Product Advantage

  • ● High detection accuracy
  • ● Quality assurance
  • ● Easy to perform and read
  • ● Fast result in 15 mins
  • ● Convenient: room temperaturestorage

Certificate

CE Marked

Approved in Vietnam, Thailand, Malaysia

INTENDED USE

The LYHER® Respiratory Multiple Rapid Test (FluA/FluB/COVID-19/RSV) is a lateral flow immunoassay intended for the qualitative detection of nucleocapsid protein antigen from SARS-CoV-2, influenza A virus, influenza B virus or respiratory syncytial virus (RSV) in nasopharyngeal swab or nasal swab specimens. This test only provides an aid to diagnosis. The infection status should be determined in combination with other diagnostic information such as PCR tests or medical image science, exposures and medical history.


Package Specifications

  1.  1T/kit, 5T/kit, 20T/kit, 25T/kit, 40T/kit

    Test(s) per kit

    1x

    5x

    20x

    25x

    40x

    Test Cassette

    1x

    5x

    20x

    25x

    40x

    Extraction Buffer Tube (0.55 mL/tube)

    1x

    5x

    20x

    25x

    40x

    Sterile Swab

    1x

    5x

    20x

    25x

    40x

    Instructions for Use

    1x

    1x

    1x

    1x

    1x

    Tube Holder

    /

    (as packing)

    1x

    1x

    1x

    1x



Test Procedure

 

 

Remove the seal from the tube.

Place specimen tube in workbench or tube stand.

Insert the swab gently into your nostril. Insert the tip of the swab 2-4 cm (for children is 1-2 cm) until resistance is felt.

 

 

 

Roll the swab along the inside of one nostril 5 times within 7-10 seconds. Repeat this in the other nostril. 

Remove the swab from your nostril and insert swab tip into the liquid inside the tube.

Squeeze the sample tube with the swab inserted 10-15 times to mix.

 

 

 

Keep the tube upright with the swab inserted for 1 minute.

Shake the tube 3 to 5 times and add 3 drops (about 100ul) to each sample hole (S).

Wait for 15 minutes and read the result.


Interpretation of Results

 

For COVID-19/RSV antigen rapid test

 

 

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 FluA/FluB antigen rapid test

 

Influenza A POSITIVE: 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: 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: Tree 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).INVALID: Control line fails to appear.

 

Clinical Performance

  1. 1. Total results of LYHER kits

Sensitivity: 95.45% , Specificity: 100% , Accuracy: 98.07%

  1. 2. Results of COVID-19 Test vs. RT-PCR

Sensitivity: 96.23% , Specificity: 100% , Accuracy: 99.32%

  1. 3. Results of Influenza A Test vs. RT-PCR

Sensitivity: 96.88% , Specificity: 100% , Accuracy: 99.66%

  1. 4. Results of Influenza B Test vs. RT-PCR

Sensitivity: 94.44%, Specificity: 100% , Accuracy: 99.66%

  1. 5. Results of RSV Test vs. RT-PCR

Sensitivity: 96.23%, Specificity: 100% , Accuracy: 99.32%