RT-PCR – or RT-qPCR if utilizing real-time detection–delivered substantially high sensitivity and specificity.
FREMONT, CA: The pandemic has revved the uptake of point-of-care testing (POCT), with seamless, user-administered tests becoming ubiquitous in schools, workplaces, and even homes. Antigen POCT has been key in Covid-19 detection, specifically where reverse transcription PCR (RT-PCR) failed to perform. However, the usage of antigen tests isn’t always suitable due to inconsistent sensitivity.
RT-PCR – or RT-qPCR if utilizing real-time detection–delivered substantially high sensitivity and specificity. Utilizing this technology in POCT brings lab-quality outcomes to the point of need, furnishing rapid, accurate, and actionable results to clinicians.
The prompt development in the usage of POCT has driven the growth of molecular point-of-care devices. Diagnostic manufacturers have grasped this opportunity, by extending assay development beyond Covid-19 detection. The obstacle for those looking to integrate quality molecular diagnostics in a POCT device is guaranteeing accurate, reliable RT-PCR performance out of the durable and predictable conditions of a lab.
Overcoming Manufacturing Difficulties
The manufacture of molecular point-of-care devices creates revived demands for reagents and component suppliers. For instance, Glycerol-free reagents and hardy (typically thermostable) enzymes can endure demanding lyophilisation processes and following long-term, ambient depository in various devices.
To solve these challenges, determining an RT-qPCR mix with the definitive properties for POCT devices is vital.
Features and Benefits to Look Out For
Concentrated for Higher Test Sensitivity
A five-time more concentrated master mix creates beneficial space-saving benefits for miniaturised devices. Whether lyophilising within the device or fabricating a separate bead, a 5X master mix delivers higher flexibility for adding lyophilisation excipients. Reduced master mix volumes enable the formation of smaller lyophilised pellets or beads, thereby allowing miniature channels to be utilised within devices.
A One-step Protocol
The simplicity of a one-tube, one-step RT-qPCR master mix aids POCT device manufacturers by eradicating an in-house pipetting step, which is commonly the addition of an unstable reverse transcriptase to the conclusive mix just prior to use. The expulsion of this step diminishes the chance of contamination, errors, and batch-to-batch variability.