Coronavirus lgM Rapid Test

Koronavírus gyorsteszt

INTRODUCTION

The COVID-19 IgM rapid test kit is used to detect the lgM antibody to severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in human serum, plasma or whole blood sample qualitatively. The coronavirus IgM rapid test is to be used as an aid in the diagnosis of coronavirus infection disease (COVID-19), which is caused by SARS-CoV-2.

This product is not available anymore.

Our SARS-CoV-2 Antigen Rapid Tests are still available HERE and our SARS-CoV-2 IgM/IgG Rapid Tests are available HERE!

 

Specification

Product Name:
SARS-CoV-2 lgM Antibody Rapid Test (lmmunochromatography)

Specimen: WB/S/P
Kit size: 25T/Box
Format: Cassette
Positive coincident rate: 82%
Negative coincident rate: 96%
Total coincidence rate: 92.8%
Manufacturer: Qingdao Hightop Biotech Co., Ltd.

Coronavirus IgM Rapid Test Principle

The COVID-19 IgM rapid test kit is an immunochromatographic assay, using capture method for rapid, qualitative detection of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) lgM antibody in human serum, plasma or whole blood sample. When the sample contains the SARS-CoV-2 lgM antibody, it forms a complex with the gold label antigen (SARS-CoV-2 recombinant antigen). The complex moves forward under the action of chromatography and combines with the coated antibody (Mouse anti-human lgM monoclonal antibody) at the T line to form a complex and develop color (T line), which is a positive result.

When the sample does not contain the SARS-CoV-2 lgM antibody, no complex can be formed at the T line, and no red band appears, which is a negative result. Regardless of whether the SARS-CoV-2 lgM antibody is contained in the sample, the gold label quality control antibody (rabbit lgG antibody) will bind with the coated antibody (goat anti-rabbit lgG antibody) at the C line to form a complex and develop color (C line).

Main Components of the coronavirus IgM rapid test kit

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Cassette: T-line coated with mouse anti-human lgM monoclonal antibody, gold label pad solid phase SARS-CoV-2 recombinant antigen, rabbit lgG antibody, C-line coated with goat anti-rabbit lgG antibody.

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Sample dilution: composed of 20 mM phosphate buffer solution (PBS)

Attentions

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The coronavirus IgM rapid test kit is for IN VITRO diagnostic use only.

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Reagents should be used as soon as possible after opened. This reagent cannot be reused for disposable.

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The coronavirus IgM rapid test device should remain in the sealed pouches until use. If sealing problem happens, do not test. Don't use after the expiration date.

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AII specimens and reagents should be considered potentially hazardous and handled in the same manner as an infectious agent after use.

COVID-19 IgM rapid test methods

For Serum/Plasma

Covid-19 rapid test first step

1.

Add one (1) full drop of serum or plasma (10μl) vertically into the sample well.

Covid-19 rapid test second step

2.

Add two (2) drops (80-100μl) of sample buffer into the sample well.

Covid-19 rapid test result

3.

Observe the test results immediately within 15~20 minutes, the result is
invalid over 20 minutes.

For Whole Blood

Covid-19 rapid test first step

1.

Add two (2) full drops of whole blood (20μl) vertically into the sample well.

Covid-19 rapid test second step

2.

Add two (2) drops {80-100μl) of sample buffer into the sample well.

Covid-19 rapid test result

3.

Observe the test results immediately within 15~20 minutes, the result is
invalid over 20 minutes.

Interpretation of results

POSITIVE

Two distinct red lines appear. One line should be in the control region (C) and the other line should be in the test region (T).

NEGATIVE

One red line appears in the control region (C). No red or pink line appears in the test region (T).

INVALID

No red lines appear or control line fails to appear, indicating that the operator error or reagent failure. Verify the test procedure and repeat the test with a new testing device.

Performance characteristics of the Coronavirus IgM rapid test

P

Positive coincidence rate: 82%

O

Negative coincidence rate: 96%

Sample requirement

The reagent can be used for the serum, plasma and whole blood samples.

A serum/ plasma/ whole blood sample must be collected in a clean and dry container. EDTA, sodium citrate, heparin can be used as anticoagulants in plasma/ whole blood samples. Detect irtimediately after collecting blood.

Serum and plasma samples may be stored at 2-8°C for 3 days prior to assay. If testing is delayed more than 3 days, the sample should be frozen (-20°C or colder). Repeat freeze and thaw for no more than 3 times

Whole blood samples with anticoagulant can be stored at 2-8°C for 3 days, and should not be frozen; whole blood samples without anticoagulant should be used immediately (if the sample has agglutination, it can be detected by serum).

Limitations of the COVID-19 IgM rapid test

This reagent is designed for the qualitative screening test. Concentration of SARS-CoV-2 lgM antibody cannot be determined by this coronavirus IgM rapid test. The depth of the T-line color is not necessarily related to the concentration of the antibody in the sample.

The results of the reagent are only for clinical reference, which is not the only basis for clinical diagnosis and treatment. A confirmed diagnosis and treatment should only be made by a· physician after all clinical and laboratory findings have been evaluated.