FDA Grants New Clearances to Two Tests for Sexually Transmitted Infections

The Food and Drug Administration has cleared the BD Max CT/GC/TV assay, BD’s new test for Chlamydia trachomatis (CT), Neisseria gonorrhoeae (GC), and Trichomonas vaginalis (TV), and has also expanded the clearance for Cepheid’s Xpert TV so that labs can use it to test men for TV as well as women. The BD Max CT/GC/TV assay enables healthcare providers to detect these three sexually transmitted infections from a single specimen in one test. Specimens that the test uses include male or female urine, self-collected vaginal swabs, and clinician-collected endocervical swabs. Once samples are loaded onto the BD Max system, results are delivered in less than 3 hours. All reagents are ready-to-use and can be stored at room temperature.

Cepheid’s Xpert TV assay was initially cleared in October 2015 for three types of female specimens. The latest clearance extends the range of specimens and makes the Xpert TV the only cleared nucleic acid amplification test for TV that uses urine samples from symptomatic and asymptomatic men.

The Latest Round of Zika Test Authorizations in the U.S., Korea

The Food and Drug Administration has granted emergency use authorizations (EUA) to Roche and Vela Diagnostics for their Zika assays, while also expanding the EUA granted to Hologic’s Zika test to include urine samples. All three tests diagnose Zika infection by qualitatively detecting the virus’s RNA. Manufactured by TIB Molbiol and exclusively distributed by Roche, the LightMix Zika rRT-PCR test uses plasma or serum samples and runs on Roche’s LightCycler 480 Instrument II or cobas z 480 analyzer. It works in combination with a full process RNA control that monitors all testing steps from extraction to PCR result.

Vela’s Sentosa SA Zikv RT-PCR test, which recently received the CE mark as well, is authorized for use with serum, plasma, and urine collected alongside a patient-matched serum or plasma specimen. It can process 22 samples per run with a turnaround time of approximately 3 hours. Hologic’s Zika virus assay was granted an EUA for use with serum and plasma samples in June 2016. Its new use with urine samples lengthens the time period during which patients can be tested for Zika from 7 days to 14 days following symptoms, as recommended by the U.S. Centers for Disease Control and Prevention (CDC).

Korea has also authorized the use of two new Zika tests. The Korea Ministry of Food and Drug Safety has approved Bioneer’s AccuPower ZIKV (DENV, CHIKV) Multiplex real-time RT-PCR Zika virus detection kit, which simultaneously and rapidly tests for Zika, dengue, and chikungunya. Additionally, the Korea CDC has granted an EUA to Altona Diagnostics’ RealStar Zika Virus RT-PCR kit 1.0, which qualitatively detects Zika RNA in serum or urine.

Mindray Gets FDA Nod for Hematology Analyzer

Mindray has received 510(k) clearance from the Food and Drug Administration for the new Mindray BC-5390 Auto hematology analyzer. Mindray designed the BC-5390 analyzer to meet the testing needs of mid-volume laboratories while offering features commonly found on large-volume analyzers. The analyzer provides from a venous or capillary blood sample a complete blood count with 21 parameters and a 5-part differential, as well as hemoglobin analysis performed using cyanide-free reagents. It also has a built-in autoloader with 40- sample capacity, processes up to 60 samples per hour, and stores up to 100,000 results with histograms.