Abbott has received clearance from the Food and Drug Administration for a blood test that detects traumatic brain injury (TBI). According to the company, this is the first laboratory test that is commercially available in the U.S. for this indication.
The Alinity i TBI test, which delivers results in 18 minutes, measures ubiquitin C-terminal hydrolase L1 (UCH-L1) and glial fibrillary acidic protein (GFAP). In elevated serum concentrations, UCHL-1 and GFAP are tightly correlated with brain injury.
The test is approved for use in patients 18 years of age or older who present with suspected mild TBI (Glasgow Coma Scale score of 13−15) within 12 hours of injury to assist in determining whether a computed tomography (CT) scan of the head is needed.
Alinity i TBI has 96.7% sensitivity and 99.4% negative predictive value and runs on Abbott's high throughput Alinity i laboratory instrument. The test previously received European Union clearance and has been available in markets outside the U.S. since 2021.
The test could help reduce the number of unnecessary CT scans by up to 40%, potentially reducing costs to the healthcare system and patients, and minimizing time spent in the emergency department, Abbott said.
FDA OKS POINT-OF-CARE INSTRUMENT FOR FENTANYL
The Food and Drug Administration has granted Bioeasy USA, a subsidiary of Shenzhen Superbio Technology (Superbio), clearance for a point-of-care immunofluorescence analyzer to qualitatively detect fentanyl in human urine.
Bioeasy USA has partnered with Carolina Liquid Chemistries (CLC) to distribute the product in the U.S. under the brand name RYAN. CLC has a fentanyl urine detection kit that is intended for use with RYAN and that detects fentanyl in urine at a cutoff concentration of 1.0 ng/mL.
This test provides a preliminary result, which means that results must be confirmed with a more specific, alternative chemical method.
INFECTIOUS VAGINITIS TEST GETS FDA CLEARANCE
BD recently announced it has received Food and Drug Administration 510(k) clearance for the BD Vaginal panel to be used on the BD Cor System.
Originally granted marketing authorization for use on the BD Max system in 2016, the BD Vaginal panel is the first microbiome-based PCR assay that uses a single swab and test to simultaneously detect organisms associated with bacterial vaginosis (BV), vulvovaginal candidiasis (VVC), and Trichomonas vaginalis (TV) and report a clear positive or negative result for each condition separately.
This 510(k) clearance for the BD Vaginal panel on the BD Cor System is the first for the high-throughput version of the test.
Using a single test for BV, VVC, and TV could reduce the need for repeat testing and unnecessary treatments, the company said.
FDA GRANTS EUA TO QUEST COVID-19 KIT
The Food and Drug Administration recently granted emergency use authorization to Quest Diagnostics for the Quest Covid-19 Nucleic Acid test collection kit.
This kit is designed for the self-collection of anterior nasal swab specimens for use with tests that detect SARS-CoV-2 nucleic acid.
Included in the kit are specimen collection and storage materials, as well as instructions for returning the kit to a drop-off location.
CUE HEALTH RECEIVES FDA EUA FOR MONKEYPOX TEST
Cue Health has received emergency use authorization from the Food and Drug Administration for a molecular test to detect the monkeypox virus.
This nucleic acid amplification test runs on a Cue Reader and can be performed at any CLIA-waived facility. It delivers results in 25 minutes and is intended to expand patient access to fast,
The test requires a Cue Sample Wand for collecting lesion samples or dipping into viral transport medium containing a specimen. The Cue Sample Wand is then inserted into the Cue Cartridge, which is placed inside the Cue Reader, and results are delivered to a mobile device.
The test demonstrated high accuracy in trials, achieving 100% concordance with the monkeypox test from the Centers for Disease Control and Prevention on the clinical samples tested, according to Cue.
FDA GRANTS 510(K) CLEARANCE TO DIASORIN FLU AND COVID-19 TEST
DiaSorin recently announced that it has received 510(k) clearance from the Food and Drug Administration (FDA) for its Simplexa COVID-19 & Flu A/B Direct assay.
The test detects and differentiates among influenza A, influenza B, and SARS-CoV-2 viruses so physicians can recommend appropriate treatment for each patient.
The assay offers clinical laboratories a sample-to-answer diagnostic workflow that generates actionable results with minimal hands-on time.
The real-time reverse transcription-PCR assay is performed using nasopharyngeal swab samples. Designed for use on the Liaison MDx instrument, it detects viruses in a little over an hour.
The assay requires no separate sample extraction or processing. It can test up to eight samples simultaneously. This test adds to the company’s FDA-cleared menu of molecular assays used to diagnose COVID-19 and common respiratory infections.
Company officials said they hope the test will help ease the burden on clinical labs by eliminating the need to run multiple tests for each patient to reach a diagnosis.
SEXUAL HEALTH TEST FOR WOMEN GETS FDA NOD
The Food and Drug Administration has granted Visby Medical 510(k) clearance and a CLIA waiver for its second point-of-care assay, Visby Medical Sexual Health test.
The PCR test detects sexually transmitted infections caused by Chlamydia trachomatis, Neisseria gonorrhoeae, and Trichomonas vaginalis in women. It gives results in under 30 minutes, enabling clinicians to test and treat in a single patient visit.
The test provides results with about 97% accuracy, according to Visby. Company officials noted that testing for sexually transmitted infections often has a turnaround time of 2 to 5 days. They added that the Centers for Disease Control and Prevention recently reported a nearly 30% increase in gonorrhea and chlamydia between 2015 and 2019.