Pharmaceutical

POCT

Pharmaceutical & Manufacturing

Point-of-care testing (POCT) is defined as testing done near or at the site of patient care with the goal of providing rapid information and improving patient outcomes.

Point of care (POC) testing in communities, home settings, and primary healthcare centres is believed to have tremendous potential in reducing delays in diagnosing and initiating treatment for diseases such as HIV, tuberculosis, syphilis, and malaria. Quick diagnosis and further management decisions completed in the same clinical encounter or at least the same day, while the patient waits, promise to overcome delays associated with conventional laboratory-based testing.

South Africa has a highly centralized diagnostic landscape. Diagnostic testing in the public sector is provided by the National Health Laboratory Service (NHLS), while a handful of large diagnostic companies provide diagnostic services to private providers.

Of the 9.6 million tuberculosis (TB) cases each year, 3 million are either not diagnosed or not notified. Only one-third of the estimated patients with multidrug-resistant TB are diagnosed. Only about half of those infected with HIV are aware of their status. In half of malaria-endemic African countries, over 80% of malaria treatments are applied without diagnostic testing.

POC

Challenges related to POC diagnostics

on patient outcomes were identified by health care workers in South Africa as:

Irregular supply and stockouts of test kits
Training of health care workers on the correct use of the kits
Frequent changing of test kit brands with different performance steps
Mistrust in the quality of results
Affordability

iMed distributors have for many years being importing and distributing POC test devices from an international manufacturer and has built a strong and trusting relationship with them. Their products proved to be reliable and are ISO, CE and FDA510K approved.

In line with one of our priorities to increase accessibility of effective and sustainable POC diagnostics to resource-limited settings with poor access to laboratory infrastructure, we were successful in obtaining a contract with our trusted supplier for manufacturing the POC test devices that are already proved as providing trustworthy results, locally.

Manufacturing of the POCT in our own facility according to ISO 13485, will provide stake holding in design, evaluation, and implementation, thereby addressing many of the challenges mentioned earlier through: