The Calprotectin Immunoturbidimetric Assay is authorised in the US for in vitro diagnostic use to diagnose inflammatory bowel disease, specifically ulcerative colitis and Crohn's disease
The Calprotectin Immunoturbidimetric Assay is authorised for in vitro diagnostic use in the US to diagnose IBD. (Credit: Louis Reed on Unsplash)
Speciality diagnostic solutions provider American Laboratory Products (ALPCO) has commercially launched Calprotectin Immunoturbidimetric Assay to add to its portfolio of gastrointestinal (GI) diagnostic solutions.
The US Food and Drug Administration (FDA) granted the 510(k) clearance to the assay in June 2023. In the following month, the assay was unveiled during the annual meeting of the American Association for Clinical Chemistry (now ADLM).
The Calprotectin Immunoturbidimetric Assay is authorised for in vitro diagnostic use in the US to diagnose inflammatory bowel disease (IBD), specifically ulcerative colitis (UC) and Crohn’s disease (CD).
Additionally, the assay assists in distinguishing IBD from IBS when combined with other clinical and laboratory observations.
According to ALPCO, its assay demonstrated a clinical sensitivity of 90.5% and clinical specificity of 93.4%.
The minimal false-positive rate of the assay empowers clinicians to efficiently prioritise patients for confirmatory colonoscopies, thereby reducing unnecessary procedures for individuals with IBS, said the company.
The Calprotectin Immunoturbidimetric Assay, which was developed in collaboration with Diazyme Laboratories, has been designed to be compatible with the majority of clinical chemistry analysers available in the market.
ALPCO-GeneProof CEO Erik Allen said: “We’re thrilled to deliver a high-throughput test that is compatible with existing clinical chemistry analysers while preserving accurate differentiation between IBD and IBS, embodying our unwavering commitment to providing efficiency, reliability, and accuracy for our customers.”
ALPCO said that the Calprotectin Immunoturbidimetric Assay strategically enhances its range of GI solutions. Furthermore, the company said that the assay presents an attractive choice, especially for hospitals and large reference laboratories in search of dependable, streamlined, and high-throughput testing solutions.
Genova Diagnostics chief scientific officer and senior laboratory director Amy Peace Brewer said: “[ALPCO’s] new calprotectin assay is very impressive. We were able to validate and get the assay into production in a very short time frame.
“The assay hasn’t let us down and performs in a robust and reliable way. The very quick run times accommodate large batches with ease and efficiency.”