An Effective Screening Point-Of-Care Test

If an infection with SARS-CoV-2 (Corona 2019) is present or not, our rapid test detects in only 10 minutes whether a patient is infected or not. The detection of SARS-CoV-2 infection is based on the two immunoglobulins IgM and IgG in the blood of the patients.

Clinical Test Results Sensitivity 95.65%
Specificity 98.14%

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Certifications
EN ISO 13485:2016 certified by TÜV Rheinland LGA Products GmbH
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: Annex III The product meets the provisions of the European Directive 98/79/EC for in vitro Diagnostic Medical Devices.

All supporting documentations are retained at the premises of the manufacturer.

Standards Applied EN ISO 18113-1:2011
EN ISO 14971:2012
EN ISO 13485:2016
EN ISO 18113-2:2011
EN ISO 23640:2015
EN 13641:2002
EN ISO 15223-1:2016
EN ISO 17511:2000
EN 13612:2002

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 10 minutes with the matched laser pointer included in our kit.

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. The positive detection rate is more than 99%. 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.

DETECTION PRINCIPLE When the body is attacked by the COVID 19 virus, the body’s immune system activates the response mechanism, and blood cells produce antibodies. According to the structure, the immunoglobulin was divided into five types: IgM, IgA, IgG, IgD and IgE. IgM is the first immunoglobulin synthesized by fetus, which mainly exists in the blood of organism and plays an important role in preventing bacteremia. IgM antibody is the first secretion antibody in the immune response. Once infected, IgM is rapidly produced and will decrease and disappear over time.

IgG plays the role of activating complement, neutralizing toxin in immune response, IgG appears after IgM. IgM positive could be used as a diagnostic index for the early infection of novel coronavirus. However, the detection of IgM negative, can’t be an exclusion factor for novel coronavirus infection. IgG index is still needed. IgG appears late than IgM, but it exists in vivo for a long time, with higher content, longer survival time which needs dynamic observation.

The combined detection of novel coronavirus IgG and IgM antibody can be used to assist in the diagnosis of novel coronavirus infection and is helpful for the early detection of novel coronavirus pneumonia infection in the incubation period.

LESS FALSE-POSITIVE TEST RESULTS Our test uses a time-resolved fluorescence immunochromatographic method (no colloidal gold) which is the latest generation of instant detection, with greatly improved sensitivity and accuracy! Based on immunofluorescence, we have added a time-resolved patented technology which results in great improvement range of detection, accuracy (zero background interference), and sensitivity!

SPECIFIC PERFORMANCE
  1. Compliance rate of positive reference materials (RM): (1) No IgG negative reaction (10/10) was found in 10 samples of IgG positive RM; (2) No IgM negative reaction (10/10) was found in 10 samples of IgM positive RM.
  2. Compliance rate of negative RM: No IgG / IgM positive reaction (10/10) was found in 10 samples of negative RM.
  3. Lower limits of measurement: (1) No IgG negative reaction (10/10) was found using IgG Limit of Detection (LOD) RM tested 10 repeats; (2) No IgM negative reaction (10/10) was found using IgM LOD RM tested 10 repeats.
  4. Precision: Compliance rate of positive RM for IgG and IgM are all more than 95% when tested 20 repeats.