Fapon's Mpox Antigen Detection Product Shows Unparalleled Sensitivity of Below 1 pg/mL in Positive Clinical Specimens

Original from: PR Newswire

In the face of the escalating mpox outbreak, health authorities worldwide are on high alert, particularly with the emergence of the more contagious and aggressive clade Ib. The surge in cases has intensified the need for rapid and accessible diagnostic tools to curb the spread of the virus.

In response to this challenge, Fapon Biotech, a world leading in-vitro diagnostics (IVD) total solution provider, has been in close communication with related organizations such as Africa Centres for Disease Control and Prevention (Africa CDC) and the Foundation for Innovative New Diagnostics (FIND) to discuss better diagnostic solutions. Fapon Biotech has not only upgraded its mpox antigen detection products but also meticulously validated their performance against positive samples with an authoritative institution. The upgraded product achieves a breakthrough detection limit of below 1pg/mL for both Clade I and II recombinant antigens.

The validation experiment results have confirmed the product's performance to detect diluted mpox virus culture samples at a minimum titer of 6.25Pfu/mL (with a Ct value of 30 verified by a team of virologists from a leading national clinical research institution in China).

Clinical validation results of 22 clinical specimens from patients with mpox showed that the majority of samples were detectable, and judging from the chromatographic color intensities of the detected specimens, the detection Ct values were also around 30.

This rapid and convenient diagnostic tool is poised to make a significant impact on managing the outbreak in affected regions, particularly in regions where healthcare facilities may be limited. On August 29, the WHO called for global IVD manufacturers to submit applications for Emergency Use Listing (EUL) to expedite the rapid access to diagnostic tests for mpox. FIND has also issued a Request for Proposals (RFP) for mpox diagnostics, offering additional resources to support performance evaluation and accelerate product development.

Source: Fapon's Mpox Antigen Detection Product Shows Unparalleled Sensitivity of Below 1 pg/mL in Positive Clinical Specimens