Novel Coronavirus (COVID-19) Antigen Test Kit (Colloidal Gold)
Detailed Description
INTENDED USE
The LYHER® Novel Coronavirus (COVID-19) Antigen Test Kit (Colloidal Gold) is an in vitro immunoassay. The assay is for the direct and qualitative detection of antigen (N-protein) of SARS-CoV-2 from Nasal swab specimens. The kit is for in vitro diagnostic use. For professional use only.
About COVID-19
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.
Contents
Package specifications: 25 T/kit
1) SARS-CoV-2 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 |
| SARS-CoV-2 antigen | nasal swab | 2-30℃ |
| Methodology | Test Time | Shelf Life |
| Colloidal Gold | 15mins | 24 months |
Operation
1. Collection of Specimens:
Nasal Swab: Make sure the nasal cavity is moist, then Carefully insert the swab into one nostril of the patient. The swab tip should be inserted up to 2-4 cm until resistance is met. Roll the swab 5 times along the mucosa inside the nostril to ensure that both mucus and cells are collected. Using the same swab, repeat this process for the other nostril to ensure that an adequate sample is collected from both nasal cavities. Withdraw the swab from the nasal cavity.
Treatment of Specimen: Tear off the buffer seal, insert the swab head into the extraction buffer after specimen collection, mix well, squeeze the swab 10-15 times by compressing the walls of the tube against the swab, and let it stand for 1 minute to keep as many samples as possible in the specimen extraction buffer. Discard the swab.
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 region (T).
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. Results from any test which has not produced a control line 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 line failure.
Clinical Performance
Sensitivity: 85.48% Specificity: 99.52% Accuracy: 92.88%
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