Test Reference Number COLLOIDAL GOLD - 2R - MARC 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
Serum / Plasma Sensitivity 96.3%
Specificity 99.6%
Whole Blood Sensitivity 95.0%
Specificity 99.2%


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Certifications certificate status Sinocare has passed ISO13485 system certification with CE qualification.
TÜV Rheinland
EN ISO 13485:2016 certified by TÜV Rheinland LGA Products GmbH
Standards Applied
EN ISO 13485:2016
Medical devices - Quality management systems - Requirements for regulatory purposed
(ISO 13485:2016)
DIN EN ISO 13485:2016
Certificate Registration No. SX 60139875 0001
General Applicable Directive Directive 98/79/EC of European Parliament and of the Council of 27 October 1998 on in vitro
Diagnostic Medical Devices.
CONFORMITY ASSESSMENT PROCEDURE
Annex III, according to Article 9 of Directive 98/79/EC
Scope Of Application

Application of the Novel Coronavirus (SARS-CoV-2) IgG/IgM Antibody Rapid Test

The application of our rapid test-kit is very simple: Only two drops of capillary blood from the fingertip and three drops of flux are needed. The test can be evaluated after 15-20 minutes using colloidal gold immunochromatography essay.

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 novel virus, now known as SARS-CoV-2 (also known as 2019 - nCoV), a RNA virus of the beta coronavirus family. IgG-IgM combined antibody test is suitable for rapid detection and screening of the large amount of suspected patients and asymptomatic carriers to prevent secondary transmission and assure timely treatment of infections.

Specific Performance

Product: SARS-CoV-2 Antibody Test Strip (Colloidal Gold Method)
Specimen: Whole blood / Serum / Plasma
Sample Volume: 10μL of whole blood / serum / plasma
Test Time: 15-20 minutes
Package: 25strips/box; 5 strips/box; 1 strip/box
Storage Condition: Store at 4°C - 30°C in the foil punch, keep away from direct sunlight, moisture and heat. Do not freeze.

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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