Evaluation of in-house internal quality control samples for serum indices

  • Phạm Viết Tân Bệnh viện Trung ương Quân đội 108
  • Đinh Thị Thảo Bệnh viện Trung ương Quân đội 108
  • Nguyễn Cẩm Thạch Bệnh viện Trung ương Quân đội 108
  • Hoàng Thu Hà Bệnh viện Xanh Pôn
  • Trần Thị Chi Mai Bệnh viện Nhi Trung ương

Main Article Content

Keywords

Internal quality control samples, serum indices, 108 Military Central Hospital

Abstract

Objective: To identify the homogeneity and stability of in-house internal quality control samples (IQC) for serum indices at Biochemistry Department, 108 Military Central Hospital. Subject and method: A 1200ml normal plasma sample pool that was clear, light yellow, having serum indices values: < 0.25 index for hemolysis, < 30.0 index for icteria, < 0.3 index for lipemia, respectively and 3 types of plasma samples: 150ml plasma with artificial hemolysis, 150ml plasma with over 360μmol/L total bilirubin concentration, 150ml plasma adding 20% intralipid up to triglyceride concentration of 20mmol/l. The IQC samples for HIL indices were prepared by mixing these previous plasma samples with normal plasma sample pool at 1: 1 ratio, including 3 levels: High, medium, low concentrations. Evaluation of short-term (20 days) and long-term (90 days) stability of the IQC samples was based on CLSI EP05-A2 guidelines. Result: For the homogeneity: There was no difference of HIL values of all IQC samples between 2 analysis for each concentration, p>0.05. The IQC samples were stable at 4oC for 20 days (CVr 0.2 - 4.15, CVt 0.18 - 4.64), at 4oC for 90 days (CVr 0.19 - 4.51, CVt 0.17 - 4.72), at -20oC for 20 days (CVr 0.15 - 2.96, CVt 0.14 - 3.14), and at -20oC for 90 days (CVr 0.14 - 2.79, CVt 0.14 - 3.23). Conclusion: The in-house IQC for HIL indices ensured the homogeneity, short-term stability (20 days) and long-term stability (90 days) at 4oC and -20oC storage.

Article Details

References

Forsman RW (1996) Why is the laboratory an afterthought for managed care organizations?. Clinical Chemistry 42(5): 813-816.
2. Ramsey CA and Wagner C (2015) Sample quality criteria. Journal of AOAC International 98(2): 265-268.
3. Gils C, Frederiksen H, and Nybo M (2017) Hemolysis-icterus-lipemia index analysis: A national survey on the validation and use on automated equipment. The Journal of Applied Laboratory Medicine 1(4): 450-452.
4. Miller Wg, Erek A, Cunningham TD et al (2011) Commutability limitations influence quality control results with different reagent lots. Clinical chemistry 57(1): 76-83.
5. Lippi G, Cadamuro J, von Meyer A et al (2018) Local quality assurance of serum or plasma (HIL) indices. Clinical biochemistry 54: 112-118.
6. ISO, ISO 13528: Statistical methods for use in proficiency testing by interlaboratory comparison. 2015, Switzerland: International organization for standardization.
7. Gabaj NN, Miler M, Vrtarić A et al (2018) Precision, accuracy, cross reactivity and comparability of serum indices measurement on Abbott Architect c8000, Beckman Coulter AU5800 and Roche Cobas 6000 c501 clinical chemistry analyzers. Clinical Chemistry and Laboratory Medicine (CCLM) 56(5): 776-788.
8. Guder WG, da Fonseca-Wollheim F, Heil W et al (2000) The haemolytic, icteric and lipemic sample recommendations regarding their recognition and prevention of clinically relevant interferences. Recommendations of the Working Group on Preanalytical Variables of the German Society for Clinical Chemistry and the German Society for Laboratory Medicine. LaboratoriumsMedizin/Journal of Laboratory Medicine 24(8): 357-364.
9. Nikolac N (2014) Lipemia: Causes, interference mechanisms, detection and management. Biochemia medica 24(1): 57-67.
10. Chiu N and Christopoulos TK (2012) Advances in immunoassay technology. BoD–Books on Demand.
11. Grafmeyer D, Bondon M, Manchon M et al (1995) The influence of bilirubin, haemolysis and turbidity on 20 analytical tests performed on automatic analysers. Clinical Chemistry and Laboratory Medicine 33(1): 31-52.
12. Institute CLS (2012) Hemolysis, icterus, and lipemia/turbidity indices as indicators of interference in clinical laboratory analysis; approved guideline. CLSI C56-A document. Clinical Laboratory Standards Institute Wayne, PA 32(10).
13. Lippi G et al (2018) Internal quality assurance of HIL indices on Roche Cobas c702. PloS ONE 13(7): e0200088.