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The Spectral West Nile virus IgM STATus™ test is a rapid immunochromatographic lateral flow assay that utilizes recombinant West Nile virus (WNV) antigen (E glycoprotein) for the qualitative detection of IgM antibodies to WNV in human serum or plasma (sodium heparin or sodium citrate). This test is for the presumptive laboratory diagnosis of West Nile virus infection in patients having signs and symptoms of meningoencephalitis. Positive results must be confirmed by the PRNT (Plaque Neutralization Reduction Test), or by using the current CDC guidelines for diagnosis of this disease. The Spectral test is not intended for point of care testing, home use or in screening blood donor samples.

A Simple and Rapid Immunoassay for the Qualitative Detection of West Nile Virus IgM Antibodies in Human Serum or Plasma. The Spectral WNV IgM STATus™ test employs solid-phase immunochromatographic assay technology to qualitatively detect the presence of WNV IgM antibodies in serum or plasma. When the specimen to be tested is dispensed into the sample well of the Spectral device, anti-WNV IgM in the sample will bind to the recombinant WNV antigen (envelop glycoprotein (E) of West Nile virus, NY99 strain) to form a tertiary complex with gold-labeled monoclonal murine antibody against flavivirus family glycoprotein E. This tertiary complex will migrate through reaction strip and be captured by goat anti-human IgM antibodies at the Test area. Excess, unreacted gold complex detector is captured by immobilized anti-mouse IgG antibodies at the Control area. A visible pinkish-purple horizontal band will appear in the Test area within 15 minutes following the addition of a sample if the level of the WNV IgM antibodies in the human serum sample is above the cut-off level. A pinkish-purple band in the Control area indicates that the test is working properly and such a band must always appear, irrespective of the WNV IgM levels, in order for the test to be valid.

For the qualitative determination of CK-MB, myoglobin, and cardiac troponin I in human whole blood, plasma or serum as an aid in the diagnosis of acute myocardial infarction in emergency room, critical care, pointof-care, and hospital settings.

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For the qualitative determination of CK-MB in human whole blood, plasma or serum as an aid in the diagnosis of acute myocardial infarction in emergency room, critical care, point-of-care, and hospital settings.

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For the qualitative determination of cardiac troponin I (cTnI) and myoglobin in numali whole blood, prasilia of the many of the of-care, and hospital settings.

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The Spectral's Troponin I test is intended for use as an in vitro diagnostic product for the rapid quantitative determination of cardiac troponin I in human whole blood, serum, and plasma. The test is used as an aid in the diagnosis of myocardial infarction in emergency room, critical care, point of care and hospital settings.

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The CardioQuant™ Troponin I Test is intended for use for as an in vitro diagnostic product to measure by immunochemical techniques the cardiac troponin I in serum and plasma. Measurement of troponin I aids in the rapid diagnosis of heart disease.

The Spectral Diagnostics CardioQuant 1 Troponin 1 Test is an automated latex immunoturbidometric method. The test utilizes monoclonal and polyclonal antibodies each covalently bound to polystyrene supercarboxylated latex particles. When serum or plasma and assay buffer are combined with the latex particles, troponin I in the specimen cross-links adjacent latex beads and produces an increase in the turbidity of the solution. The turbidity, measured at 600mm, is proportional to the concentration of troponin I present in the serum or plasma.

CardioQuant™ Cardiac Assessment Controls are intended for use as assayed quality control materials in quality assurance programs to monitor the performance of clinical diagnostic test methods for troponin I, CK-MB and myoglobin. These external controls compliment the monitoring of the test performance by the kit specific controls provided by each test device manufacturer.

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The Multiquant® Quantitative Myoglobin Test is intended for use for as an in vitro diagnostic product to measure by immunochemical techniques the myoglobin ( an oxygen storage protein found in muscle) in serum and plasma. Measurement of myoglobin aids in the rapid diagnosis of heart disease.

The Spectral Diagnostics Multiquant® Quantitative Myoglobin Test is an automated latex immunoturbidometric method. The test utilizes a monoclonal antibody and a polyclonal antibody each covalently bound to polystyrenesupercarboxylated latex particles. When serum or plasma and assay buffer are combined with the latex particles, myoglobin in the specimen crosslinks adjacent latex beads and produces an increase in the turbidity of the solution. The turbidity, measured at 600nm, is proportional to the concentration of myoglobin present in the serum or plasma.

Cardiac STATus™ Controls (CK-MB/Myoglobin/Troponin I) are intended for use as assayed quality control materials in quality assurance programs to monitor the performance of the Spectral Diagnostics Inc. Cardiac STATus™ CK-MB, Myoglobin, and Troponin I Rapid Tests. These external controls compliment the monitoring of the test performance by the internal control provided in each test device.

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