QIAGEN's NeuMoDx HIV-1 Quant Assay Approved in Thailand for BBV Testing

15 April 2024 | Monday | News


QIAGEN announced that its NeuMoDx human immunodeficiency virus type 1 (HIV-1) assay has received approval for use in Thailand. Along with the previously approved hepatitis B virus (HBV) and hepatitis C virus (HCV) quantitative assays there is now a full complement of blood-borne virus (BBV) assays available in Thailand.

  • The registration of the NeuMoDx HIV-1 Quant assay completes the suite of BBV testing in  Thailand using the fully automated NeuMoDx™ platform 
  • NeuMoDx BBV Quant assays offer reliable and accurate viral load monitoring as an aid in the  clinical management of patients with HIV-1, HBV, HCV 
  •  The NeuMoDx platform delivers fast turnaround times utilizing an intuitive 3-step workflow  for informed clinical decisions

 

Every day, millions of patients infected with blood borne viruses such as HIV, HCV and HBV require routine  testing to quantify their viral load in order to help assess the need to start, modify or stop antiviral therapy. These assays make use of QIAGEN’s fully automated NeuMoDx molecular platform that extracts and  purifies DNA or RNA from blood to isolate the target nucleic acids and then conduct a real-time polymerase  chain reaction (RT-PCR). 

The NeuMoDx HIV-1 Quant Assay is designed for the quantitation and detection of human  immunodeficiency virus type 1 (HIV-1) RNA in human plasma. It can be used as an aid in the clinical  management of HIV-1 infected patients and monitoring the effects of anti-retroviral treatment, as measured  by changes in plasma HIV-1 RNA levels, and as an aid in the diagnosis of HIV-1 infection, including acute  or primary infection. 

The NeuMoDx HBV Quant Assay is designed for the quantitation of hepatitis B virus (HBV) DNA in human  plasma and serum specimens for HBV genotypes A through H of HBV-infected individuals. It is intended to  be used as an aid for determining proper course of treatment for patients with HBV infection. 

The NeuMoDx HCV Quant Assay is designed for the quantitation of hepatitis C virus (HCV) RNA genotypes  1 through 6 in human plasma and serum specimens from HCV antibody positive individuals. It is intended  to be used as an aid in the management of patients with HCV infections. 

NeuMoDx has a simple and intuitive 3-step workflow. Room temperature stable test strips, universal reagents and consumables are ready-to-use and can remain on board for a minimum of 7 days. The  NeuMoDx system is always ready to run with minimal maintenance and waste generation. It offers true  random access testing capabilities and up to 8 hours walkaway time. The system can run up to 30 different  assays and offers the versatility to run in-vitro diagnostics (IVD) certified assays, self-developed tests (SDTs)  and RUO assays. 

”The approval of NeuMoDx HIV-1 quantitative assay now allows testing for the full complement of BBV  assays available on NeuMoDx, providing a significant benefit for patients with accurate and timely results. The test will play a vital role in controlling the spread of these diseases, addressing major needs for clinical testing in infectious diseases,” said Pimlada Sirichadkulburdee, National Sales Manager, Thailand, at  QIAGEN. 

Along with blood-borne viruses, the NeuMoDx system has assays available for transplant-associated  viruses, sexual and reproductive health as well as respiratory diseases. 

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