The Food and Drug Administration (FDA) has approved Grifols’ ID Core XT, a molecular-based assay designed for use in transfusion medicine, to help determine blood compatibility.
The assay identifies blood donor and patient non-ABO red blood cell types by detecting 29 polymorphisms that determine 37 non-ABO blood group antigens. It is the second molecular assay approved for use in transfusion medicine and the first to report genotypes as final results.
Grifols hopes that a molecular test will improve upon traditional serological blood typing assays, which can be limited by factors such as the availability of antisera. In particular, this test could improve blood matching for patients who receive repeated transfusions and who are more likely to develop antibodies to non-ABO antigens in addition to the main ABO blood group antigens.
As part of the FDA approval process for this test, a study was conducted to compare the typing results of the ID Core XT with licensed serological reagents, the first FDA-approved molecular blood typing assay, and DNA sequencing tests. The results demonstrated comparable performance among all the methods.
FDA Clears Abbott’s Molecular POC Tests for Flu, Strep
Abbott has received Food and Drug Administration clearance for its next-generation Influenza A & B 2 and Strep A 2 molecular point-of-care assays. The Influenza A & B 2 assay differentiates between influenza A and B virus in 13 minutes or less, with early positive results in as little as 5 minutes.
The test also allows for room temperature storage of all test components. The Strep A 2 detects nucleic acid from group A Streptococcus bacteria, the primary cause of bacterial pharyngitis, in 6 minutes or less, with positive results as early as 2 minutes. No culture confirmation is required for negative results for the Strep A 2.
Both assays have been granted a CLIA certificate of waiver and are currently available on the ID NOW (formerly Alere i) platform. The ID NOW, a CLIA-waived point-of-care molecular platform, uses Abbott’s isothermal nucleic acid amplification technology.
Ansh Labs Gets FDA Authorization for Menopausal Status Test
Through the de novo premarket review pathway, the Food and Drug Administration (FDA) has permitted marketing of Ansh Labs’ PicoAMH enzyme linked immunosorbent assay (ELISA) kit to aid in determining a patient’s menopausal status.
The test is designed for use in conjunction with other clinical assessments and laboratory findings to help inform decisions on preventive care for conditions such as osteoporosis or cardiovascular disease, for which women are at increased risk after menopause.
To determine whether a woman is approaching or is likely to have reached her final menstrual period, the PicoAMH ELISA measures the amount of anti-Müllerian hormone in her blood. Healthcare providers should carefully evaluate these results in the context of a full clinical work-up to ensure that contraceptives are not discontinued in women who have not yet reached menopause and that uterine bleeding due to endometrial cancer is not dismissed as a diagnosis, FDA noted.The PicoAMH test should also not be used to assess a woman’s fertility status or to monitor fertility treatments.
GenePOC Earns Health Canada Approval for C. Difficile Test
Health Canada has approved the GenePOC CDiff assay, a molecular diagnostic test for the qualitative detection of Clostridioides difficile (C. difficile). This test detects the toxin B (tcdB) gene of toxigenic C. difficile in unformed stool specimens obtained from patients suspected of having C. difficile infection.
The test is designed to run on the revogene instrument, a fluorescence-based real-time polymerase chain reaction platform that employs single-use microfluidic cartridges. The GenePOC CDiff allows throughput of up to eight samples in one 70-minute run. After completion of a run, the revogene system computes the results using measured fluorescent signals and embedded calculation algorithms. The resulting data can be displayed on a touchscreen, printed, or saved. The test also features embedded process control to monitor sample processing and ensure optimal quality.
CE Mark Granted to Hologic for Bordetella Test
Hologic has received the CE mark for its Panther Fusion Bordetella assay. This fully automated test uses real-time polymerase chain reaction (PCR) to detect Bordetella pertussis (B. pertussis) and Bordetella parapertussis (B. parapertussis) from nasopharyngeal swab specimens collected from symptomatic patients.
The test is intended to aid differentiation between B. pertussis, the primary cause of whooping cough, and B. parapertussis, which is responsible for a whooping-cough- like disease that is not easily distinguished from B. pertussis infection by symptoms alone.
Hologic’s test runs on the Panther Fusion platform and features ready-to-use, unit-dose lyophilized reagents, which have 60-day onboard stability. The Panther Fusion is available either as a full system or as a module that can be attached to existing Panther systems in the field. As a module, the Panther Fusion extends testing capabilities to include PCR assays in addition to tests based on transcription-mediated amplification.
China FDA Approves More Diagnostics Immunosuppressant Drug Controls
The U.S.-based company More Diagnostics has received approval from the China Food and Drug Administration for its Rap/Tac/CsA controls in a whole blood matrix. Labs can use these controls for calibration checks when performing therapeutic drug monitoring of the immunosuppressants rapamycin, tacrolimus, and cyclosporine.
The controls for each drug—available at four clinically significant concentration levels—are designed to be run side by side with a patient sample through all phases of an assay. A value sheet provided with the control set gives expected recovery ranges for many chemistry analyzers as well as liquid chromatography tandem-mass spectrometry testing. Additionally, the controls do not require reconstitution because they are in frozen form. They have a shelf life of 4 years when stored at less than -14°C and 45 days when thawed and stored at 2-8°C. Also included with this set is a control for the drug everolimus, but as an unassayed analyte.