Clinical Validation of Bioperfectus Monkeypox Virus (MPXV) Fast Real Time PCR Kit

Company news
2022-11-07

SHANGHAI, CHINA, September 30, 2022—Jiangsu Bioperfectus Technologies Co., Ltd. (hereinafter referred to as “Bioperfectus”) applied for the clinical evaluation in XYZ Laboratory (XYZ Laboratory 2009 Ranch Rd. 620 N, STE 325, Austin, TX 78732, USA), a CAP accredited CLIA certified high complexity clinical molecular diagnostic laboratory to perform and report the Bioperfectus Monkeypox Virus (MPXV) Fast Real Time PCR Kit.

 

“In this study, we have performed a systematic evaluation of the analytical performance of the Bioperfectus Monkeypox Virus (MPXV) Fast Real Time PCR Kit. The assay is highly sensitive, fast, and easy to use. This study has established the specification of the assay when used in a CLIA certificated high complexity Laboratory:

The clinical performance: 97.43% PPA* and 100% NPA*.”

*Positive percentage of agreement (PPA), Negative percentage of agreement (NPA) 

 

With real clinical samples tested, the validation result shows solid evidence that Bioperfecuts Monkeypox Virus (MPXV) Fast Real Time PCR Kit has high clinically qualified sensitivity and specificity to fulfill the virus detection and diagnosis requirement in PCR laboratories. Positive control and negative control were validated, allowing the interpretation of the results.

 

(If you need more information about the evaluation report, please email us at info@bioperfectus.com)

Since the Monkeypox outbreak in several originally non-endemic countries in May, it has affected over 100 countries with almost 80,000 confirmed cases and 38 deaths. With rapid response, reliable and trustworthy performance, Bioperfectus has always stuck to the first line of fighting against infectious disease outbreaks as a manufacturer specializing in molecular diagnosis for over a decade. So far, over 200,000 test kits have been delivered to over 100 countries around the globe. 

 

Bioperfectus Monkeypox Virus Diagnostic Solution has been validated, approved, and used to test and track the Monkeypox virus in several high and key-level public and private laboratories worldwide.

 

MOST READ

Bioperfectus Granted MDA Approval in Malaysia for Nucleic Acid Extraction Systems

SHANGHAI, CHINA, November 14, 2022—Jiangsu Bioperfectus Technologies Co., Ltd. (hereinafter referred to as “Bioperfectus”), a leading global company in the molecular diagnostics market, today announced receipt of MDA (Medical Device Authority) approval in Malaysia for Nucleic Acid Extraction Systems, including Nucleic Acid SSNP-2000B, SSNP-3000A, SSNP-9600A, SMPE-960 and Extraction Rapid Kit (Magnetic Bead Method).

2022-11-14

The COVID-19 is Delaying the Cervical Cancer Screening

Human papillomavirus (HPV) is the primary cause of cervical cancer, which is preventable through screening and early treatment. The elimination of cervical cancer has been defined by the WHO as achieving an incidence rate below 4 cases per 100,000 women per year since 2020.

2022-10-25

Bioperfectus Emergency Response Training for Ebola Virus Diagnostics and Testing

Bioperfectus conducted emergency training to assist frontline healthcare professionals in Uganda using Real-Time PCR diagnostic tools for early detection and control of the latest Ebola outbreak.

2022-10-19