Mycoplasma Pneumoniae (MP)-IgM Antibody Rapid Test Catalog No.: BG1102C
Packing specification 20 test cards/ box
Intended Use This kit is used to qualitatively detect the existence of MP
-IgMantibodies in serum or plasma sample, as an auxiliary
diagnostic reagent of MP infection in clinic. Mycoplasma
pneumoniae(MP) is the common pathogenic microorganisms that caused
the primary atypical pneumonia and other respiratory infections
diseases. In addition to the respiratory tract that MP can cause
other serious complication. MP infection is widespread and it can
cause pharyngitis, tonsillitis, bronchitis, lung abscess, pulmonary
bullae and pleurisy and multi system damage. It is not easy to
identify the pneumonia is caused by MP, viruses, bacteria and other
pathogens infection. And the treatment of MP infection is different
to other bacterial or viral infections. MP –IgM is a specific
antibody appeared first after MP infection. It can be detected in 7
days while onset.
Test Procedure 1.Test preparation: 10μL, 100μL micropipettes and matched tips 2.Test process: The temperature of the kit and the test sample
should be the same with room temperature before test. Place the
test card on a dry horizontal work surface. Add 10μL serum or
plasma sample into the sample well, then add 100 μL of sample
dilution immediately. Observe the result in 15-20 minutes after the
serum or plasma samples added. The observation is invalid after 20
minutes.
Test results explain
To develop color on C line only: negative; To develop color on both
C line and T line: positive; To develop color on T line only:
invalid; Not to develop color on both C line and T line: invalid. Note: Re-detection if the detection result is invalid. The invalid
test cards should be dealt as infectious pollutants. The
temperature of the kit and the test sample should be the same with
room temperature before pre-detection.
Biovantion Inc is independent from international department of
Bioneovan Co., Ltd., which established in 2 0 0 5, is an in vitro
diagnostic reagents manufacturer engaged in the research,
development, production, and focus on clinical testing for
infectious diseases, such as Hepatitis virus, Noro virus, Parvo
virus test kits, our products include rapid test cassette and Elisa
kits.
All our products have been registered in National Medical Products
Administration of China, in year 2020 we get Certificate of ISO
13485:2016 – QUALITY MANAGEMENT SYSTEMS FOR MEDICAL DEVICES from
SGS. More importantly, we have awarded the registration certificate
from National Medical Products Administration for Diagnostic Kit
for IgM Antibody to COVID-19 and IgG antibody to COVID-19 during
the outbreak in China, and also we developed COVID-19 Antigen test
; Neutralizing Antibody Test, these products selling well all
overthe world
