COVID-19 and Influenza AB Antigen Test Kit for self-testing
Detailed Description
The LYHER® COVID-19 and Influenza A/B Antigen Test Kit for self-testing is an in vitro immunoassay. The assay is for the direct and qualitative detection of antigen of SARS-CoV-2 and Influenza A/B from nasal swab. The kit is for in vitro diagnostic use by non-professionals only.This test is authorized for non-prescription home use with self-collected nasal swab specimens directly from individuals aged 14-70 years. For individuals who are aged 2 -13 years and older than 70 years, the test shall be carried out by an adult or under the help of an adult.
In individuals without COVID-19 and Influenza A/B symptoms and/or individuals who live in areas with low numbers of COVID-19 and Influenza A/B infections and without known exposure to COVID-19 and Influenza A/B, more false positive results may be returned. Testing of individuals without symptoms should be limited to contacts of confirmed or probable cases or to other epidemiological reasons to suspect a COVID-19 and Influenza A/B infection and should be followed by additional confirmatory testing with a molecular test.
Contents
A kit contains:
Package specifications: 1 T/kit, 2 T/kit, 5 T/kit, 25 T/kit
1) COVID-19 and Influenza AB Antigen test Cassette
2) Extraction tube with sample extraction solution and tip
3) Cotton swab
4) IFU: 1 piece/kit
5) tubu stand: 1 piece/kit
Additional required material: clock/ timer/ stopwatch
Note: Do not mix or interchange different batches of kits.
Specifications
Test Item | Sample Type | Storage Condition |
COVID-19 and Influenza AB Antigen | nasal swab | 2-30℃ |
Methodology | Test Time | Shelf Life |
Colloidal Gold | 15mins | 24 months |
Operation
01. Insert the cotton swab into a nostril gently. Insert the tip of the cotton swab 2-4 cm (for children is 1-2 cm) until resistance is felt.
02. Swirl the cotton swab along the nasal mucosa 5 times within 7-10 seconds to ensure that both mucus and cells are absorbed.
03. Dip the head of the cotton swab into the diluent after taking the sample from the nose.
04. Squeeze the sample tube with a cotton swab 10-15 times to mix evenly so that the wall of the sample tube touches the cotton swab.
05. Keep it upright for 1 minute to keep as much sample material as possible in the diluent. Discard the cotton swab. Place the dropper on the test tube.
TEST PROCEDURE
06. Add the sample as follows. Place a clean dropper on the sample tube. Invert the sample tube so that it is perpendicular to the sample hole (S).Add 3 DROPS of the sample into each sample hole.
07. Set the timer for 15 MINUTES.
08. Read the result after 15 MINUTES
INTERPRETATION
POSITIVE: Two colored lines appear on the membrane. One line appears in the control region (C) and the other line appears in the test
NEGATIVE: Only one colored line appears in the control region (C). No apparent colored line appears in the test region (T).
INVALID: Control line fails to appear.
CAUTION
1. The color intensity in the test region (T) may vary depending on the concentration of virus proteins present in the nasal mucus sample. Therefore, any color in the test region should be considered positive. It should be noted that this is only a qualitative test and cannot determine the concentration of viral proteins in the nasal mucus sample.
2. Insufficient sample volume, improper procedure or expired tests are the most likely reasons why the control line does not appear.
Clinical Performance
Table 1: COVID-19Rapid Test vs. RT-PCR
Sensitivity: 93.67% , Specificity: more than 99% , Accuracy: 98.77%
Table 2: Influenza A Test vs. RT-PCR
Table 3: Influenza B Test vs. RT-PCR
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