The LYHER® COVID-19 and Influenza A/B Antigen Test Kit 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 nasopharyngeal secretions and oropharyngeal secretions. The kit is for in vitro diagnostic use.
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.
A kit contains
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.
|Test Item||Sample Type||Storage Condition|
|antigen of SARS-CoV-2 and Influenza A/B||Nasopharyngeal swab/oropharyngeal swab||2-30℃|
|Methodology||Test Time||Shelf Life|
|Colloidal Gold||15mins||24 months|
Specimen Collection and Storage
1.This product can be used for nasopharyngeal or oropharyngeal swab samples. Nasopharyngeal swab specimens are recommended strongly.
2.Protective measures shall be taken when collecting specimens and the specimens shall be collected in accordance with the licensed collection techniques.
3.Before collecting specimen, ensure that the specimen tube is sealed and the extraction buffer does not leak out. Then tear the seal off the tube pre-filled with buffer and gently place it on the tube stand.
4.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 1 minute to keep as many samples as possible in the specimen extraction buffer. Discard the swab.
5.Swab specimens should be tested as soon as possible after collection. Use freshly collected specimens for best test performance.
6.If not tested immediately, the swab specimens can be stored between 2-8°C for 4 hours after collection or be stored at room temperature for 1 hour. If long-term storage is required, it should be kept at -70℃ to avoid repeated freeze-thaw cycles.
7.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.
1.1The specimens to be tested and the required reagents shall be removed from the storage condition and be balanced to room temperature;
1.2The kit shall be removed from the packaging bag and placed flat on a dry bench.
2.1 Place the test kit horizontally on the table.
2.2 Add specimen
Place the clean dropper tip on the specimen tube and invert the specimen tube so that it is perpendicular to the sample well (S) and add 3 drops (about 100 μl ) of the sample for each sample well (S). Set timer for 15 minutes.
2.3 Reading the result
The positive specimens can be detected at 15 minutes after specimen 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
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.
For Influenza A/B
Influenza A POSITIVE: It is positive for Influenza A antigen if two Red lines appear. One Red line should be in the control line region (C), and the other one appears in the A test line region.
Influenza B POSITIVE: It is positive for Influenza B antigen if two Red lines appear. One red line should be in the control line region (C), and the other one appears in the B test line region.
Influenza A and B POSITIVE: It is positive for both the antigens of Influenza A and Influenza B if three Red lines appear. One Red line should be in the control line region (C), and another two should appear in A test line region and B test line region.
NEGATIVE: One Red line appears in the control region (C). No apparent red line appears in the influenza A and B test region (T).
Table 1-1: Lyher Test Kit - COVID-19
Sensitivity: 96.23% Specificity: 100% Accuracy: 98.96%
Table 1-2: Lyher Test Kit - Influenza A
Sensitivity: 100% Specificity: 100% Accuracy: 100%
Table 1-3: Lyher Test Kit - Inluenza B
Sensitivity: 94.44% Specificity: 100% Accuracy: 99.48%