Development of In-House HCG, Protein, and Glucose in Urine Control Material for Quality Assessment in Primary Care Units in the Saraburi Hospital Network

Abstract

The urine pregnancy, protein and glucose strip tests are commonly used as point-of-care testing (POCT) which are convenient and rapid for medical laboratory diagnosis. However, the assessment of accuracy and precision in tests along with the patient’s safety is needed. This study aimed at preparation of the In-House control materials for urine human chorionic gonadotropin (hCG) and protein-glucose strip tests, and subsequent usage for the proficiency testing among primary care hospitals network in Saraburi province. The pooled urine sample from excess specimen in routine laboratory was prepared and levels of hCG, protein and glucose were adjusted. The prepared urine sample was preserved at 4 ^oC by the addition of boric acid to the final concentration 10 g/L which effectively retained stability of hCG and protein for at least 15 days, and glucose within 9 days. Moreover, mixing of 10 g boric acid and 10 mL anticoagulant citrate dextrose (ACD) in 1 liter of urine could maintain hCG, protein, and glucose levels by at least 15 days. This In-House control urine was further shown acceptable qualities by evaluations of homogeneity and stability testing and could be kept at 4 ^oC for at least 15 days. Then, two-level standard urine samples were subjected to 2 rounds of proficiency testing in urine hCG, protein, and glucose strip tests among 126 Saraburi province’s primary care hospitals network. The interlaboratory comparison for all tests was satisfactory. In summary, the prepared In-House control urine is suitable to use in proficiency testing program and the procedure will likely reduce the cost of quality management.