This breakthrough in technology miniaturization holds great promise for improving public health, but portends a disruptive future ahead for the medical labs
Is the medical laboratory industry ready for a handheld device that can do immunoassay testing without requiring any stored energy? The secret of this device, already undergoing field trials in Rwanda, is that it uses a smartphone accessory, or “dongle,” to capture and transmit the results of the lab tests.
This innovative smartphone device accurately diagnoses HIV and syphilis with a finger prick of blood and displays the results on the smartphone screen within 15 minutes, according to a Columbia Engineering News Service report.
An Ideal Device for Field Work in Resource Poor Areas
It’s mobile and inexpensive, making it an ideal diagnostic tool for use in poor, remote regions of the world. According to World Health Organization (WHO) statistics, the highest percentages of all sexually transmitted disease (STD) cases occur in developing and underdeveloped nations. (more…)
Donor screening assays and in vitro diagnostic tests, including laboratory-developed tests, are now classified as IVDs and require a UDI label
Later this month, a new Food and Drug Administration (FDA) rule will take effect that requires unique device identifiers (UDIs) on most medical devices. This will include analyzers, instruments, and automated systems used by clinical laboratories and anatomic pathology labs.
UDIs also will apply to certain combinations of products that contain devices licensed under the Public Health Service Act (PHSA), such as donor screening assays and in vitro diagnostic (IVD) testing, including laboratory-developed tests (LDTs), noted a document describing the new law on the FDA website. (more…)
Industrial engineering firm issues “Consumer Report”-type assessment of mid-volume, automated IA and ID analyzer systems
It’s not often that pathologists and clinical laboratory managers can access a Consumer Reports-type of comparison of laboratory analyzers as they prepare to purchase new diagnostic systems. In the case of mid-volume analyzers for immunoassy (IA) and infectious disease (ID) testing, such a report is now available—and it is immediately available on the Web.
The report is titled “Using Quality Management Methods to Compare Competing Mid-Volume Segment Immunoassay Systems that Perform Infectious Disease Testing.” This report can be immediately downloaded and viewed by visiting the darkdaily.com web site.