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SARS-CoV-2 (COVID-19) IgM/IgG Antibody Rapid Test Kit (25 pcs/kit)

Hightop Biotech SARS-CoV-2 IgM/IgG Antibody Rapid Test

INTRODUCTION

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

Our product is in stock.

Discount price:

104,30

/25 tests

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Specification

Product name:
SARS-CoV-2 IgM/IgG Antibody Rapid Test

Specimen: Whole Blood/Serum/Plasma
Kit size: 25 Tests/Box
Format: Cassette
Manufacturer: Hightop Biotech Co., Ltd.

Main components

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Test cassettes (25 pcs): T1-line coated with mouse anti-human lgG monoclonal antibody, T2-line coated with mouse anti-human lgM monoclonal antibody, gold label pad solid phase SARS-CoV-2 recombinant antigen, Biotinylated BSA, C-line coated with streptavidin-conjugated lgG

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Sample dilution (25 pcs): composed of 20 mM phosphate buffer solution (PBS)

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Disposable plastic straws (25 pcs)

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Alcohol pads (25 pcs)

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Sterile lancets (25 pcs)

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Instruction

Test Principle

This kit is an immunochromatographic assay, using capture method for rapid, qualitative detection of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) lgM/lgG 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 T2 line to form a complex and develop color (T2 line), which indicates a positive result. When the sample does not contain the SARS-CoV-2 lgM antibody, no complex can be formed at the T2 line, and no red band appears, which indicates a negative result.

When the sample contains the SARS-CoV-2 lgG 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 lgG monoclonal antibody) at the T1 line to form a complex and develop color (T1 line), which indicates a positive result. When the sample does not contain the SARS-CoV-2 lgG antibody, no complex can be formed at the T1 line, and no red band appears, which indicates a negative result.

Regardless of whether the SARS-CoV-2 lgM and/or lgG antibody is contained in the sample, the gold label quality control antibody (Biotinylated BSA) will bind with the coated antibody at the Cline to form a complex and develop color (C line).

 

COVID-19 rapid test methods

For Serum/Plasma

IgM/IgG Koronavírus gyorsteszt első lépés

1.

Remove the test device from the sealed pouch, place it on a clean and level surface with the sample well up. Add one (1) full drop of serum or plasma (10 μ) vertically into the sample

Covid-19 rapid test second step

2.

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

Coronavirus (COVID-19) IgG IgM rapid test result

3.

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

For Whole Blood

IgM/IgG Koronavírus gyorsteszt első lépés

1.

Remove the test cassette from the sealed pouch, place it on a clean and level surface with the sample well up. Add two (2) full drops of whole blood (20μ) vertically into the sample well.

Covid-19 IgM/IgG rapid test second step

2.

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

Coronavirus (COVID-19) IgG IgM rapid test result

3.

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

Interpretation of results

Coronavirus (COVID-19) IgM IgG rapid test result IgG positive

Positive

Two distinct red lines appear. One line should be in the control region (C) and another line should be in the (G) test region, indicating the lgG positive.

Coronavirus (COVID-19) IgM IgG rapid test result IgM positive

Positive

Two distinct red lines appear. One line should be in the control region (C) and another line should be in the (M) test region, indicating the lgM positive.

Coronavirus (COVID-19) IgM IgG rapid test result IgG IgM positive

Positive

Three distinct red lines appear. One line should be in the control region (C), the (G) test region and the (M) test region,  indicating the lgG and lgM positive.

Coronavirus (COVID-19) IgM IgG rapid test result IgG IgM negative

Negative

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

Coronavirus (COVID-19) IgM IgG rapid test result invalid

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.

Coronavirus (COVID-19) IgM IgG rapid test result invalid

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.

Coronavirus (COVID-19) IgM IgG rapid test result invalid

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.

Coronavirus (COVID-19) IgM IgG rapid test result invalid

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 COVID-19 rapid test

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TOTAL CONSISTENT: 94%

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).

Attentions

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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 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.

Limitations of the COVID-19 rapid test

This reagent is designed for the qualitative screening test. Concentration of SARS-CoV-2 lgM/lgG antibody cannot be determined by this qualitative 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.