Bio-Rad Laboratories, Inc. (Hercules, Calif.) has received FDA approval for its new Multispot HIV-1/HIV-2 Rapid Test. The highly sensitive test kit will aid in the diagnosis of HIV-1/HIV-2.
The test is the only single-use assay to be approved by the FDA for the detection and differentiation of HIV-1 and HIV-2 antibodies. The test can be used on both fresh and frozen serum and plasma samples and produces results in just 10 minutes.
The new test has been shown to provide 100% sensitivity and specificity (99.9%). The assay is also suitable for use in multitest algorithms designed for statistical validation of rapid HIV test results.