Thyroid for thyroid function test reference intervals during pregnancy using the Vitros 5600.

E Haworth; C Chang; T Yen; A Chiriano; S Matthews

Abstract

Introduction

Harmonization of reference intervals (RI) for thyroid function tests (TFT) is restricted by assay variation, but the derivation of ‘method-specific’ TFT RI has been recommended by professional working parties. This study aims to develop evidence-based, Ortho Clinical Diagnostics (OCD) RI for TSH, fT4 and fT3 in pregnancy, since our laboratory is one of few to report TFT results for this method group in the RCPA QAP Endocrine Program.

Methods

We compared OCD (Vitros 5600) TSH, fT4 and fT3 in pregnant patients with results from Abbott Architect Systems, a frequently used method, to define method-specific variation. The Abbott Architect correlation data and published RI review ‘anchored’ the patient (n=4405) derived, trimester specific RI for OCD TSH, fT4 and fT3 assays.

Results

OCD and Abbott Architect TSH results (0–8 mIU/L) correlated well (r²=0.993), with insignificant bias (y=0.956x – 0.079). Patient data and literature analysis supported 1^st trimester (0.09–2.82 mIU/L), 2^nd trimester (0.20–2.79 mIU/L) and 3^rd trimester (0.31–2.90 mIU/L) RI for OCD TSH.

OCD and Abbott Architect fT4 results (6–20 pmol/L) correlated (r²=0.929), but OCD fT4 values <12 pmol/L showed negative bias (y=0.766x + 3.702). Patient data and literature analysis supported 1^st trimester (10.0–25.0 pmol/L), 2^nd trimester (9.0–19.0pmol/L) and ^3rd trimester (8.0–19.6 pmol/L) RI for OCD fT4.

There was poor correlation (r²=0.6141) for OCD and Abbott Architect fT3 values between 2–6 pmol/L. Patient data and literature analysis supported 1^st trimester (3.5–6.2 pmol/L), 2^nd trimester (3.4–5.8pmol/L) and 3^rd trimester (3.3–5.6 pmol/L) RI for OCD fT3.

Conclusion

Abbott Architect correlation data and published TFT RIs ‘anchored’ the review of patient derived, trimester specific RI for OCD TSH, fT4 and fT3. A review of patient data “flagging rates” and clinical consultation confirmed the validity of the derived OCD TSH, fT4 and fT3 RI, prior to implementation.

Original language	English
Article number	P71
Number of pages	1
Journal	Clinical Biochemist Reviews
Volume	36
Issue number	Suppl
Publication status	Published - 2015
Externally published	Yes
Event	Australasian Association of Clinical Biochemists 53rd Annual Scientific Conference - ANZ Stadium, Sydney Olympic Park, Sydney, Australia Duration: 15 Sept 2015 → 17 Sept 2015 Conference number: 53rd

Keywords

thyroid function test
TFT
Pregnancy
gestational
reference intervals

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Cite this

@article{b8b89f64fb664588807a5223a38b187d,

title = "Thyroid for thyroid function test reference intervals during pregnancy using the Vitros 5600.",

abstract = "IntroductionHarmonization of reference intervals (RI) for thyroid function tests (TFT) is restricted by assay variation, but the derivation of {\textquoteleft}method-specific{\textquoteright} TFT RI has been recommended by professional working parties. This study aims to develop evidence-based, Ortho Clinical Diagnostics (OCD) RI for TSH, fT4 and fT3 in pregnancy, since our laboratory is one of few to report TFT results for this method group in the RCPA QAP Endocrine Program.MethodsWe compared OCD (Vitros 5600) TSH, fT4 and fT3 in pregnant patients with results from Abbott Architect Systems, a frequently used method, to define method-specific variation. The Abbott Architect correlation data and published RI review {\textquoteleft}anchored{\textquoteright} the patient (n=4405) derived, trimester specific RI for OCD TSH, fT4 and fT3 assays.ResultsOCD and Abbott Architect TSH results (0–8 mIU/L) correlated well (r2=0.993), with insignificant bias (y=0.956x – 0.079). Patient data and literature analysis supported 1st trimester (0.09–2.82 mIU/L), 2nd trimester (0.20–2.79 mIU/L) and 3rd trimester (0.31–2.90 mIU/L) RI for OCD TSH.OCD and Abbott Architect fT4 results (6–20 pmol/L) correlated (r2=0.929), but OCD fT4 values <12 pmol/L showed negative bias (y=0.766x + 3.702). Patient data and literature analysis supported 1st trimester (10.0–25.0 pmol/L), 2nd trimester (9.0–19.0pmol/L) and 3rd trimester (8.0–19.6 pmol/L) RI for OCD fT4.There was poor correlation (r2=0.6141) for OCD and Abbott Architect fT3 values between 2–6 pmol/L. Patient data and literature analysis supported 1st trimester (3.5–6.2 pmol/L), 2nd trimester (3.4–5.8pmol/L) and 3rd trimester (3.3–5.6 pmol/L) RI for OCD fT3.ConclusionAbbott Architect correlation data and published TFT RIs {\textquoteleft}anchored{\textquoteright} the review of patient derived, trimester specific RI for OCD TSH, fT4 and fT3. A review of patient data “flagging rates” and clinical consultation confirmed the validity of the derived OCD TSH, fT4 and fT3 RI, prior to implementation.",

keywords = "thyroid function test, TFT, Pregnancy, gestational, reference intervals",

author = "E Haworth and C Chang and T Yen and A Chiriano and S Matthews",

year = "2015",

language = "English",

volume = "36",

journal = "Clinical Biochemist Reviews",

issn = "0159-8090",

publisher = "Australasian Association of Clinical Biochemists",

number = "Suppl",

note = "Australasian Association of Clinical Biochemists 53rd Annual Scientific Conference, 53rd AACB ASM ; Conference date: 15-09-2015 Through 17-09-2015",

}

TY - JOUR

T1 - Thyroid for thyroid function test reference intervals during pregnancy using the Vitros 5600.

