Hycor & Changsha Haike attain HMPA approval for ALLEOS 2000
Hycor and biomedical partner Changsha Haike gain registration from HMPA for ALLEOS 2000 system
GARDEN GROVE, Calif. & KASSEL, Germany—Hycor Biomedical, a manufacturer of in vitro diagnostic products for allergy testing, and Changsha Haike Biotechnology Co., Ltd., Hycor’s Chinese manufacturing partner, have achieved registration from the Hunan Medical Products Administration (HMPA) for the ALLEOS 2000 allergy testing system. ALLEOS 2000 was approved on August 4.
“The registration of ALLEOS 2000 underscores our commitment to drive allergy immunodiagnostics into the 21st century,” said Dr. Fei Li, president and chief executive officer of Hycor Biomedical. “China is a very important market for HYCOR. We will continue to work closely with Changsha Haike to provide a broad and strategic allergy diagnostic menu for China.”
“ALLEOS 2000 leverages advanced technology developed for the NOVEOS system as well as the extensive know-how and expertise from Hycor’s 40 years of experience in allergy diagnostics. The novel system offers Chinese laboratorians and clinicians an opportunity to adopt a high-throughput automated system that requires only 4ml sample volume, yet also provides accurate allergy test results,” noted Dr. Hao Zou, CEO of Changsha Haike. “We are very excited to launch the ALLEOS 2000 instrument and we have no doubt this innovative allergy diagnostic system will enable improved patient management. This is especially important in pediatric populations where sample volume can be restrictive.”
Hycor Biomedical also announced back in June that the National Institute for Public Health and the Environment (RIVM) had released the results for the evaluation of the NaGene COVID-19 direct PCR kit for SARS-CoV-2 detection. Hycor Biomedical has partnered with Beijing NaGene Diagnosis Reagent Co., Ltd. to provide high quality direct RT-PCR test solutions.
The evaluation found that direct RT-qPCR may be an attractive alternative to current extraction-based qRT-PCR used for laboratory confirmation of SARS-CoV-2 infection, when using NaGene Preservation Buffer (PB). This was proven during a sampling study conducted to compare two different transport media (GLY and Preservation Buffer).
In nasopharyngeal swab specimens obtained from hospitalized COVID-19 patients, Ct values were lower for the clinical specimens stored in PB when compared to the same clinical sample collected in GLY medium. Collection in PB also significantly increased the sensitivity when compared to the benchmark in-house E-gene qRT-PCR using GLY transport medium.
In combination with the supplied Preservation Buffer, the NaGene kit reportedly provides a quick result and an accurate alternative to extraction-based qRT-PCR for SARS-CoV-2 detection assays.