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So…you got your Respiratory infection test results back from the doctor. Should you trust them?

Well, the answer is YES!

Why? There is a sophisticated quality assurance ecosystem supporting diagnostic testing in most healthcare systems, ensuring reliable and accurate results for you. There are several types of programs including operator training regimens, equipment calibration and verification, the use of daily quality controls checks administered within each laboratory (lab) and finally, another layer you may not have heard about – External Quality Assessment (also known as Proficiency Testing) which accredits the proficiency of the labs doing the testing. EQA for infectious diseases is a way to check the accuracy and reliability of laboratory tests used to detect and diagnose infectious diseases.

Imagine you are going for a swab sample that needs to be tested for a specific infectious disease, such as COVID-19. The laboratory where the testing is done participates in an EQA program. This program:

  1. Sends the laboratory a set of samples with known characteristics, including some that are positive for the disease and others that are negative. These samples are blinder to the laboratory.
  2. After analyzing the samples, the laboratory sends the results back to the EQA program.
  3. The EQA program compares the laboratory’s results to the known characteristics of the samples. They assess whether the laboratory correctly identified the positive samples as positive and the negative samples as negative.

If the laboratory’s results match the known characteristics, it indicates that its testing method is accurate and reliable, and the laboratory maintains its accreditation. EQA is typically conducted regularly depending on the requirements and recommendations of regulatory bodies or accrediting organizations for example annually, semi-annually, or three times a year. The specific frequency may vary based on the type of infectious disease being tested, the volume of testing performed by the laboratory, and industry standards. There are many types of proficiency samples including blood chemistry (think blood glucose level for example), autoimmune diseases, cardiac markers, etc.

Microbix is a major provider of infectious disease external quality controls to the accreditation industry, and these samples, ranging in price from about U$10 to U$50 per sample, are sold only to the accreditation companies. They are positive or negative swabs or liquid vials, covering respiratory infections, sexually transmitted infections, gastrointestinal infections, genital ulcers, and more. Samples are typically provided in sets of 3 vials (or swabs) from the disease state being tested. For example, a respiratory set might include one sample for each of SARS-CoV-2, Influenza A, and Influenza B. The accreditation organization manages the shipments to their lab customers and then collects and stores the data and reports the results back to the labs. All the samples are blinded to the testing facility, and they simply record the result for the code on the sample tested. Microbix works with global accreditation bodies such as the College of American Pathologists (CAP), American Proficiency Institute (API), WSLH (Wisconsin State Laboratory of Hygiene), Labquality, Oneworld Accuracy, Randox, and Qnostics, to name a few.

Ultimately, EQA or proficiency testing plays a crucial role in maintaining the overall quality and reliability of infectious disease testing, which is essential for effective disease control and patient care.

Isn’t it good to know there are external, reputable organizations that help check the performance of the labs returning results to their customers?

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