Novel Coronavirus (COVID-19) Antigen Test Kit (Colloidal Gold) – Nasopharyngeal,oropharyngeal
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 of SARS-CoV-2 from nasopharyngeal secretions and oropharyngeal secretions 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) 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 | Nasopharyngeal swab/oropharyngeal swab | 2-30℃ |
| Methodology | Test Time | Shelf Life |
| Colloidal Gold | 15mins | 24 months |
Operation
Specimen Collection and Storage
1.Handle all specimens as if they are capable of transmitting infectious agents.
2.Before collecting specimen, ensure that the specimen tube is sealed and the extraction buffer does not leak out. Then tear off its sealing film and be on standby.
3.Collection of Specimens:
- Oropharyngeal specimen: With the patient's head slightly lifted up, and the mouth wide open, the patient's tonsils are exposed. With a clean swab, the patient's tonsils are gently rubbed back and forth at least 3 times, and then the patient's posterior pharyngeal wall are rubbed back and forth at least 3 times.
- Nasopharyngeal specimen: Let the patient's head relax naturally. Turn the swab against the wall of the nostril slowly into the nostril, to the nasal palate, and then rotate while wiping and remove slowly.
Treatment of Specimen: 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 2 minutes to keep as many samples as possible in the specimen extraction buffer. Discard the swab handle.
4.Swab specimens should be tested as soon as possible after collection. Use freshly collected specimens for best test performance.
5.If not tested immediately, swab specimens may be stored at 2-8°C for 24 hours after collection. If long-term storage is required, it should be kept at -70℃ to avoid repeated freeze-thaw cycles.
6.Do not use specimens that are obviously contaminate with blood, as it may interfere with the flow of sample with the interpretation of test results.
Test Procedure
1.Preparing
1.1 The specimens to be tested and the required reagents shall be removed from the storage condition and be balanced to room temperature;
1.2 The kit shall be removed from the packaging bag and placed flat on a dry bench.
2.Testing
2.1 Place the test kit horizontally on the table.
2.2 Add specimen
Insert the clean dropper tip on the specimen tube and invert the specimen 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 colored line appears in the control region (C) and the other line appears in the test region (T).
NEGATIVE: Only a single colored line appears in the control region (C). No visible colored line appears in the test region (T).
INVALID: The control line does not appear. The tests results which do not show a control line after the specified reading time should be discarded. The sample collection should be checked and repeated with a new test. Stop using the test kit immediately and contact your local dealer if the problem persists.
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
Sensitivity: 95.07% Specificity: 99.74% Accuracy: 98.12%
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