Novel Coronavirus(2019-nCoV) IgM/IgG Antibody Rapid Test
Covid-19 Test kit Features and Characteristics
CE IVD QUALITY CERTIFICATION
TÜV SÜD QUALITY CERTIFICATION
- Fast results within 15min
- Efficient detection: simultaneous monitoring of IgM and IgG
- Simple, time-saving procedure
- Whole blood/serum/plasma available
- Detection without any equipment
PRODUCT MANUAL
Novel Coronavirus (2019-nCoV) IgM/IgG Antibody Rapid Test
Package Insert
【PRODUCT NAME】
Novel Coronavirus (2019-nCoV) IgM/IgG Antibody Rapid (Colloid
Gold Method) Test
【PACKING SPECIFICATION】
25 tests/box, 50 tests/box.
【INTENDED USE】
Novel Coronavirus (2019-nCoV) IgM/IgG Antibody Rapid Test is used for detection of new coronavirus (2019-nCoV) IgM/IgG antibodies in human whole blood, serum, and plasma in vitro.
It can be used as a supplement to nucleic acid test results or in combination with nucleic acid, and cannot be used as the basis for the diagnosis and exclusion of new coronavirus (2019-nCoV) infection.
【TEST PRINCIPLE】
This kit uses immunochromatography to add the blood sample to the test card. If novel coronavirus (2019-nCoV) antibody IgM/IgG is present in the sample, it will bind to colloidal gold-labeled anti human 2019-nCoV IgM/IgG .The immune complex moves forward along the detection card under the action of capillaries. If the sample contains the novel coronavirus 2019-nCoV antibody IgM/IgG , it will bind to the novel coronavirus 2019-nCoV recombinant protein coated on the detection area on the membrane to form a purple-red stripe. The colloidal gold-labeled biotin was captured in the streptavidin-coated quality control region, forming a red stripe, showing 2019-nCoV-antibody positive.
Professional, effective, results in 15 minutes, visually discernible
After the virus invades the human body, it will be quickly recognized by the human immune system, and specific immunoglobulin antibodies will appear in human blood, and the test result will be positive.
Interpretation Of Results
- Positive result：Two red lines appear, namely the quality control line (C) and the detection line (T). Positive results are recommended for retesting. Both results are positive and further testing is recommended.
- Negative result：Only the quality control line (C) appears, and no detection line (T) appears.
- Invalid result：When the quality control line (C) does not appear, the test is invalid. It is recommended to use a new test card to repeat the test.
- Remarks: Interpretation results for 15 minutes, results for interpretation over 20 minutes are invalid
DETECTION PROCESS
1
Before blood collection, wash your hands according to the standard6-step hand washing method, and disinfect the blood collection fingers with alcohol cotton
2
Place the sterilized finger on the table and puncture the finger with the blood collection needle
3
Wipe off the first drop of blood with a cotton swab / swab, then draw 10 microliters of blood with a capillary
4
Drop 10 microliters of blood sample into the well, and bandage your fingers with a band-aid to stop bleeding
5
Add 2-3 drops of diluent and drop into the well
6
Wipe off the first drop of blood with a cotton swab / swab, then draw 10 microliters of blood with a capillary
TÜV SÜD CERTIFICATION
Bioscience Group is an important global rapid diagnostic reagent production base. The company has obtained the ISO13485 quality management system certificate
CE EU CERTIFICATION
Bioscience 2019-nCoV Antibody Diagnostic Kit has passed the European Union CE quality management system certification.
TÜV CERTIFICATION
Issued by TÜV Rheinland
CE EU CERTIFICATION
Issued by TÜV rheinland
