Biomarkers

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The OnSite Troponin I Combo Rapid Test is a lateral flow chromatographic immunoassay for the qualitative detection of cardiac Troponin I (cTnI) in human serum, plasma or whole blood. The test has a detection sensitivity of 0.3 ng/mL in human serum/plasma and 0.5 ng/mL in whole blood. It can be performed within 15 minutes by minimally skilled personnel, and without the use of laboratory equipment. The OnSite Troponin I Combo Rapid Test It is intended to be used as a screening test by professionals and provides a preliminary test result to aid in the early diagnosis of Acute Myocardial Infarction (AMI). Any use or interpretation of this preliminary test result must also rely on patient’s symptoms and the professional judgment of a physician. A more precise test method such as an instrument method must be used to confirm the test result obtained by this device. AMI susceptible levels of cTnI in the blood are very low (≥0.3 ng/mL) as cTnI is released into the blood stream in forms of free cTnI and cTnI-C-T complex at 4-6 hours after myocardial cell damage. The elevated level of cTnI could be elevated as high as 50 ng/mL during 60-80 hours after AMI and remains detectable for up to 10 -14 days post AMI. Therefore, circulating cTnI is a specific and sensitive marker for AMI.

Features:

• Relative Sensitivity: 95.6% (95% CI: 91.5-97.7%) compared to a reference CLIA
• Analytical sensitivity: The detection limit of cTnI is 0.3 ng/mL in serum or plasma specimen and 0.5 ng/mL in whole blood specimen
• Cross-reactivity: no cross reactivity with 10 µg/mL skeletal muscle TnI, 10 µg/mL cardiac muscle TnT, 10 µg/mL cardiac nuscle TnC, HAMA, RH (up to 8400 IU/mL)
• Interference: No interference was seen with 60 g/L Albumin, 20 mg/dL Bilirubin, 442 µmol/L Creatinine, 3.4 µmol/L EDTA, 55 mmol/L Glucose, 3,000 U/L Heparin, 1000 mg/dL Human IgG, 2 g/L Hemoglobin, 34 mmol/L Salicylic acid, 3.8% solium citrate
• Individually sealed foil pouches containing: One cassette device, One desiccant
• Plastic droppers
• One package insert (instruction for use)

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The OnSite RF Rapid Test is a lateral flow immunoassay for the qualitative detection of all subtypes of rheumatoid factor (RF) in human serum, plasma or whole blood at a sensitivity of 8 IU/mL.

Features:

• Individually sealed foil pouches containing: One cassette device, One desiccant
• 5 µL capillary tubes
• Sample diluent (REF SB-R0310, 5 mL/bottle)
• One package insert (instruction for use)
• Simple procedure minimizes risk of operator error- no sample preparation required
• The least complicated RF test-can be performed in any setting by any health care provider with simple training
• Rapid test format allows room temperature shipping and storage

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The OnSite PSA Semi-quantitative Rapid Test is a lateral flow chromatographic immunoassay for the semi-quantitative detection of prostate specific antigen (PSA) in human whole blood, serum or plasma at a cut-off level of 4 ng/mL.

Features:

• Individually sealed foil pouches containing: One cassette device, One desiccant
• Plastic droppers
• One package insert (instruction for use)
• Non-invasive screening method for prostate cancer
• Three-line test result to facilitate determination of patient’s PSA level