GLOBAL MEDICAL SURGERY EQUIPMENTS & PHARMA

GLOBAL MEDICAL SURGERY EQUIPMENT & PHARMA L.L.C.

COVID-19 IgM/IgG Plus

Intended Use

STANDARD Q COVID-19 IgM/IgG Plus Test is a rapid chromatographic immunoassay for the qualitative detection of specific antibodies(anti-SARS-CoV-2 nucleocapsid(N) protein antibodies and anti-SARS-CoV-2 Spike RBD antibodies) to SARS-CoV-2 present in human serum, plasma or whole blood.

This test is for in vitro professional diagnostic use and intended as an aid to diagnosis of SARS-CoV-2 infection in convalescent phase of patient with clinical symptoms with SARS-CoV-2 infection. It provides only an initial screening test result. More specific alternative diagnosis methods should be performed in order to obtain the confirmation of SARS-CoV-2 infection.

Advantage
  • Getting a fast result in 10 ~ 15 minutes
  • Easy handling which does not require specific training
  • Suitable for Point Of Care Testing
  • No follow-ups or equipment required
  • Video guide provided (soon)
  • External quality control available (option)
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STANDARD Q COVID-19 IgM/IgG Plus Test is a rapid chromatographic immunoassay for the qualitative presumptive detection of specific IgM and IgG to SARS-CoV-2 virus in humoral fluid.

Specifications

Specimen Whole blood, Serum, Plasma
Test time In 10 ~ 15 minutes
Specimen volume Whole blood(20μl), Serum(10μl), Plasma(10μl)
Sensitivity 99.03%(102/103)
Specificity 98.65%(219/222)
Storage temperature 2-30℃/36-86℉

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