AU - Haworth, E

AU - Chang, C

AU - Yen, T

AU - Chiriano, A

AU - Matthews, S

N1 - Conference code: 53rd

PY - 2015

Y1 - 2015

N2 - IntroductionHarmonization of reference intervals (RI) for thyroid function tests (TFT) is restricted by assay variation, but the derivation of ‘method-specific’ TFT RI has been recommended by professional working parties. This study aims to develop evidence-based, Ortho Clinical Diagnostics (OCD) RI for TSH, fT4 and fT3 in pregnancy, since our laboratory is one of few to report TFT results for this method group in the RCPA QAP Endocrine Program.MethodsWe compared OCD (Vitros 5600) TSH, fT4 and fT3 in pregnant patients with results from Abbott Architect Systems, a frequently used method, to define method-specific variation. The Abbott Architect correlation data and published RI review ‘anchored’ the patient (n=4405) derived, trimester specific RI for OCD TSH, fT4 and fT3 assays.ResultsOCD and Abbott Architect TSH results (0–8 mIU/L) correlated well (r2=0.993), with insignificant bias (y=0.956x – 0.079). Patient data and literature analysis supported 1st trimester (0.09–2.82 mIU/L), 2nd trimester (0.20–2.79 mIU/L) and 3rd trimester (0.31–2.90 mIU/L) RI for OCD TSH.OCD and Abbott Architect fT4 results (6–20 pmol/L) correlated (r2=0.929), but OCD fT4 values <12 pmol/L showed negative bias (y=0.766x + 3.702). Patient data and literature analysis supported 1st trimester (10.0–25.0 pmol/L), 2nd trimester (9.0–19.0pmol/L) and 3rd trimester (8.0–19.6 pmol/L) RI for OCD fT4.There was poor correlation (r2=0.6141) for OCD and Abbott Architect fT3 values between 2–6 pmol/L. Patient data and literature analysis supported 1st trimester (3.5–6.2 pmol/L), 2nd trimester (3.4–5.8pmol/L) and 3rd trimester (3.3–5.6 pmol/L) RI for OCD fT3.ConclusionAbbott Architect correlation data and published TFT RIs ‘anchored’ the review of patient derived, trimester specific RI for OCD TSH, fT4 and fT3. A review of patient data “flagging rates” and clinical consultation confirmed the validity of the derived OCD TSH, fT4 and fT3 RI, prior to implementation.

AB - IntroductionHarmonization of reference intervals (RI) for thyroid function tests (TFT) is restricted by assay variation, but the derivation of ‘method-specific’ TFT RI has been recommended by professional working parties. This study aims to develop evidence-based, Ortho Clinical Diagnostics (OCD) RI for TSH, fT4 and fT3 in pregnancy, since our laboratory is one of few to report TFT results for this method group in the RCPA QAP Endocrine Program.MethodsWe compared OCD (Vitros 5600) TSH, fT4 and fT3 in pregnant patients with results from Abbott Architect Systems, a frequently used method, to define method-specific variation. The Abbott Architect correlation data and published RI review ‘anchored’ the patient (n=4405) derived, trimester specific RI for OCD TSH, fT4 and fT3 assays.ResultsOCD and Abbott Architect TSH results (0–8 mIU/L) correlated well (r2=0.993), with insignificant bias (y=0.956x – 0.079). Patient data and literature analysis supported 1st trimester (0.09–2.82 mIU/L), 2nd trimester (0.20–2.79 mIU/L) and 3rd trimester (0.31–2.90 mIU/L) RI for OCD TSH.OCD and Abbott Architect fT4 results (6–20 pmol/L) correlated (r2=0.929), but OCD fT4 values <12 pmol/L showed negative bias (y=0.766x + 3.702). Patient data and literature analysis supported 1st trimester (10.0–25.0 pmol/L), 2nd trimester (9.0–19.0pmol/L) and 3rd trimester (8.0–19.6 pmol/L) RI for OCD fT4.There was poor correlation (r2=0.6141) for OCD and Abbott Architect fT3 values between 2–6 pmol/L. Patient data and literature analysis supported 1st trimester (3.5–6.2 pmol/L), 2nd trimester (3.4–5.8pmol/L) and 3rd trimester (3.3–5.6 pmol/L) RI for OCD fT3.ConclusionAbbott Architect correlation data and published TFT RIs ‘anchored’ the review of patient derived, trimester specific RI for OCD TSH, fT4 and fT3. A review of patient data “flagging rates” and clinical consultation confirmed the validity of the derived OCD TSH, fT4 and fT3 RI, prior to implementation.

KW - thyroid function test

KW - TFT

KW - Pregnancy

KW - gestational

KW - reference intervals

M3 - Meeting Abstract

SN - 0159-8090

VL - 36

JO - Clinical Biochemist Reviews

JF - Clinical Biochemist Reviews

IS - Suppl

M1 - P71

T2 - Australasian Association of Clinical Biochemists 53rd Annual Scientific Conference

Y2 - 15 September 2015 through 17 September 2015

ER -

Thyroid for thyroid function test reference intervals during pregnancy using the Vitros 5600.

Abstract

Keywords

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