What is the NGSP and why is it important for patients with diabetes?
Author: Laboratorio Clínico Hematológico. Date of publication: 8 /11/2023
On the occasion of our certification as a level I laboratory for the glycated hemoglobin test for the sixth consecutive time, we would like to share information about the NGSP quality control program. This program guarantees the accuracy and reliability of this test, which is fundamental in the control of diabetes and the prevention of its complications.
1. What is the NGSP?
NGSP stands for National Glycohemoglobin Standardization Program. National Glycohemoglobin Standardization Program, which was the original name of this program for the harmonization of the harmonization of HbA1c testing, which was established in 1996 following an initiative in the United States to define a standardized assay for HbA1c testing. standardized test for the measurement of glycated hemoglobin, which could be used in all laboratories worldwide and for any population.
This, through the certification of methods that are traceable and traceable with two important studies carried out in patients with diabetes mellitus: the "Diabetes Control and Complications Trials (DCCT)" y "United Kingdom Prospective Diabetes Study (UKPDS)", in which glycated hemoglobin values representing a risk for the development and progression of chronic vascular and degenerative complications of diabetes were established.
As the program grew and became international in scope, the official name was shortened to the acronym NGSP.
2. What do you mean by standardize?
There are different methods for the assessment of glycated hemoglobin in a clinical laboratory; for example, in Hematology we use the high performance liquid chromatography (HPLC) method; however, for the results obtained to be clinically useful, they must be reproducible, regardless of the method or where the measurement is made.
When we talk about standardizing we refer to a rigorous process that establishes the fundamental parameters by which a method of assessing a test in a laboratory, which in this case is glycated hemoglobin, conforms to pre-established parameters and demonstrates that it is adequate to results that give us the confidence that they truly represent the blood sugar levels of patients and thus allow us to diagnose the and thus allow us to diagnose prediabetes, diabetes, or define the risk of developing or progressing developing or progressing chronic complications of diabetes. This allows a common language to be spoken among laboratories.
Once the valuation method is standardized, it should ideally be subjected to continuous monitoring by means of the use of the use of quality controls of the test and comparison tests between the method itself and the one performed by a reference laboratory, in order to quickly adjust the identified points of improvement. In this case we do it with the NGSP.
To learn about the concepts of "traceability" and "harmonization", which are closely related and sometimes confused with the standardization process in the context of glycated hemoglobin, please click here .
What does the NGSP program consist of?
The program consists of a network of reference laboratories that are part of and authorized by the NGSP, whose method of measuring glycated hemoglobin is adjusted to the international studies mentioned (DCCT and the UKPDS), which are responsible for monitoring the individual participating laboratories, such as ours.
What they do is process a series of fresh blood samples, with which they establish the initial glycated hemoglobin data for standardization (calibration) of methods and assays for comparison of results. These same samples are then sent for processing in our laboratory, with the analysis equipment and measurement method for glycated hemoglobin that we routinely use for testing our patients.
Once processed, the results are sent to the NGSP to be verified and assessed by members of the program. Once it is confirmed that our results for glycated hemoglobin are concordant with those of the reference laboratory, i.e., that they are within the parameters established by the program, they issue a Certificate of Traceability.
4. What was the certification that the Hematologic received from the NGSP and why is it important?
The NGSP offers three types of certification: method certification, Level I laboratory certification and Level II laboratory certification, to those laboratories that successfully complete the evaluation process. This is done on an annual basis and specifically for the reagents and instruments used for Hb1Ac titration of submitted samples. For level I laboratories, a quarterly monitoring is also performed, which allows a quick detection of eventual difficulties with the test.
At Hematology, our Hb1Ac titration technique has met the NGSP evaluation criteria to achieve traceability certification and as a level I laboratory. traceability certification and as a level I laboratory for the for the study of diabetes, for the sixth year in a row. This is a very important certification for us because it indicates that our results are comparable, reproducible and give us accurate information on the risk of complications in patients with diabetes.
We are all proud to have obtained this certification for the years 2022-2023, as it is the result of the joint work between the team that participates in the process, the bacteriologists, the quality assurance coordination and the laboratory coordination, which fills us with great satisfaction.
NGSP in the Laboratorio Clínico Hematológico
In Colombia, the Hematológico was the first laboratory to be part of the NGSP program and to receive of the NGSP program and to receive level I. Thanks to this, we can provide our physicians and patients with glycated hemoglobin results with maximum reliability for the study and follow-up of diabetes. Currently, only We would like to congratulate all those who are part of this process and invite them to continue working to provide quality services, humanized and supported by a high level human team.
Learn more about the medical utility of the glycated hemoglobin test by clicking here.
