Serum tirotropin için biyolojik varyasyon bileşenleri ve kalite spesifikasyonlarının belirlenmesi

Year 2020, , 284 - 289, 14.05.2020

Müjgan Ercan , Emiş Deniz Akbulut Adnan Kirmit

https://doi.org/10.31362/patd.647255

Abstract

Amaç:
Serum tiroid hormon düzeyleri tiroid hastalıklarının tanı ve takibinde
kullanılır. Bu çalışma serum tirotropin (TSH) için biyolojik varyasyonu (BV)
hesaplanması ve değerlendirilmesini amaçlamaktadır.

Gereç ve yöntemler:
Kan örnekleri, sekiz gönüllüden (dört kadın, dört erkek; yaşları 20-35 arasında
değişen) beş hafta boyunca, haftalık olarak alındı. Serum TSH seviyeleri Abbott
Architect ci8200  immunassay cihazında
ölçüldü ve Biyolojik varyasyon (BV) hesaplamaları Fraser’ın yöntemine göre
nested ANOVA testi kullanıldı.

Bulgular: Serum TSH için hesaplanan analitik
varyasyon (CV_A), birey içi BV (CV_I), bireylerarası BV (CV_G),  bireysellik indeksi (II) ve referans değişim
değeri (RCV) değerleri sırasıyla  %
5.4,  % 26.2,  % 26.9, 
0.99 ve % 74.2 idi.  Belirsizlik, bias ve izin verilen toplam hata (TEA)
için istenen performans hedefleri sırasıyla <% 13.1, <% 6.7 ve <% 28.3
idi.

Sonuç: BV
veri tabanındaki (CV_I =% 19.3 ve CV_G =% 24.6) sonuçlar
ile karşılaştırdığımızda Serum TSH için elde ettiğimiz CV_I ve CV_G
değerleri daha yüksek olduğunu tespit ettik. TSH’ın takibi sırasında sonuçların
değerlendirilmesi için hesaplanan düşük II, TSH bireyselliğinin daha belirgin
olduğunu ve toplum bazlı referans aralıklarının daha az kullanışlı olduğunu
gösterir.

Keywords

TSH, biyolojik varyasyon, birey-içi biyolojik varyasyon, bireyler-arası biyolojik varyasyon, referans değişim değeri

Determination of biological variation components and quality specifications for serum thyrotropin

Abstract

Purpose: Serum thyroid hormone levels are used in the diagnosis and follow-up
of thyroid disorders. The present study aims calculation and
evaluation of biological variation (BV) measures for serum thyrotropin (TSH).

Materials and Methods:
Blood
samples were collected from eight volunteers (four women, four men; ages
ranging between 20 to 35) weekly throughout five weeks. Serum TSH level was
measured on Architect ci8200 immunoassay system and BV estimates were obtained
using nested ANOVA test according to the method of Fraser.

 Results:
Calculated analytical variation (CV_A), within-subject BV (CV_I),
between-subject BV (CV_G), index of individuality (II) and reference
change value (RCV) for serum TSH were 5.4%, 26.2%, 26.9%, 0.99 and 74.2%,
respectively. Desirable performance goals for imprecision,
bias and total allowable error (TE_A) were <13.1% , <6.7% and <28.3% respectively.

Conclusion: When we compared our results with the results from BV database (CV_I=%19.3
and CV_G=%24.6) for serum TSH we found out higher CV_I and CV_G
values. Calculated low II meaning
marked individuality indicates that population-based reference values are less
useful for the evaluation of results while monitoring serum TSH.

Keywords

TSH, biological variation, intra-individual variation, inter-individual variation, referance change value

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