The Centers for Disease Control and Prevention (CDC) announced on April 19 that it selected the Hygienic Laboratory and four other state public health laboratories to evaluate a new instrument planned for use in the CDC’s influenza real-time polymerase chain reaction (RT-PCR) clinical test. Real-time PCR is a fast and sensitive method of molecular detection of pathogens, such as influenza virus.

The Hygienic Laboratory will work with the CDC and other state public health laboratories to perform validation studies on CDC-developed real-time PCR influenza tests to obtain FDA clearance for its use as a diagnostic. The instrument previously was approved by the FDA for clinical testing, but not yet as a diagnostic.

The new instrument is an upgraded version of a PCR instrument that was used in the original test validation studies by the FDA. The Hygienic Laboratory was one of the laboratories involved with test validation, which began in 2010, and has been asked to participate in every trial since then.

The estimated value of the instrument is approximately $75,000.