International Journal of Pharma and Bio Sciences
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10.22376/ijpbs.2019.10.1.p1-12
Volume 9 Issue 3
2018 (July-September)
Preparation of pooled blood samples to use as a proficiency Testing material for hemoglobin a1ctesting byturbidimetric Inhibition immunoassay
Hemoglobin A lessThan sub greaterThan 1c lessThan /sub greaterThan (HbA lessThan sub greaterThan 1c lessThan /sub greaterThan ) or glycated hemoglobin testing is used to monitor the degree of glucose metabolism in diabetic patients. This study aims to evaluate pooled whole blood samples are available proficiency testing materials (PT materials) for HbA lessThan sub greaterThan 1c lessThan /sub greaterThan testing by turbidimetric inhibition immunoassay(Indiko™).The constituent whole blood samples, taken from 30 diabetic patients, were left over from routine laboratory work.The specimens were divided into two groups, Group 1 (n=15) diabetic patient specimens with normal hemoglobin, and Group 2 (n=15) diabetic patient specimens with low hemoglobin (Hb lessThan 12 g/dl).From each group, the samples had different HbA lessThan sub greaterThan 1c lessThan /sub greaterThan levels, 4.0 - 6.4, 6.5 – 9.9 and 10.0 – 14.0%, each level had pooled of five original samples. After that, the samples were washed and suspended in citrate phosphate dextrose adenine 1 (CPDA1). Then,samples were randomly selected for homogeneity and stability testing at stored 2-6 lessThan sup greaterThan 0 lessThan /sup greaterThan C and -20 lessThan sup greaterThan 0 lessThan /sup greaterThan C, in accordance with ISO 13528: 2015 Annex B.Coefficient of variation (CV) of within a run and between a run of HbA1c were range from 1.48% to 1.73% for quality control level 1 and 2.Blood materials prepared from both groups of Hb were homogeneous and could stable for at least 15 days at 2-6 lessThan sup greaterThan 0 lessThan /sup greaterThan C and -20 lessThan sup greaterThan 0 lessThan /sup greaterThan C.Blood materials from pooled whole blood sample suspended in CPDA1 solution were stable at least two weeks at 2-6 lessThan sup greaterThan 0 lessThan /sup greaterThan C and -20 lessThan sup greaterThan 0 lessThan /sup greaterThan C by turbidimetric inhibition immunoassay and also avoidobtainable volume from diabetic patients.Moreover, further studies are required to estimate of PT material on multiple assays.
P.WONGSRI, K.KONGROS, P. SAKAEW AND
W.TREEBUPHACHATSAKUL.
hemoglobin A1c, homogeneity test, stability test, proficiency testing.
98-103