COVID-19 /SARS-CoV-2 IgG/IgM Rapid Test 

INTENDED USE

The SARS-CoV-2 IgG/IgM Rapid Test  (Whole Blood/Serum/Plasma) is a lateral flow immunoassay for the qualitative detection and differentiation of IgG and IgM of Novel Coronavirus (SARS-CoV-2) in human wholeblood,serum or plasma. 

This test is intended to be used as an aid in the diagnosis of infection with Novel Coronavirus. Any reactive specimen with the SARS-CoV-2 IgG/IgM Rapid Test  must be confirmed with alternative testing method(s).

MATERIALS 

Test devices	Droppers
Buffer	Package insert

ASSAY PROCEDURE

• Bring the specimen and test components to room temperature if refrigerated or frozen. Place the test device on a clean, flat surface and label specimen number.
• Fill the pipette dropper with the specimen. Holding the dropper vertically, dispense 1 drop  (about 10 µL) of whole blood,serum, plasma into the sample well,making sure that there are no air bubbles.  Then add 1-2 drops (about 70-100 µL) of Sample Diluent immediately.
• Set up timer. Results can be read in 15 minutes. Don’t read result after 15 minutes.  

PERFORMANCE CHARACTERISTICS

1. Positive Coincidence Rate: The test results of positive quality control are all positive.

2. Negative Coincidence Rate: The test results of negative quality control are all negative.

3. Analytical Specificity: The test results of specimen from non- infected by novel coronavirus should be negative.

4. Analytical Sensitivity: The detection result is positive when detection of a novel coronavirus IgG strongly positive serum 1:50 dilution sensitivity reference: The detection result is positive when detection of a novel coronavirus IgM strongly positive serum 1:50 dilution sensitivity reference.

5. Intra-Assay: There is no different test results of the same quality control in the same batch.

6. Inter-Assay: There is no different test results of the same quality control from different batch.

 

Zhuhai Encode Medical Engineering Co.,Ltd (herinafter referred to as Encode) was established in 1994, as one of the earliest
and largest manufacturers of in-vitro diagnostic field in China. Encode specializes in R&D, production and distribution of in-vitro diagnostic products. As a hi-tech and innovative enterprise, we have researched and developed series of microbiological diagnostic productds and immunology diagnostic rapid tests, which are used for diagnosis of infection disease, cardiac markers, tumor markers, fertility test, durgs of abuse and sexual transmitted disease.

Encode occupies a land of 15,000 m2 in Zhuhai. There are 2,000 GMP standard clean workshops of microbiology diagnostic products, colloidal gold diagnostic products and molecular with automatic manufacturing lines and passed the quality management system evaluation by SFDA and GDFDA.

Encode has established extensive cooperation with research centers in universtities, such as Lanzhou University, South China University of Technology, Jinan University and Shanghai Plumonary Hospital, etc. Whith strong R&D and technological innovation capability. Encode ranks leading level in terms of IVD industries field in China. We have also obtained ISO 13485:2003, ISO 9001:2001, CE and have been granted the title of national hi-tech enterprise.

Today, we provide medical products and health care solution to clients not only in China, but also worldwide, such as Europe, Africa, Middle East, South East, Asia etc.

With the experience and dedication of the scientific staffs, Zhuhai Encode Medical Engineering Co.,Ltd will continue our endeavor to provide professional in-vitro diagnostic products and health care solutions to the worldwide and make our contributions to the career of human health.