News : clinical

PreAnalytiX saliva collector
QIAGEN N.V. has announced the commercialization of the new PreAnalytiX PAXgene Saliva Collector, a non-invasive and painless sample collection method that can preserve SARS-CoV-2-derived RNA copy numbers and stabilize it for 4 days at 20°C. more...
Recombinant Antigens for SARS-CoV-2 variants
Creative Diagnostics' collection of SARS-CoV-2 recombinant antigens covers mutations in Spike proteins and Nucleocapsid proteins. The reagents can be used to evaluate the efficacy of antibodies and vaccination. more...
Truenat PCR test for Nipah virus screening
Molbio Diagnostics has received EUA from India's drugs controller for its rapid qPCR Nipah virus test, co-developed with India's medical research council (ICMR). The ICMR has recently set up a Nipah virus screening lab near to where a fatal case of infection was reported.  more...
SARS-CoV-2 Immunity testing
EUROIMMUN offers a powerful trio of tests for analysis of SARS-CoV-2 immune responses, encompassing quantitative measurement of anti-S1/RBD antibodies, detection of neutralising antibodies targeting S1/RBD, and analysis of SARS-CoV-2-reactive T cells. more...
Recombinant SARS-CoV-2 antigens for vaccine research
Sino Biological has developed 200+ recombinant SARS-CoV-2 variants, covering Lambda, Delta, and more Variants of Concern (VOCs) and Variants of Interest (VOIs), which can be used to evaluate the efficacy of the antibodies and vaccination. more...
Rapid COVID-19 Test Given Approval in Indonesia
Achiko's AptameX™ test for COVID-19 diagnosis has been granted approval by the Indonesian Ministry of Health. The test is API compatible, and manufacturers say they are now seeking CE-marking. more...
Seegene self-collection swab
Seegene has obtained CE-marking for its self-collection patient-friendly swab used as the sampling device for 4 of its SARS-CoV-2 diagnostic assays. more...
Roche has acquired the TIB Molbiol Group and its portfolio of over 45 CE-IVD assays which include its tests to identify SARS-CoV-2 variants.  more...
Neutralizing antibodies for COVID-19 vaccine potency and immunity studies
Fapon Biotech's COVID-19 neutralizing antibodies (NAbs) can be used in array of assays used to determine vaccine potency and antibody detection. These reagents have demonstrated high affinity, sensitivity and specificity in several verification studies.  more...
The ECDC has released a technical report on the need for COVID-19 vaccine boosters shots and have concluded there is no urgent need for the general population.  more...
Rapid Antigen Test for SARS-CoV-2
The Department of Health and Social Care (UK) has laid down new rules for SARS-CoV-2 lateral-flow antigen tests. Manufacturers must now substantiate accuracy claims with clinical performance data, and tests should be allowed to be performed by non-professionals. more...
SARS-CoV-2 Whole Virus Antigen Controls for Point-of-Care Diagnostics
Microbiologics has launched a new SARS-CoV-2 quality control (QC) product designed for use with antigen POC methods. It serves as a non-viable, external, positive control to evaluate the assay’s performance and mitigate the potential for false-negative or false-positive results. more...
The CMA has sent an open letter to PCR COVID-19 test providers warning that a range of harmful practices in the sector could breach consumer protection law. more...
BD Veritor
The US FDA has granted the BD Veritor™ At-Home COVID-19 Test EUA. The antigen test is used in conjunction with the Scanwell Health smartphone app that can read and interpret the image taken by the phone's camera and return a result in 15 minutes. more...
Sino Biological on Stock Exchange
Sino Biological has announced a successful listing on the Shenzhen Stock Exchange subsidiary ChiNext under the stock abbreviation Sino Biological and stock code 301047. A total of 17 million shares were issued for a total of 4.98 billion RMB raised during this initial public offering.  more...
A new perspective on the origins of SARS-CoV-2 has been published in Science (AAAS) links an increase in the wild animal trade post-African Swine Fever pandemic to an increased risk of virus-susceptible animals exposed to humans. more...
BD Veritor System for Rapid Detection of SARS-CoV-2 and Flu A and B assay
BD is now taking orders for its FDA-EUA Veritor™ System for Rapid Detection of SARS-CoV-2 & Flu A+B assay. It takes about 15 minutes to run on the BD Veritor™ Plus System and distinguishes between SARS-CoV-2, influenza A and influenza B more...
Qorvo omnia rapid antigen test
An FDA-EUA SARS-CoV-2 rapid antigen test using bulk-acoustic wave sensor technology has demonstrated its low LoD in an independent study, partly funded by NIH. more...
Cepheid Xpert HIV-1 Load XC
Cepheid has announced that it has received CE-IVD clearance for Xpert® HIV-1 Viral Load XC and Xpert® HIV-1 Qual XC, next-generation extended-coverage (XC) tests for HIV testing. more...
Fapon Biotech Completed COVID-19 One-Stop Shop Solutions
With the COVID-19 pandemic still spreading globally and even constantly evolving over the past years, Fapon Biotech has mobilized resources to launch Completed COVID-19 One-Stop Solutions that enables virus detection, immune system evaluation of vaccines, and variant tracking. more...
Antibodies for Influenza Antigen Test
Sino Biological has identified six Pan antibody pairs with high sensitivity (pg level) against the NP protein of Influenza A and Influenza B. They also demonstrate broad reactivity against a large cohort of flu strains. more...
Qitian fast RAA test kit
Xpedite Diagnostics are now suppliers of Recombinase Aided Amplification (RAA) Technology, a rapid nucleic acid isothermal method that returns results (comparable to PCR) in 8 to 15 minutes. more...
QIAGEN N.V. has announced that its NeuMoDx™ HAdV Quant Assay for the identification and quantification of human adenovirus (HAdV) DNA has received CE-IVD certification. more...
bioLytical Laboratories Inc. has announced that its INSTI® HCV Antibody Test has received approval for immediate market entry into the European Union by its Notified Body. more...
ELISA kit for Japanese Encephalitis Virus
Its peak season for JE in Asia, and control measures are having a positive effect. However, deaths are still being reported.  The JE Detect™ IgM Antibody Capture ELISA Kit is an ELISA assay system for detecting IgM in human serum to JEV-derived recombinant antigen.  more...
Crimean-Congo Hemorrhagic Fever virus ELISA Kits
ELISA Tests for Crimean-Congo hemorrhagic Fever (CCHF) virus include kits for detection of IgG and IgM antibodies against the virus and also an antigen detection test is available. Recent CCHF cases have been reported in Spain. more...
Proficiency Testing Scheme Available for SARS-CoV-2 Antigen Testing
The external quality assessment (EQA) provider UK NEQAS has launched a new proficiency testing scheme for organizations that are testing for the SARS-CoV-2 antigen or its nucleic acid by point-of-care. Next distribution dispatched 23rd August.  more...
Monkeypox virus
Creative Biogene Monkeypox Virus Real-Time PCR Kit is used to detect monkeypox virus in serum or lesion exudate samples by using real-time PCR systems. Cases have been reported in the US, UK, Israel, Singapore, and Nigeria over the last month.  more...
Soterius biosensors in use
Soterius has incorporated MIP Diagnostics' nano-molecularly-imprinted-polymers into its two-minute rapid test for COVID-19 that is currently in development. Initial results have proven extremely promising, with sensitivity in the picogram scale. more...
Saliva Rapid Antigen Test for COVID Validated for Variants
Therma Bright Inc. has announced the completion and validation that its AcuVid™ COVID-19 Rapid Antigen Saliva Test successfully detected the highly contagious, fast-moving COVID-19 Delta B.1.617.2 variant.  more...