World Health Organization Issues Target Product Profile for Infant Infection Dx

Original from: 360dx

The World Health Organization this week issued a target product profile report for in vitro diagnostic tests to detect serious bacterial infections in newborns and babies aged 2 months and younger.

"Timely and accurate diagnosis tests for serious bacterial infection is critical to reducing newborn mortality," Yvan Hutin, director of the department of antimicrobial resistance at WHO, said in a statement. 

Diagnostics for infections in general, and bacterial sepsis in particular, in very young infants are considered either inadequate or entirely lacking in many global settings, the authors of the profile wrote. For example, blood culture-based tests tend to be slow and lacking in sensitivity, while molecular and host response biomarker assays can be costly, with the latter also contraindicated as a standalone test.

"There is a need for an accessible and affordable standalone test for serious bacterial infections that can provide clear and rapid actionable results from low-volume specimens, and which is suitable for use in both hospital and nonhospital health facilities across income settings," the report authors wrote.

Within primary care, an IVD for infant infections could help clinicians identify cases that require a referral to a hospital, while at the hospital, an IVD could help guide appropriate treatment.

The new TPP lays out the essential and desirable characteristics of in vitro diagnostics for early, accurate diagnosis among infants aged up to 59 days in either primary healthcare settings or in higher level healthcare facilities. 

According to the target test profile, a test should run on a portable device using less than 100 microliters of capillary whole blood, require less than 10 minutes of hands-on time, and have a turnaround time of less than 30 minutes. It should also deliver conclusive results 95 percent of the time, with a clinical sensitivity and specificity in nonhospital settings of at least 90 percent and 70 percent, respectively, and with at least 80 percent specificity in hospital settings. 

The report further details additional size, power, storage, data connectivity, and other requirements. 

"Pricing from manufacturers should be as low as sustainably possible while maintaining quality, based on evidence of the cost of goods sold, accounting for material, manufacturing process, operational logistics, and commercialization efforts," the authors wrote, and suggested a list price of $5 or less per test.

Intended to be used by stakeholders who develop and implement diagnostic technologies, the TPP was developed by WHO's departments of AMR, research for health, and maternal, child health, and aging, with contributions from FIND and other partners, and financial support from the UK and Saudi Arabia. 

The WHO also released a technical document last month aimed at improving usability of rapid point-of-care and at-home diagnostics.

Source: World Health Organization Issues Target Product Profile for Infant Infection Dx