Pregnancy Test Provides Additional Format

A urine dipstick test for the qualitative detection of human Chorionic Gonadotropin (hCG) has received 510(k) clearance.

The lateral flow pregnancy immunoassay has the ability to detect low hCG levels as early as 2-3 days before expected menses with a sensitivity of 25 mIU/mL. The test is very rapid giving results in three minutes.

The RapidVue hCG test is easy-to-interpret the results with a two-color endpoint that needs no special training to interpret. The kit has a long shelf life: up to 12 months from the date of manufacture, so small volume users need not worry that product will expire before used. Each test is individually foil wrapped for freshness in the 25-test kit. The manufacturers claim the test is >99% accurate.

The RapidVue hCG test is manufactured by Quidel Corporation (San Diego, CA, USA). The test has been cleared (510k) by the US Food and Drug Administration (FDA, Silver Spring, MD, USA) as a pregnancy test. The 3-minute RapidVue hCG test is Clinical Laboratory Improvement Amendments (CLIA)-waived for use with urine samples. Due to the assay's dipstick format, RapidVue hCG requires no specimen manipulation in order to perform the test.

Douglas C. Bryant, president and CEO of Quidel Corporation, said, "Our customers have expressed a preference for testing flexibility and our new RapidVue hCG product provides healthcare professionals with an additional format for pregnancy testing". RapidVue hCG is Quidel's fourth product launch in the United States this year and is further confirmation of their success at reinvigorating their new product pipeline.

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Quidel Corporation
FDA