Rapid Test Kit
Compact & Fully-Automated Bench Top Analyzer
LYHER Novel coronavirus (COVID-19) Antigen test kit (COLLOIDAL GOLD)
Vitro Immunoassay (Sample Type - Saliva)
Sample type :
- Saliva
Product Advantage :
- High Detection accuracy
- High cost performance
- Quality assurance
- Fast delivery
Clinical Performance
Sensitivity
95.58%
Specificity
99.47%
Accuracy
98.01%
Low Consumption
Only need three reagents. Sample consumed ≤20uL
Efficient
60 samples per hour
Lightweight
390mm(L)×285mm(W)×390mm(H) Weight≤16Kg
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
- SARS-CoV-2 antigen test Cassette
- Extraction tube with sample extraction solution and tip
- Disposable dropper
- IFU: 25 piece/kit
- tubu stand: 1 piece/kit
- 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
● SARS-CoV-2 antigen
● Methodology
● Colloidal Gold
● Saliva
● Test Time
● 15mins
● 2-30℃
● Shelf Life
● 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.
Compact & Fully-Automated Bench Top Analyzer
LYHER Novel coronavirus (COVID-19) Antigen test kit
Vitro Immunoassay (Sample Type - Nasopharyngeal & Oropharyngeal Swab)
Sample type :
- Nasopharyngeal & Oropharyngeal Swab
Product Advantage :
- High Detection accuracy
- High cost performance
- Quality assurance
- Fast delivery
Clinical Performance
Sensitivity
95.07%
Specificity
99.54%
Accuracy
98.12%
Low Consumption
Only need three reagents. Sample consumed ≤20uL
Efficient
60 samples per hour
Lightweight
390mm(L)×285mm(W)×390mm(H) Weight≤16Kg
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
- SARS-CoV-2 antigen test Cassette
- Extraction tube with sample extraction solution and tip
- Cotton swab
- IFU: 1 piece/kit
- tubu stand: 1 piece/kit
- Additional required material: clock/ timer/ stopwatch
- Note: Do not mix or interchange different batches of kits.
Specifications
● SARS-CoV-2 antigen
● Methodology
● Colloidal Gold
● Nasopharyngeal swab/oropharyngeal swab
● Test Time
● 15mins
● 2-30℃
● Shelf Life
● 24 months
Operation
Specimen Collection and Storage
- Handle all specimens as if they are capable of transmitting infectious agents.
- 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.
- Swab specimens should be tested as soon as possible after collection. Use freshly collected specimens for best test performance.
- 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.
- 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
- 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.
- Insufficient sample volume, improper procedure or expired tests are the most likely reasons why the control line does not appear.