Novel coronavirus recombinant envelope antigens conjugated with Colloid gold (Novel coronavirus conjugates)
2) a nitrocellulose membrane strip containing two test lines (IgG and IgM lines) and a control line (C line). The IgG line is coated with Mouse anti-Human IgG antibody. When an adequate volume of the test specimen is dispensed into the sample well of the test cassette, the specimen migrates by capillary action across the cassette. IgM anti-Novel coronavirus, if present in the specimen, will bind to the Novel coronavirus conjugates. The immunocomplex is then captured by the reagent pre-coated on the IgM band, forming a burgundy colored IgM line, indicating a Novel coronavirus IgM positive test result. IgG anti-Novel coronavirus if present in the specimen, will bind to the Novel-coronavirus conjugates. The immunocomplex is then captured by the reagent coated on the IgG line, forming a burgundy coloured IgG line, indicating a Novel coronavirus IgG test result. The absence of any T lines (IgG and IgM) suggests a negative result. To serve as a procedural control, a coloured line will always appear at the control line region indicating that proper volume of specimen has been added and membrane wicking has occurred.
Warnings and Precautions
- For in vitro diagnostic use only.
- Do not use after the expiration date.
- Please read all the information in this leaflet before performing the test.
- The test cassette should remain in the sealed pouch until use.
- All specimens should be considered potentially hazardous and handled in the same manner as an infectious agent.
- The used test cassette should be discarded according to federal, state and local regulations.
STORAGE AND STABILITY
- Store as packaged in the sealed pouch at the temperature (4-30C or 40-86’F). The kit is stable within the expiration date printed on the labeling.
- Once open the pouch, the test should be used within one hour. Prolonged exposure to the hot and humid environment will cause product deterioration.
- The LOT and the expiration date were printed on the labeling.
- The test can be used to test Whole Blood/Serum/Plasma specimens.
- To collect whole blood, serum or plasma specimens following regular clinical laboratory procedures.
- Separate serum or plasma from blood as soon as possible to avoid hemolysis. Use only clear non-hemolyzed specimens.
- Store specimens at 2-8C (36-46F) if not tested immediately. Store specimens at -20C 2-8C to 7 days. The specimens should be frozen at (4F) for longer storage. Do not freeze whole blood specimens.
- Avoid multiple freeze-thaw cycles. Prior to testing, bring frozen specimens to room temperature slowly and mix gently. Specimens containing visible particulate matter should be clarified by centrifugation before testing.
- Do not use samples demonstrating gross lipemia, gross hemolysis or turbidity in order to avoid interference on result interpretation.