Hunan Runkun Pharmaceutical Co., Ltd.  

Product Name: Igg/Igm Rapid Test Kit Model NO.: IgM / IgG Certification: CE, FDA, ISO13485 Material: Plastic Application: Clinical Trademark: RUNKUN Transport Package: Carton Origin: China Product Description Performance Characteristics1. 59 confirmed case specimens were tested by IgM/IgG Test Kit(Colloidal Gold),55 were positive and the sensitivity was 93.22%(95% CI:82.73%~97.81% ). 147 negative specimens were detected by IgM/IgG Test Kit(Colloidal Gold), 145 were negative and the specificity was 98.64%(95% CI: 94.67%~99.76%).2. Specimens which tested positive with parainfluenza virus antibody,influenza A antibody,influenza B antibody,hepatitis B surface antigen,hepatitis C virus antibody,treponema pallidum antibody,HIV antibody,EB virus antibody from patients were investigated with by IgM/IgG Test Kit(Colloidal Gold), the results showed no cross reactivity.3. The specimens with hemoglobin, triglyceride and bilirubin will interfere the test results, and the maximum allowable concentrations are 5mg/ml, 10mg/ml and 0.2mg/ml respectively.