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SARS-CoV-2 Antigen Rapid Test Kit for self-testing (Saliva)


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Product Advantage:

  • High Detection accuracy
  • High cost performance
  • Quality assurance
  • Fast delivery

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Detailed Description

Intended Use

The LYHER® SARS-CoV-2 Antigen Rapid Test Kit for self-testing (Saliva) is an in vitro immunoassay. The assay is for the direct and qualitative detection of antigen(N-protein) of SARS-CoV-2 from saliva specimens. The kit is for in vitro diagnostic use by non-professionals.This test is authorized for non-prescription home use with self-collected saliva specimens directly from individuals aged 14-70 years. For individuals who are aged 2 -13 years and older than 70 years, the test shall be carried out by an adult or under the help of an adult.
In individuals without COVID-19 symptoms and/or individuals who live in areas with low numbers of COVID-19 infections and without known exposure to COVID-19, more false positive results may be returned. Testing of individuals without symptoms should be limited to contacts of confirmed or probable cases or to other epidemiological reasons to suspect a COVID-19 infection and should be followed by additional confirmatory testing with a
molecular test.

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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.

Use this test:

- If you want to test yourself.
- If you have symptoms similar to COVID-19, such as headache, fever, cough, sore throat, loss of the sense of smell or taste, shortness of breath, muscle pain.
- If you are concerned about whether you are infected with COVID-19.
- Use of the test by persons under 16years of age only under the supervision of an adult.

Contents:

A kit contains:
Package specifications: 1 T/kit, 5 T/kit, 7 T/kit, 25 T/kit
1) Test device
2) Buffer with dropper tip
3) Paper Cup
4)Disposable dropper
5) 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 Saliva 2-30℃
Methodology Test Time Shelf Life
Colloidal Gold 15mins 24 months

Operation

qw (1)

01. Rinse and spit with water.
02. Cough deeply,make the noise of “Kruuua” from the throat to clear sputum/oropharyngeal saliva from deep throat.
03. Release it into the container once the sputum/oropharyngeal saliva is in your mouth.
04. Suction 200 microliters through dropper
05. Into the specimen tube

qw (2)

06. Cover the sample tube tightly and shake the sample tube about 10 times
07. Let stand for 1 minute
08. Add the sample as follows. Place a clean dropper on the sample tube. Invert the sample tube so that it is perpendicular to the sample hole (S).Add 3 DROPS of the sample.
09. Set the timer for 15 MINUTES.

INTERPRETATION

qw (3)

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.