Products

STANDARD F Covid-19 IgM/IgG Combo FIA STANDARD F COVID-19 IgM/IgG Combo FIA is the fluorescent immunoassay for the qualitative detection of specific antibodies to SARS-CoV-2 present in human serum and whole blood. STANDARD F COVID-19 IgM/IgG Combo FIA should be used with the STANDARD F Analyzers manufactured by SD BIOSENSOR. This test is for in vitro professional diagnostic use and intended as an aid to the diagnosis of SARS-CoV-2 infection in the convalescent phase of a patient with clinical symptoms of SARS-CoV-2 infection. Advantage Total Antibody test (IgM and IgG) Superior sensitivity & specificity Suitable method for population antibody screening Specification Specimen Whole blood/Serum Test time 15 minutes Specimen volume 10 ul Sensitivity 97.74% (130/133) Sensitivity (≥7 days after symptom onset) 100% (119/119) Specificity 95.33% (143/150) Storage temperature 2-30℃ / 36-86℉

Standard F H.Pylori FIA STANDARD F H. pylori Ag FIA provides a significantly fast, easy, and accurate system to detect the H. pylori antigens in the human faecal specimen. Intended Use STANDARD F H. pylori Ag FIA is a qualitative immunoassay to detect H. pylori Ag in the human faecal specimen. The test is for in vitro diagnostic use and is intended as an aid to early diagnosis of H. pylori Ag infection. This is intended for professional use, only for an initial screening test. Advantage High correlation with CLIA product Ready to use reagents Room temperature storage Specification Specimen Faeces Test time 10 minutes Specimen volume 40 – 70mg Sensitivity 100% (5/5) Specificity 100% (150/150) Storage temperature 2-30℃ / 36-86℉

Standard F HbsAg FIA STANDARD F HBsAg FIA is a fluorescent immunoassay for the qualitative detection of Hepatitis B surface antigen (HBsAg) present in whole blood, serum and plasma. This test is for in vitro professional diagnostic use intended for asymptomatic and symptomatic individuals for diagnostic purposes of HBV infection. Intended Use STANDARD F HBsAg FIA is a fluorescent immunoassay for the qualitative detection of Hepatitis B surface antigen (HBsAg) present in whole blood, serum and plasma. Advantage Ready to use reagents Room temperature storage Fast results within 20 minutes

Standard F HCV Ab FIA STANDARD F HCV Ab FIA According to WHO, about 130-150 million people globally have chronic HCV infection, with more than 350,000 people dying from Hepatitis C-related liver diseases each year. STANDARD F HCV Ab FIA is the fluorescent immunoassay for the detection of Hepatitis C virus (HCV) antibodies in human whole blood, serum, and plasma samples. Intended Use This product performs qualitative analysis on hepatitis C virus-specific antibodies in serum, plasma and whole blood. Advantage Easy to use, Easy to read and interpret Room temperature storage

STANDARD F β-hCG FIA STANDARD F β-hCG FIA is a fluorescent immunoassay for the quantitative measurement of β-hCG level in human serum and whole blood. This test is performed to help diagnose pregnancy if a woman is to undergo a medical treatment, be placed on certain drugs, or have other testing, such as X-rays, that might harm the developing baby. Intended Use STANDARD F β-hCG FIA is a fluorescence immunoassay for the quantitative determination of total β-hCG levels in human serum and whole blood using STANDARD F Analyzers manufactured by SD BIOSENSOR. This test is an in vitro diagnostic test and is intended for use as an aid in the early detection of pregnancy. Advantage β-hCG is a hormone that can diagnose early pregnancy Automatic strip recognition by reading the information stored in a 2D barcode Reagents can be stored at room temperature Serum and Whole blood samples available Specification Specimen Whole blood, Serum Test time 10 mins (Serum), 15 mins (Whole blood) Specimen volume 50 µl Measuring range 5 – 1,500 mIU/mL Storage temperature 2 ~ 30°C / 36 ~ 86°F