Biohit SARS-CoV-2 antibody test kit cleared by FDA

LabPulse.com staff writers
Jun 23, 2020
2020 06 17 20 35 0417 Covid 19 Antibody 400

Biohit Healthcare has received U.S. Food and Drug Administration (FDA) emergency use authorization for its SARS-CoV-2 immunoglobulin M (IgM)/immunoglobulin G (IgG) antibody test kit.

In a study conducted by researchers at Yale University, the test kit produced 100% sensitivity and 97.6% specificity for IgM, as well as 100% sensitivity and specificity for IgG, according to the company. Biohit said that more than six million of these test kits are in the pipeline and will be ready for delivery within a few days.

Latest in Validation
Breast Cancer2 Social
Reveal Genomics presents trial results for HER2Dx breast cancer test at SABCS
December 6, 2022
Breast Cancer Social
Prelude Dx to present clinical utility data for DCIS risk assessment test
October 21, 2022
Lung Cancer2 Social
Biofidelity developing assay for single-molecule detection of multiple gene fusions
October 18, 2022
Heart Social
Daxor highlights study on test in heart failure management
October 3, 2022
Related Stories
2020 04 04 00 34 1763 Lab Test Antibody 400
Immunoassays
Virality COVID-19 rapid antibody test gets emergency clearance
2020 06 22 16 05 8617 Alert Safety Risk 400
Emergency Use Authorization
FDA tells labs to remove faulty coronavirus antibody tests from stock
2019 02 13 19 24 5396 Fda Logo V2 400
Research and Development
Real-world data project will help FDA assess COVID-19 diagnostics
2020 05 01 20 07 6840 Warning Circular 400
Pathology, histology
FDA issues warnings for misbranded COVID-19 antibody tests
More in Validation
Reveal Genomics presents trial results for HER2Dx breast cancer test at SABCS
The results show that an HER2Dx risk score was significantly associated with relapse-free interval and long-term survival outcomes; additionally, HER2Dx can identify patients who might be candidates for neoadjuvants or de-escalation of systemic therapy.
December 6, 2022
Breast Cancer2 Social
Prelude Dx to present clinical utility data for DCIS risk assessment test
DCISionRT predicts radiation therapy benefit through a risk assessment test for patients with ductal carcinoma in situ (DCIS).
October 21, 2022
Breast Cancer Social
Biofidelity developing assay for single-molecule detection of multiple gene fusions
The firm said its assay analyzes DNA and RNA concurrently from a single patient sample and can return results within two days.
October 18, 2022
Lung Cancer2 Social
Daxor highlights study on test in heart failure management
Daxor highlighted results of a study from Duke Heart validating the utility of the firm's diagnostic blood test in optimizing the therapeutic management of heart failure patients.
October 3, 2022
Heart Social
Reading blood-oxygen saturation levels on a smartphone
In the study, University of Washington and University of California San Diego researchers demonstrated that the use of a smartphone camera and flash could enable detection of blood oxygen saturation levels comparable to those measured in a clinic using a pulse oximeter clipped to a finger.
September 20, 2022
2022 09 21 18 19 8909 Smartphone Oximeter 400
Ibex announces study results for breast pathology platform
Ibex chief medical officer Dr. Judith Sandbank reported at the congress 100% sensitivity and specificity for pathologists diagnosing breast cancer using the platform.
September 8, 2022
2021 02 24 22 29 5379 Breast Cancer 20210224225528 20220322220342
Most Popular
Genetic causes identified for three rare diseases
Researchers in study validate test to identify newborns with homocystinuria, a rare inherited disease
FDA reissues EUA for Janssen COVID-19 vaccine, includes warning about risks of myocarditis, pericarditis
Duke University researchers discover biomarkers may identify early pancreatic cancer risk
Netherlands researchers combine CRISPR, bioluminescence in proof-of-concept infectious disease test
Werfen completes $2B acquisition of Immucor, expands presence in specialized diagnostics
More in Validation
Week in Review: At-home flu testing, asymptomatic monkeypox, telediagnostic accuracy, and more
Dear LabPulse.com member,
September 7, 2022
Freenome launches study of multiomics cancer platform
The Sanderson Study will generate evidence of clinical validation for certain high- and elevated-risk populations while refining the platform's cancer classification and risk prediction models, the South San Francisco-based firm said.
September 5, 2022
2022 08 08 21 26 6857 Lung Cancer2 400
Interpace announces validation data for thyroid cancer test
The company said the most recent data shows that the addition of microRNA pairwise expression profiling on its ThyraMIRv2 assay provides clinically and statistically superior risk stratification of indeterminate thyroid nodules by the original ThyraMIR assay.
September 1, 2022
2017 01 30 16 54 10 442 Thyroid 400
Researchers develop same-day fetal chromosome test
In the New England Journal of Medicine on Thursday, the investigators described a rapid nanopore sequencing-based screen for aneuploidy in reproductive care, saying they have developed and validated a new short-read-based approach for library preparation, sequencing, and data analysis.
August 17, 2022
2021 06 03 21 41 0848 Patient Woman Pregnant 400
Viome launches early detection test for oral and throat cancers
The test leverages mRNA technology and an artificial intelligence platform to detect biomarkers for oral and throat cancer with 95% specificity and 90% sensitivity rates, the firm said.
August 3, 2022
2017 09 14 23 05 1167 Cancer Cell 400
North American Diagnostics recalls COVID-19 rapid tests
"North American Diagnostics did not provide the FDA with adequate validation data to show that the test's performance is accurate," the FDA wrote in the recall announcement. "This means there is a risk of potential false negative, false positive, or misinterpretation of results."
July 31, 2022
2020 05 01 20 07 6840 Warning Circular 400
Page 1 of 8
Next Page