Products – Page 3 – Codix Healthcare

Standard M10 MDR-TB

Standard M10 MDR-TB STANDARD M10 MDR-TB is a molecular in vitro diagnostic assay that aids in the simultaneous detection of Mycobacterium tuberculosis complex and drug-resistance against rifampicin (RIF) and isoniazid (INH) based on nucleic acid amplification technology, real-time PCR. STANDARD M10 MDR-TB is an all-in-one cartridge containing nucleic acid extraction and amplification reagents, which simplifies the testing process and allows users to obtain results within 86 minutes. Intended use STANDARD M10 MDR-TB is a multiplex real-time PCR test intended for use with STANDARD M10 system for the qualitative detection of Mycobacterium tuberculosis complex nucleic acids and drug-resistance against rifampicin (RIF) and isoniazid (INH) in human normal sputum or sputum sediment sample. Advantage All-in-one cartridge (NA extraction + amplification) Simultaneous detection of M. tuberculosis complex and drug-resistance against rifampicin (RIF) and isoniazid (INH) Fast result in 86 minutes Room temperature storage

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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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Veri Q HB Mate Analyser

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 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 CRP

STANDARD F CRP STANDARD F CRP is an immunoassay for the quantitative measurement of C-reactive protein level in human serum, plasma, and whole blood. CRP helps assess the severity and prognosis of inflammation and infection. Intended Use STANDARD F CRP is an immunoassay for the quantitative measurement of C-reactive protein level in human serum, plasma, and whole blood. The measurement of CRP provides information for the detection and evaluation of infection, tissue injury, inflammatory disorders, and associated diseases. Advantage Quantitative measurement of blood CRP levels within 3 minutes Rapid diagnosis of acute inflammatory response Enables emergency testing using whole blood Small volume fingerstick sampling (5µl) suitable for pediatric testing Specification Specimen Capillary or Venous Whole blood, Serum, Plasma Test time 3 mins Specimen volume 5 µl Measuring range 1 ~ 150 mg/L (Whole blood) | 1 ~ 130 mg/L (Serum, Plasma) Storage temperature 2 ~ 30°C / 36 ~ 86°F

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