Kezdőlap 9 Product 9 COVID-19 IgM/IgG Antibody Rapid Test – Well Biotech Orawell (1 Test)

Well Biotech Orawell COVID-19 Antibody Rapid Test (1 test/kit)

IgM/IgG COVID-19 Antibody Rapid Test

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• The price includes 5% VAT.

Price: €6.72/test

Introduction

COVID-19 IgM/IgG Antibody Rapid Test for the qualitative determination of COVID-19 IgM and IgG antibodies in human whole blood (fingertip), serum or plasma. The coronavirus antibody test kit consists of test devices and buffer. It is for in vitro diagnostic use only, and can be used in point-of-care testing settings and central laboratories. For professional use.

Specification

Product name: COVID-19 IgM/IgG Antibody Rapid Test
Specimen: Whole Blood/Serum/Plasma
Kit size: 1 Test/Kit
Format: Cassette
Manufacturer: Jiangsu Well Biotech Co. Ltd.
Expiration date: 2023.08.25

Licences:
File number: OGYÉI/33045-3/2021
Registration number: HU/CA01/33045/21

Certificates

Instructions

Main components of the COVID-19 antibody test kit:

  • Test cassette
  • Sample dilution
  • Disposable plastic straw
  • Orange sterile lancet
  • Alcohol pads
  • Instructions
IgM/IgG COVID-19 Antibody Rapis Test

COVID-19 IgM/IgG rapid test procedure

Allow the test device, specimen, buffer, and/or controls to reach room temperature (15 to 30°C) prior to testing.

  1. Remove the test device from the sealed pouch and use it as soon as
    possible.
  2. Put a test device on a dust-free clean surface.
  3. Using the lancet: press the narrow end of the orange lancet firmly against the fingertip until the needle pops out automatically then squeeze the fingertip to squeeze out the blood sample.

1.

Covid-19 antibody test procedure

Apply 10μl whole blood (from vein or
fingertip), serum or plasma onto the sample well of the test device.

2.

IgM/IgG Koronavírus gyorsteszt második lépés

Apply 2 drops (about 60-80μl) of buffer onto the sample well of the test device.

3.

IgM/IgG Koronavírus gyorsteszt harmadik lépés

Read the result after 10 minutes. Do not interpret the result after 15 minutes.

Interpretation of the test results

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

Positive

 The COVID-19 IgG antibody is detected if the control line (C) and the detection (G) IgG line are both colored, and the detection line (M) IgM is not colored, that means the COVID-19 IgG antibody is positive.

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

Positive

The COVID-19 IgM antibody is detected if the control line (C) and the detection line (M) IgM are both colored, and the detection (G) IgG line is not colored, that means the COVID-19 IgM antibody is positive.

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

Positive

The COVID-19 IgG and IgM antibodies are detected if the control line (C), the detection line (G and M) IgM and IgG are both colored, which
means both the COVID-19 IgG and IgM antibodies are positive.

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

Negative

If there is only quality control line C is colored, the IgG and IgM detection lines are not colored, the COVID-19 IgM/IgG antibody is not detected, that means the result is negative.

 

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

Invalid

If the quality control line C is not colored, no matter whether the detection line IgM/IgG is colored or not, the result is invalid and needs to be tested again.

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

Invalid

If the quality control line C is not colored, no matter whether the detection line IgM/IgG is colored or not, the result is invalid and needs to be tested again.

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

Invalid

If the quality control line C is not colored, no matter whether the detection line IgM/IgG is colored or not, the result is invalid and needs to be tested again.

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

Invalid

If the quality control line C is not colored, no matter whether the detection line IgM/IgG is colored or not, the result is invalid and needs to be tested again.

Performance characteristics of the COVID-19 antibody rapid test

Positive and negative coincidence rate total: 98.67%