Minimum numbers of fresh whole blood and plasma samples from patients and healthy subjects for ISI calibration of CoaguChek and RapidPointCoag monitors

Leon Poller; Michelle Keown; Nikhil Chauhan; Anton M H P Van den Besselaar; Armando Tripodi; Jorgen Jespersen; Caroline Shiach

doi:10.1309/M1FE-DDVX-2V81-K5MP

Minimum numbers of fresh whole blood and plasma samples from patients and healthy subjects for ISI calibration of CoaguChek and RapidPointCoag monitors

Leon Poller, Michelle Keown, Nikhil Chauhan, Anton M H P Van den Besselaar, Armando Tripodi, Jorgen Jespersen, Caroline Shiach

Research output: Contribution to journal › Article › peer-review

Abstract

The international sensitivity index (ISI) calibration of point-of-care-test (POCT) prothrombin time (PT) whole blood monitors is complex, requiring manual PT testing of 60 patients' and 20 healthy subjects' plasma samples. The possibility of reducing these numbers was studied by a Monte Carlo Bootstrap study for 2 POCT PT systems. For reduced sample numbers, this consisted of 50, 000 calibrations using whole blood and plasma samples tested on the monitors with manual PT testing of plasma samples from the same blood donations. There was little effect on mean ISI by reduction of sample numbers to a total of 7, but there was progressively less certainty regarding the reliability of the calibration. Precision of the calibrations and international normalized ratio deviation were not affected markedly by reducing numbers to half. As ISI calibration with the 2 POCT systems was less precise than conventional manual testing, for maximum confidence, reduction of numbers is not advised.

Original language	English
Pages (from-to)	892-899
Number of pages	7
Journal	American journal of clinical pathology
Volume	117
Issue number	6
DOIs	https://doi.org/10.1309/M1FE-DDVX-2V81-K5MP
Publication status	Published - 2002

Keywords

Fresh plasma
INR
International normalized ratio
International sensitivity index
ISI calibration
Minimum numbers
POCT PT monitors
Point-of-care testing
Prothrombin time
PT
Whole blood

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10.1309/M1FE-DDVX-2V81-K5MP

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Poller, L., Keown, M., Chauhan, N., Van den Besselaar, A. M. H. P., Tripodi, A., Jespersen, J., & Shiach, C. (2002). Minimum numbers of fresh whole blood and plasma samples from patients and healthy subjects for ISI calibration of CoaguChek and RapidPointCoag monitors. American journal of clinical pathology, 117(6), 892-899. https://doi.org/10.1309/M1FE-DDVX-2V81-K5MP

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title = "Minimum numbers of fresh whole blood and plasma samples from patients and healthy subjects for ISI calibration of CoaguChek and RapidPointCoag monitors",

abstract = "The international sensitivity index (ISI) calibration of point-of-care-test (POCT) prothrombin time (PT) whole blood monitors is complex, requiring manual PT testing of 60 patients' and 20 healthy subjects' plasma samples. The possibility of reducing these numbers was studied by a Monte Carlo Bootstrap study for 2 POCT PT systems. For reduced sample numbers, this consisted of 50, 000 calibrations using whole blood and plasma samples tested on the monitors with manual PT testing of plasma samples from the same blood donations. There was little effect on mean ISI by reduction of sample numbers to a total of 7, but there was progressively less certainty regarding the reliability of the calibration. Precision of the calibrations and international normalized ratio deviation were not affected markedly by reducing numbers to half. As ISI calibration with the 2 POCT systems was less precise than conventional manual testing, for maximum confidence, reduction of numbers is not advised.",

keywords = "Fresh plasma, INR, International normalized ratio, International sensitivity index, ISI calibration, Minimum numbers, POCT PT monitors, Point-of-care testing, Prothrombin time, PT, Whole blood",

author = "Leon Poller and Michelle Keown and Nikhil Chauhan and {Van den Besselaar}, {Anton M H P} and Armando Tripodi and Jorgen Jespersen and Caroline Shiach",

year = "2002",

doi = "10.1309/M1FE-DDVX-2V81-K5MP",

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T1 - Minimum numbers of fresh whole blood and plasma samples from patients and healthy subjects for ISI calibration of CoaguChek and RapidPointCoag monitors

AU - Poller, Leon

AU - Keown, Michelle

AU - Chauhan, Nikhil

AU - Van den Besselaar, Anton M H P

AU - Tripodi, Armando

AU - Jespersen, Jorgen

AU - Shiach, Caroline

PY - 2002

Y1 - 2002

N2 - The international sensitivity index (ISI) calibration of point-of-care-test (POCT) prothrombin time (PT) whole blood monitors is complex, requiring manual PT testing of 60 patients' and 20 healthy subjects' plasma samples. The possibility of reducing these numbers was studied by a Monte Carlo Bootstrap study for 2 POCT PT systems. For reduced sample numbers, this consisted of 50, 000 calibrations using whole blood and plasma samples tested on the monitors with manual PT testing of plasma samples from the same blood donations. There was little effect on mean ISI by reduction of sample numbers to a total of 7, but there was progressively less certainty regarding the reliability of the calibration. Precision of the calibrations and international normalized ratio deviation were not affected markedly by reducing numbers to half. As ISI calibration with the 2 POCT systems was less precise than conventional manual testing, for maximum confidence, reduction of numbers is not advised.

AB - The international sensitivity index (ISI) calibration of point-of-care-test (POCT) prothrombin time (PT) whole blood monitors is complex, requiring manual PT testing of 60 patients' and 20 healthy subjects' plasma samples. The possibility of reducing these numbers was studied by a Monte Carlo Bootstrap study for 2 POCT PT systems. For reduced sample numbers, this consisted of 50, 000 calibrations using whole blood and plasma samples tested on the monitors with manual PT testing of plasma samples from the same blood donations. There was little effect on mean ISI by reduction of sample numbers to a total of 7, but there was progressively less certainty regarding the reliability of the calibration. Precision of the calibrations and international normalized ratio deviation were not affected markedly by reducing numbers to half. As ISI calibration with the 2 POCT systems was less precise than conventional manual testing, for maximum confidence, reduction of numbers is not advised.

KW - Fresh plasma

KW - INR

KW - International normalized ratio

KW - International sensitivity index

KW - ISI calibration

KW - Minimum numbers

KW - POCT PT monitors

KW - Point-of-care testing

KW - Prothrombin time

KW - PT

KW - Whole blood

U2 - 10.1309/M1FE-DDVX-2V81-K5MP

DO - 10.1309/M1FE-DDVX-2V81-K5MP

M3 - Article

C2 - 12047140

SN - 0002-9173

VL - 117

SP - 892

EP - 899

JO - American journal of clinical pathology

JF - American journal of clinical pathology

IS - 6

ER -

Minimum numbers of fresh whole blood and plasma samples from patients and healthy subjects for ISI calibration of CoaguChek and RapidPointCoag monitors

Abstract

Keywords

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