Test Reference Number COLLOIDAL GOLD - 3R - REID SARS-CoV-2 Antibody Test Strip is a rapid, accurate and simple point-of-care lgG-lgM combined antibody test kit, using colloidal gold immunochromatography assay, which can qualitatively detect lgM and lgG antibodies simultaneously against SARS-CoV-2 virus in human blood within 15-20 minutes.
Brand VCare.Earth Clinical Test Results
Relative Sensitivity (%) 129/142 90.85%
Relative Specificity (%) 381/381 100.00%


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Certifications TÜV Rheinland
EN ISO 13485:2016 certified by TÜV Rheinland
Standards Applied
EN ISO 13485:2016
Medical devices - Quality management systems - Requirements for regulatory purposed
(ISO 13485:2016)
DIN EN ISO 13485:2016
General Applicable Directive Directive 98/79/EC of European Parliament and of the Council of on In Vitro Diagnostic Medical Devices (IVDD)
Annex IV excluding (4, 6) (List A and B and devices for self-testing)
Scope Of Application

COVID-19 IgG/IgM Rapid Test Cassette is for the detection of IgG/IgM in human serum, plasma or whole blood. It cannot be used as the basis for the diagnosis detection and of exclusion of COVID-19.

Intended Use

This kit is suitable for in-vitro qualitative detection of antibodies against novel coronavirus disease (COVID-19) in suspected/confirmed patients, serum/ whole blood samples. Compared with nucleic acid detection, there is much less false negative test result and the possibility of false positive test result is also very low. It can be used as a supplementary diagnostic tool for those with novel coronavirus nucleic acid test negative and suspected cases, or as a collaborative test of nucleic acid test in diagnosis of suspected cases, or as a confirmation in diagnosis and treatment.

FEATURES

Features
  • Can qualitatively detect IgM and IgG SARS-CoV-2 specific antibodies simultaneously.
  • Commercially available.
  • Easy to perform.
  • Single use, rapid test.
  • Very short time to get test result.
  • Long-term stability at room temperature.
  • Relatively inexpensive to make.
Detection Principle

The kit uses colloidal gold immunochromatography and indirect immune capture principle of comprehensive detection technology to detect IgG/IgM of Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) in human serum, plasma and whole blood. During detection, the colloidal gold labeled recombinant antigens bind to the SARS-CoV-2 antibodies in the sample to form immune complexes. The immune complexes move forward along the cassette by chromatography. The IgM in the immune complexes will be captured by the pre-coated anti-human IgM on the test zone, condense the color to form the reaction line M. The IgG in the immune complexes will be captured by pre-coated anti-human IgG on the test zone, condense the color to form the reaction line G. The colloidal gold-labeled chicken IgY antibodies are combined with the pre-coated goat anti-chicken IgY antibodies on the quality control line to form the quality control line C.

HOW TO USE

Disclaimer

VCare.Earth makes no warranties, express or implied, of marketing or use for a particular purpose of this product. It is the user's responsibility to decide on its use and/or application, for which VCare.Earth will not be responsible for the possible damages and losses derived from the use of the product, regardless of whether they are direct, indirect, special, consequential, contractual, or any other nature. The sole and exclusive responsibility of VCare.Earth, in the event that the product is defective, will be the replacement of the product or refund of the purchase price.

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