LYHER Novel coronavirus (COVID-19) Antigen test kit (Colloidal Gold)
Sample type:
-
saliva
Product Advantage:
- High Detection accuracy
- High cost performance
- Quality assurance
- Fast delivery
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 sputum or saliva specimens. The kit is for in vitro diagnostic use.
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) Disposable dropper
4) IFU: 25 piece/kit
5) tubu stand: 1 piece/kit
6) Paper cup: 25 piece/kit
Additional required material: clock/ timer/ stopwatch
Note: Do not mix or interchange different batches of kits.
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 | saliva | 2-30℃ |
| Methodology | Test Time | Shelf Life |
| Colloidal Gold | 15mins | 24 months |
Test Procedure
Preparing
The specimens to be tested and the required reagents shall be removed from the storage condition and be balanced to room temperature;
The kit shall be removed from the packaging bag and placed flat on a dry bench.
Testing
2.1 Place the test kit horizontally on the table.
2.2 Add specimen
Shaking the tube 3 to 5 times and invert the tube so that it is perpendicular to the sample hole (S) and add 3 drops (about 100ul ) of the sample. Set timer for 15 minutes.
2.3 Reading the result
The positive specimens can be detected at 15 minutes after sample addition.
Interpretation of Results
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: 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. Insufficient specimen volume, incorrect operating procedure or expired tests are the most likely reasons for control line failure.
Clinnical Performance
Sensitivity: 95.58% Specificity: 99.47% Accuracy: 98.01%
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