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.
Clinical Test Results Serum/ Plasma
Sensitivity 96.3%
Specificity 99.6%
Whole Blood Sensitivity 95.0%
Specificity 99.2%
RAPID DETECTION & SIMPLE OPERATION 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. PRODUCT SPECIFICATIONS 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.

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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.
Annex III, according to Article 9 of Directive 98/79/EC