NOT ALL HEROES WEAR CAPES
I’m sure everyone is aware of how hard our PTS family in Sunnyvale works every day to provide our A1CNow solutions to customers around the world. But few people are aware of two very important, and time-consuming projects that the Sunnyvale team must perform every year to maintain our National Glycohemoglobin Standardization Program (NGSP) and International Federation of Clinical Chemistry and Laboratory Medicine (IFCC) certifications. In order to learn more about this, Charles Xie M.D., Director of Research & Development (Sunnyvale) was kind enough to spend some time with me.
Who/what are NGSP and IFCC?
The purpose of the NGSP is to standardize Hemoglobin A1c test results to those of the Diabetes Control and Complications Trial (DCCT) and United Kingdom Prospective Diabetes Study (UKPDS). The purpose of the IFCC Network for Standardization of HbA1c is to standardize HbA1c test results to the IFCC Reference Measurement Procedure. Basically, both organizations set standards to ensure that manufacturers’ test results have acceptable accuracy and precision. Both organizations compare the results of the testing to the results obtained by a reference lab, or “gold standard”.
Why does this matter? We test our products to ensure they are accurate and precise.
It matters very much to our customers. These certifications provide assurance that our tests perform to internationally accepted, traceable standards. If each test manufacturer had a different way to measure accuracy and precision, there could be both unpredictable and unreliable results for their patients.
How is this testing performed and how often?
The testing is done on an annual basis. Both organizations require samples of whole blood (either procured by us or given to us). For NGSP, we must run 40 samples and compare the results with a Secondary Reference Laboratory (SRL) associated with NGSP. In 2019, the NGSP certification criteria was tightened from 37 of 40 results within ± 6% to 36 of 40 results within ± 5%. This has made it difficult for many A1C manufacturers, but PTS has received our certificate in 2019 and again in 2020. For IFCC, we must run the tests based on samples that are given to us. The same samples are used for all companies. Our results of precision and accuracy are compared with a high-level reference lab. IFCC is measured a little differently. They tell us the performance of our test’s accuracy and precision across the whole range of A1C values. We obtain both certifications because individual countries may accept one but not the other. IFCC certification is a requirement for PTS to sell A1CNow in all EU countries.
By now you can see how complex and time consuming it must be for our heroes in Sunnyvale to perform these tests every year. It is vitally important to our customers and the patients we serve. I would personally like to thank the entire team in Sunnyvale for everything they do to ensure we continue to deliver high-quality product that meets the high standards set for our industry.