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

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.

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Instructions For Use

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Important Note

IMPORTANT NOTE

For Healthcare Professionals Only

For In Vitro Diagnostics or Research Use Only

View Instructions for Use here.

Patented Technology

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!

Due to the very high specificity (99%) of IgG our rapid-test offers, it can be determined whether a patient has already had a CORONA (COVID-19) infection and is now immune. This is very important to find out which population groups can resume their daily work.

Please contact us for orders here.

Overview

OVERVIEW

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.

For more details check out our FAQs page

Application

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

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

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

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

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.

Storage Instructions

STORAGE INSTRUCTIONS

All reagents are ready to use as supplied. Unopened reagent kits are stable at 4°C ~30°C for 6 months. The performance of the kit remains the same with extended transportation under 37 °C up to 14 days. It should be used within 1 hour once the pouch is opened. Do not freeze the kit or expose the kit above 37°C during storage.

Limitations

LIMITATIONS

  • For diagnostic purposes, the results should always be assessed in conjunction with the patient’s medical history, clinical examination and other findings. If there is any abnormal result when the assay procedure is correct, alternative methods (such as RT-PCR) are recommended for further confirmation.
  • Possible causes of false positive results: the patient sample may contain similar antibody components or similar antigenic epitopes, causing non-specific reactions, leading to abnormal results.
  • Possible causes of false negative results: the unknown components in the patient’s sample may prevent the effective binding of target proteins and their antibodies, and the instability of SARS-CoV-2 with time and temperature will lead to abnormal results.
  • Some drugs, rheumatoid factors, caffeine-like structures, or nonspecific substances may cause abnormal results.
  • Other factors may also cause errors in test results, such as improper operation, improper storage conditions of reagents, and other sample factors.

Certifications

CERTIFICATIONS

Certifications
CE
EN ISO 13485:2016 certified by TÜV Rheinland LGA Products GmbH
Certificate Registration No.: SX 60139875 0001
CFDA (awaiting final approval)

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

Manufacturer

MANUFACTURER

Lumigenex (Suzhou) Co., Ltd.
Building C24, 218 Xing Hu Street, SIP, Suzhou, P.R. China 215123
Tel.: +86 (512) 80988088 Fax: +86 (512) 80988096

Exclusive Distributor

EXCLUSIVE DISTRIBUTOR

Dotcom Ventures FZE
DIP 1, Showroom 10,
Dubai, PO Box 3219,
United Arab Emirates
http://www.dotcomv.com

European Representative

EUROPEAN REPRESENTATIVE

Wellkang Ltd.
Suite B, 29 Harley St.,
London, W1G 9QR, U.K.
http://www.wellkang.com/

Downloads

DOWNLOADS

VCARE COVID-19 RAPID TEST _ BUSINESS LICENCE _ MEDICAL DEVICE PRODUCTION _ FOREIGN TRADE _ EXIT INSPECTION _ CNAS CERTIFICATION

VCARE COVID-19 RAPID TEST _ CE DECLARATION OF CONFORMITY

VCARE COVID-19 RAPID TEST _ CLINICAL EVALUATION _ PACKAGE SIZE INTL SHIPPING

VCARE COVID-19 RAPID TEST _ CUSTOMS DECLARATION ENTITY

VCARE COVID-19 RAPID TEST MHRA UK

VCARE COVID-19 RAPID TEST _ TUV CERTIFICATE _ DAkkS

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.

Flyer

Instructions For Use

FAQs Contact Us

Disclaimer:

The product picture shown is for illustration purpose only. Actual product and labeling colors may vary due to product enhancements and design changes. Certifications and Class Standard always as per our documentation.