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Coronavirus IgM/IgG antibody rapid test kit (25 pcs/kit) Hightop Biotech

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

Our product is in stock.

• The price includes 5% VAT.

• For professional use.

Price: 51,17/box

Unit price: 2,05/pcs

In stock (can be backordered)

In stock (can be backordered)

IgM/IgG antibody 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.

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.
Expiration date: 2023.11.24.

Certificates:
File number: OGYÉI/23612-3/2021
Registration number: HU/CA01/23612/21

Certificates

Instructions

Main components of the Covid-19 antibody test kit

  • 25 test cassettes
  • 25 sample dilutions
  • 25 disposable plastic straws
  • 25 sterile yellow lancets
  • 25 alcohol pads
  • Instructions
Hightop Biotech SARS-CoV-2 IgM/IgG Antibody Rapid Test

IgM/IgG test principle

The Hightop Biotech Covid-19 IgM/IgG antibody 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/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 M line to form a complex and develop color (M 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 M 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 G line to form a complex and develop color (G 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 G 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 antibody rapid test methods

For whole blood:

1.

IgM/IgG Koronavírus gyorsteszt első lépés

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.

2.

IgM/IgG Koronavírus gyorsteszt második lépés

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

3.

IgM/IgG Koronavírus gyorsteszt harmadik lépés

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

For serum or plasma:

1.

IgM/IgG Koronavírus gyorsteszt első lépés

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

2.

IgM/IgG Koronavírus gyorsteszt második lépés

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

3.

IgM/IgG Koronavírus gyorsteszt harmadik lépés

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

Lancet instructions

Ujjbegyszúró használata

1.

Carefully pull off the protective cap.

2.

Push the safety lancet firmly onto the chosen site to fire.

3.

Throw it in a suitable container after use. 

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 antibody rapid test

IgM IgG antibody rapid test sensitivity and specificity

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

• For IN VITRO diagnostic use only.

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

• 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.

• All 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 IgM/IgG antibody 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.