Standard F

Standard M10 SARS-CoV- 2

Standard M10 SARS-CoV- 2 STANDARD™ M10 is an automated point of care MDx system. STANDARD M10 is a random access and scalable solution that enables simple, fast and accurate molecular diagnostic of infectious disease, drug resistance and genetic testing from human specimens. The Standard M10 POC MDx is a versatile system that uses the Loop Mediated Isothermal Amplification (LAMP) and the Real Time Polymerase Chain Reaction (RT-PCR) process for the diagnosis of Viral Infections. The LAMP module of the Standard M10 offers an easier to operate, multiplex DNA analysis, fully enclosed system which reduces risk of sample contamination than the PCR. Yet, in keeping with the gold standard for viral evaluation, the RT-PCR option is also available on the Standard M10. The standard M10 also offers various menu assays for Tuberculosis, HIV and Hepatitis, SARS COV-2 among others. The standard M10 is CE certified and certification by the FDA EUA is currently in progress. Amongst others, the standard M10 offers the following benefits: An intuitive result interpretation Detailed summary per test Colored index indicating positive/negative/invalid. Amplification curve displayed per test. Accurate data analysis algorithm Memory up to 10,000 Fast result Isothermal amp result in 20-30 minutes RT-PCR result in 45-60 minutes Application of optimized method Qualitative assay (lamp) Qualitative assay (RT-PCR) Viral load assay (RT-PCR) Point mutation detection. Randomly accessible analyzer Minimized maintenance requirements. Intuitive status indicator Small footprint (14cm x 33cm x 32cm) Seamless connectivity 1” touchscreen Scalable configuration setting A larger number of tests are carried out per time. Multiplex assay; up to 11 targets fam/hex/cy5 One cartridge contains 4 wells and 3 fluorescent dyes for 11 targets

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Standard F HAV IgM FIA

Standard F HAV IgM FIA STANDARD F HAV IgM qualitatively analyzes hepatitis A virus IgM antibody in serum, plasma and whole blood using Fluorescent Immunoassay (FIA). With a simple test method, the test result can be obtained within 15 minutes with its high sensitivity and specificity. Intented Use This product performs qualitative analysis on hepatitis A virus IgM antibody in serum, plasma and whole blood. Easy to use, Easy to read and interpret Room temperature storage

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STANDARD F COVID-19 IgM/IgG Combo FIA

STANDARD F SARS-Cov2 nAb FIA STANDARD F SARS-CoV-2 nAb FIA is the fluorescent immunoassay for qualitative measurement of circulating neutralizing antibodies against SARS-CoV-2 in human serum and plasma. High correlation with VNT (Virus neutralization test) POCT type of neutralizing antibody test Available for testing by variant group (Group 1: Wuhan/U.K, Group 2: Brazil/South Africa/Japan) Rapid test result (35mins) Intended Use STANDARD F SARS-CoV-2 nAb FIA is a fluorescent ammunoassay for qualitative measurement of neutralizing antibodies against SARS-CoV-2 in human serum. This test is intended for use as an aid in detecting neutralizing antibodies against SARS-CoV-2 virus for purposes of clinical surveillance, post-infection screening, and post-vaccination screening.

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STANDARD F HbA1c

STANDARD F HbA1c STANDARD F HbA1c FIA performs quantitative analysis on glycosylated hemoglobin in whole blood samples using fluorescence immunochromatography. As STANDARD F Analyzer has been enhanced in its performance by using fluorescent substance, accurate quantitative test results can be obtained using with this product. Able to perform accurate quantitative analysis using fluorescent substance Hb S, Hb F, Carbamylated Hemolgobin without interference phenomenon Automatic strip recognition by reading the information stored in 2D barcode IFCC / NGSP certified Intended Use This product performs quantitative analysis on glycated hemoglobin in the whole blood samples.

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Standard F Tnl FIA

Standard F Tnl FIA STANDARD F TnI FIA performs quantitative measurement of Troponin I (TnI) level in plasma and whole blood specimens using fluorescence immunochromatography. Through the STANDARD F Analyzer, test results with high sensitivity and specificity can be obtained. TnI is a cardiac marker for the diagnosis of myocardial infarction Automatic strip recognition by reading the information stored in 2D barcode Reagents can be stored at room temperature Plasma and Whole blood specimens available Intented Use This product performs quantitative analysis on Troponin I (TnI) in plasma and whole blood

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