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2021, Cilt 19, Sayı 1, Sayfa(lar) 056-062
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Evaluation of Analytical Quality of Fertility Function Tests with Sigmametric Method
Tuğba Öncel, Mehmet Hicri Köseoğlu, Hayat Özkanay Yörük, Ayşenur Atay, Leyla Demir, Figen Narin
Katip Çelebi Üniversitesi Atatürk Eğitim Araştırma Hastanesi, Tıbbi Biyokimya Anabilim Dalı, İzmir, Türkiye
Keywords: six sigma; laboratory; hormone

Aim: Sigmametric methodology is used as a quality management tool that predicts variables can be controlled and targets zero error.In this study, sigmametrics were calculated for some fertility function tests to pick the suitable quality control tools and approach for sigmametrics.

Materials and Methods: The performance of fertility function tests[luteinizing hormone (LH), follicle stimulating hormone (FSH), estradiol (E2), progesterone,prolactin (PRL), human chorionic gonadotropin (HCG)] was calculated based on data of 3-months period (January-February-March 2019) in Katip Çelebi University Atatürk Education and Research Hospital. %CV (coefficient of variation) values were calculated by obtaining 2-level internal quality control data from Advia Centaur XP analyzer.The data for the %Bias calculation was taken from EQAS (External Quality Assurance Services) program. The total allowable error values were taken from CLIA (ClinicalLaboratoriesImprovementAct)-2019 database. The sigmametrics of quality control levels were calculated separately by using %CV, %bias, and total allowable error data.

Results: The sigmametrics for E2 for low and high levels were 4.4 and 5.3; the sigmametrics for FSH were 4.04 and 3.5 respectively. The sigmametrics for LH were 3.87 and 4.45, the sigmametrics for the PRL were 6.4 and 5.6 respectively. The sigmametrics for HCG were 2.1 and 3.1, the sigmametrics of progesterone were 2.8 and 3.1 respectively.

Conclusion: Whilst sigmametric for low level control of prolactin shows the highest performance by 6.4; the sigmametric for low level control of HCG showed the lowest performance by 2.1. It would be appropriate to take precautions to increase the method performance for the parameters with a sigmametric of less than 3. The 13S/22S/R4S/41S/8x Westgard rules should be used for HCG and progesterone parameters and 2 level quality control measurements should be carried out twice a day.


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