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Point of care (POC) testing has revolutionized the way we diagnose and manage various infectious diseases, including sexually transmitted infections (STIs). The ability to obtain rapid, accurate results from POC tests has led to improved patient outcomes, reduced treatment delays, and decreased transmission rates. However, as with any diagnostic test, accuracy and reliability are critical factors that must be taken into consideration. This is where external quality controls come into play. In this blog post, we will explore the importance of External Quality Controls in POC testing and how Microbix’s Quality Assessment Products (QAPs™) can provide a solution to ensure accuracy and reliability in STI diagnostics.
Importance of Diagnostic Accuracy in STI Testing:
STIs are a significant public health concern, with millions of new cases reported each year. Accurate diagnosis and timely treatment are essential for preventing the spread of STIs and reducing long-term complications. Traditional laboratory testing for STIs can be time-consuming, require specialized equipment and training, and may not always be accurate. For example, Chlamydia and gonorrhea testing may involve culturing the bacteria, which can take several days to produce results. In contrast, POCT devices for Chlamydia and gonorrhea can provide results in as little as 30 minutes. In addition, POCT devices that use nucleic acid amplification tests (NAATs) have been shown to be highly sensitive and specific, making them a promising tool for improving diagnostic accuracy in STI testing.The use of POC tests for STI diagnosis has become increasingly popular due to its ease of use and rapid results. However, the accuracy of these tests is of utmost importance, as false-negative or false-positive results can have serious consequences.
Impact on patient outcomes and public health:
There have been several instances where the lack of assurance of point of care and not using external quality controls in a lab setting has resulted in serious consequences for instance, In 2015, a laboratory in New Jersey, USA was found to have issued false negative results for HIV tests. The lab had not been using proper quality controls and had not followed the manufacturer’s instructions for running the tests. As a result, many patients were incorrectly diagnosed as negative for HIV and were not given appropriate treatment. Furthermore, , In 2018, a laboratory in India was found to have issued incorrect diagnoses for tuberculosis. The lab had not been using external quality controls which led to many patients being incorrectly diagnosed and given incorrect treatment.
Adding Microbix’s Quality Controls to your laboratory workflow:
For molecular diagnostic platforms, such as PCR-based tests, internal controls are often included in the test. These internal controls act as a check for the amplification and detection processes of the assay. However, it is crucial to use external controls as well, as they can verify the entire assay process, including nucleic acid extraction and purification.
Microbix offers a range of QAPs™ for POC testing for STI, including Chlamydia trachomatis, Neisseria gonorrhoeae, Human papillomavirus (HPV), Syphilis, and Mycoplasma genitalium. These quality controls are manufactured to the highest standards and are available for a variety of POC test platforms, including lateral flow assays and molecular diagnostic tests. These controls are designed to mimic real patient samples, are easy and ready to use, come in a variety of sample types, and have a long shelf life, making them an ideal choice for onboarding, research use only samples or IVD controls.
Our controls are FDA Registered, Health Canada Approved, CE-Marked and TGA Registered. Find our distributor in a city near you.
To learn more, download a microbix catalogue here or request a quote here.