Standard M10 MDR-TB
Standard M10 MDR-TB
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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 Q HIV/Syphilis Combo AG STANDARD Q HIV/Syphilis Combo performs qualitative analysis by detecting antibodies specific to HIV-1, HIV-2 and Syphilis (Treponema pallidum) in serum, plasma and whole blood using immuno chromatography. With a simple test method, HIV and/or syphilis infection status can be detected, and with its high sensitivity and specificity, the screening test result can be obtained within 15 minutes. FEATURES Specimen – Whole blood, Serum, Plasma Test time – 15 mins (Do not read after 20 mins) Specimen volume Whole blood: 20μl, Serum/Plasma: 10μl Effective in the detection of HIV Ab ; Sensitivity [95% CI] Specificity [95% CI] Effective in the Detection of Treponema pallidum Ab: sensitivity [95% CI], Specificity [95% CI] : Wide storage temperature range :2-40℃ / 36-104℉ No need for extra equipment.
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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 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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