2019-nCoV Antibody Diagnostic Reagent

2019-nCoV
PRODUCT MANUAL

EU CE QUALITY CERTIFICATION

TÜV SÜD QUALITY CERTIFICATION

Medical device production license number:Tianjin Food and Drug Supervision Equipment Production License No. 20100309

PRODUCT NAME :
2019-nCoV Antibody Diagnostic Kit (Colloidal Gold Method )

PACKING  SPECIFICATION:
2019-nCoV diagnostic kit is used for the qualitative detection of new coronavirus (2019-nCoV) antibodies in human whole blood, serum and plasma.

TEST PRINCIPLE :
This kit uses immunochromatography to add the blood sample to the test card. If 2019-nCoV-antibody is present in the sample, it will bind to colloidal gold-labeled 2019-nCoV recombinant protein.The immune complex moves forward along the detection card under the action of capillaries. If the sample contains the 2019-nCOV antibody, it will bind to the 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 purple-red stripe, showing 2019-nCoV-antibody positive.

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FOUR CORE ADVANTAGES

  • 1.Easy sampling of fingertip blood at home
  • 2.Quick results in 15 minutes
  • 3.Test results are easily discernible to the naked eye
  • 4.Widely applicable to screening of asymptomatic people and suspected patients to avoid the risk of cluster infection in hospitals

New coronavirus
The latest rapid screening technology-colloidal gold method Rapid diagnostic reagent

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 Diagnostic Technology Co.,Ltd is an important global rapid diagnostic reagent production base. The company has obtained the ISO13485 quality management system certificate issued by TÜV SÜD PRODUCT SERVICE GMBH.

CE EU CERTIFICATION

Bioscience 2019-nCoV Antibody Diagnostic Kit has passed the European Union CE quality management system certification.

Copyright 2020 all right reserved. Bioscience (Tianjin) Diagnostic Technology Co.Ltd

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