The test principle of DiaSys' oneHbA1c FS is based on binding of total Hb and HbA1c to latex particles in R1 with similar affinity. The amount of binding is proportional to their relative concentration in blood. Anti-HbA1c antibodies (R2) specifically bind to HbA1c, interact with polyclonal antibodies after addition of R3 and cause agglutination. The measured absorbance is directly proportional to the HbA1c concentration in the sample.

Recently a 2-point application guideline for oneHbA1c FS reagent was recommended by DiaSys Diagnostics Systems. This 2-point application in combination with oneHbA1c FS reagent shows excellent precision, reproducibility and outstanding comparison to Biorad D10 (HPLC). Many customers are running samples and they are highly satisfied with the comparison data.

We are pleased to present you some validation results obtained at valuable customer places and as well a satisfaction letter from Dr. Rohini Kalhan, MBBS, MD, Director of Alaknanda Diagnostic Lab (NABL Assessor), New-Delhi, India.

Tab.1: oneHbA1c FS in combination with the 2-point application on respons®910 compared against HPLC.

Both validation sites confirmed an outstanding correlation of DiaSys' oneHbA1c FS to HPLC (r=0.9951). These results could also be verified by Sri Krishna Sevaasraman Hospital, Bangalore, India.

Moreover, we received a letter of satisfaction on the performance of oneHbA1c FS from the reputed Dr. Rohini Kalhan, MBBS, MD, Director of Alaknanda Diagnostic Lab (NABL Assessor), New-Delhi, India. Dr. Rohini Kalhan emphazisized the accuracy, precision and excellent comparability of oneHbA1c FS reagent in combination with the 2-point application.

DiaSys' oneHbA1c FS assay reveals outstanding specificity and precision. This test correlates very well to HPLC (NGSP/DCCT) and IFCC reference material. DiaSys’ oneHbA1c FS assay directly determines HbA1c concentration in a single measurement, thereby exceeding international requirements with an excellent precision of a CV < 2% over the entire measuring range. The CE marked 2-point application will be available within the next weeks. DiaSys would like to thank all validation sites for their successful cooperation!