Three new automated assays for the detection of hepatitis C, human immunodeficiency virus, and hepatitis A, to run on high-throughput immunoassay system
Bayer Diagnostics has launched three new automated assays for the detection of hepatitis C (HCV), human immunodeficiency virus (HIV) and hepatitis A (HAV) to run on its high-throughput Advia Centaur immunoassay system.
The HCV assay, for the detection of IgG antibodies to the hepatitis C virus, is highly specific, minimising the risk of false positives, and can be processed automatically on the analyser without user intervention at the productive rate of 120 tests per hour.
To maximise productivity, reagents and consumables can be added to the instrument at any time without interruption to the testing process.
Demand for HCV testing is increasing in response to the introduction of clinical guidelines which are designed to control the spread of the disease and monitor the progress of treatment.
By automating the testing process, the Advia Centaur provides a high-throughput solution to the serious financial/staffing issues which inevitably result from an increased laboratory workload.
The performance of Bayer's new HCV assay has been assessed by testing 990 random donor serum samples, HCV positive patient samples and commercially available seroconversion panels.
60 specimens with potentially interfering substances, including multiple myeloma, rheumatoid factor, HAMA and other infections were also tested.
After resolution with a commercially available EIA, the sensitivity and specificity of the assay were both found to be 100%.
No false positives were observed.
This compares very favourably with third generation Elisa assays which are widely used for screening purposes, but which are known to produce a significant proportion of false positive results.
The newly launched Advia Centaur HIV1/O/2 assay is an in vitro diagnostic immunoassay for the qualitative determination of antibodies to human immunodeficiency virus (HIV) in human serum and plasma.
The presence of antibodies to HIV indicates that an individual may have been infected with HIV or may be capable of transmitting HIV infection.
The new assay detects HIV types 1 and 2 including HIV-1 group O - which is part of the worldwide healthcare standards for detecting all known types of HIV infection. "The performance of this automated assay provides greater confidence in results, minimises additional testing, thus reducing physician's doubts in diagnosis and patient's unfounded anxiety," says Alistair Gammie, Bayer Diagnostics. The addition of this assay to the Advia Centaur platform allows laboratory staff to enhance their level of automation in performing these assays with such features as software that provides automatic algorithm processing, cascade reflex testing, user-defined panels, automatic repeats of critical samples, and sample and reagent integrity checks.
Bayer Diagnostics says it is committed to the development of infectious disease assays for the Advia Centaur.
HAV IgM has also been added to the infectious disease testing menu for the instrument, complementing the toxoplasma and Rubella IgG and IgM methods, the hepatitis B (HBV) panel, HCV and HIV which are also now available.
A new HAV total assay is also in development.
The HCV and HIV 1/O/2 assays are developed, manufactured and sold by Bayer Diagnostics for Ortho-Clinical Diagnostics (Ortho), a subsidiary of Johnson and Johnson.
Under the terms of the agreement, Bayer will not represent the products for blood or plasma screening.
The complete range of infectious disease serology methods for the Advia Centaur also complements Bayer's portfolio of nucleic acid assays which are used for quantitative and qualitative viral load measurements and the detection of drug resistant viruses. Availability of these assays enables Bayer to satisfy all the clinical laboratory's needs for hepatitis/HIV diagnostic and management testing.
