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Verifying reference intervals for coagulation tests by using stored data.

Hale Aral¹, Murat Usta, Ahmet M Cilingirturk

¹Clinical Biochemistry Laboratory, Ministry of Health Istanbul Research and Training Hospital, Istanbul, Turkey. drhalearal@yahoo.com

Scandinavian Journal of Clinical and Laboratory Investigation

|October 25, 2011

Summary

This study verified reference intervals for prothrombin time (PT) and activated partial thromboplastin time (APTT) in pre-operative patients. Age and sex significantly impacted PT and APTT results, necessitating confirmation of established reference ranges.

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Area of Science:

Clinical Chemistry
Hematology
Medical Diagnostics

Background:

Established reference intervals for coagulation tests like prothrombin time (PT) and activated partial thromboplastin time (APTT) are crucial for accurate clinical interpretation.
Variations in these intervals may exist based on demographic factors such as age and sex.
Verifying these reference intervals in specific patient populations ensures diagnostic reliability.

Purpose of the Study:

To validate the existing reference intervals for prothrombin time (PT) and activated partial thromboplastin time (APTT).
To assess the influence of age and sex on PT and APTT measurements in ambulatory pre-operative subjects.
To determine if current reference ranges require adjustment based on demographic data.

Main Methods:

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Retrieved 13,600 PT and 14,083 APTT results from pre-operative ambulatory patients (aged 15-80) from 2008.

Utilized Sysmex® CA-1500 analyzer with Thromborel S and Actin reagents.

Applied Horn's algorithm with Box-Cox transformation to identify extreme values and calculated reference limits as 2.5th and 97.5th percentiles.

Main Results:

Significant age-related differences were observed in both PT (p < 0.0001) and APTT (p < 0.0001) measurements.
A statistically significant difference was found in PT between sexes (p = 0.002).
No significant statistical difference was noted in APTT results between males and females.

Conclusions:

The study identified significant age and sex-related variations in PT and APTT, diverging from standard kit insert values.
Confirmation of findings using direct methods is recommended, particularly for APTT in specific age groups (under 40, over 59) and for sex differences in PT.
Current reference intervals may need re-evaluation for specific demographic subgroups to enhance diagnostic accuracy.