scholarly journals НАЧАЛЬНЫЙ ЭТАП ТЕСТИРОВАНИЯ РАЗРАБАТЫВАЕМОГО АППАРАТА ДЛЯ ОПРЕДЕЛЕНИЯ МЕЖДУНАРОДНОГО НОРМАЛИЗОВАННОГО ОТНОШЕНИЯ

2018 ◽  
Vol 10 (5) ◽  
pp. 46
Author(s):  
Natalya Valeryevna Aksyutina ◽  
Vladimir Abramovich Shulman ◽  
Fedor Georgievich Zograf ◽  
Vasiliy Sergeyevich Mordovsky ◽  
Pavel Sergeevich Marinushkin ◽  
...  
Keyword(s):  
Coaguchek Xs

Протромбиновое время (ПТВ) – это лабораторный показатель, позволяющий оценить внешний путь свертывания крови (активность факторов I, II, V, VII и X). Для стандартизации результатов теста ПТВ введен показатель МНО. МНО = (ПТВ пациента/ПТВ 100%)МИЧ. Набирает популярность контроль МНО с помощью портативных коагулометров. На российском рынке представлены: CoaguChek XS, qLabs Electrometer. Главная проблема − их высокая стоимость и дороговизна в эксплуатации. Российские ученые давно задались вопросом импортозамещения. Однако, в литературе нет информации о тестировании разработок. При разработке экспериментальной модели для измерения МНО и ПТВ, мы руководствовались результатами литературного поиска по наукометрическим базам данных Elibrary, Scopus, PubMed и WoS с учетом предполагаемой стоимости разрабатываемой модели.Цель исследования. Провести начальный этап тестирования экспериментальной модели с сопоставлением полученных результатов с данными сертифицированной лаборатории.Материал и методы. Обследовано 70 пациентов (26 мужчин и 44 женщины), принимающих «Варфарин». Материал для измерения экспериментальной моделью – капиллярная кровь. В качестве тест-системы применяли тест-полоску qLabs® PT-INR Test Strip.Результаты. Разница ПТВ тестируемой модели и результатов сертифицированной лаборатории ± 1–2 секунды. ПТВ Протромбин-калибратора 13 сек. Протромбиновое отношение Протромбин-калибратора 1,0. Пациент №1. ПТВ на тестируемом аппарате 34 сек. МИЧ тробопластина на тест-полоске 1,0. МНО = (34 сек /13 сек × 1,0)1,0 = 2,62. Результат сертифицированной лаборатории: ПТВ 36 сек, МНО 2,86. Пациент №2. ПТВ на тестируемом аппарате 31 сек. МНО = (31 сек/13 сек × 1,0)1,0 = 2,38. Результаты сертифицированной лаборатории: ПТВ 32 сек, МНО 2,48.Вывод. Согласно представленным результатам, полученным в ходе тестирования разработанной портативной модели у пациентов, находящихся на варфаринотерапии, получены сопоставимые результаты ПТВ и МНО сертифицированной лабораторией.

POCT PT INR — Is it adequate for patient care? A comparison of the Roche Coaguchek XS vs. Stago Star vs. Siemens BCS in patients routinely seen in an anticoagulation clinic

2017 ◽  
Vol 472 ◽  
pp. 139-145 ◽  
Author(s):  
Wendy S. Baker ◽  
Kathleen J. Albright ◽  
Megan Berman ◽  
Heidi Spratt ◽  
Peggy A. Mann ◽  
...  
Keyword(s):  
Patient Care ◽  
Anticoagulation Clinic ◽  
Coaguchek Xs

scholarly journals Comparison of Prothrombin Time Derived From CoaguChek XS and Laboratory Test According to Fibrinogen Level

2014 ◽  
Vol 29 (1) ◽  
pp. 28-31 ◽  
Author(s):  
Sue Jung Kim ◽  
Eun Young Lee ◽  
Rojin Park ◽  
Juwon Kim ◽  
Jaewoo Song
Keyword(s):  
Laboratory Test ◽  
Prothrombin Time ◽  
Fibrinogen Level ◽  
Coaguchek Xs

Accuracy of the CoaguChek XS for point-of-care international normalized ratio (INR) measurement in children requiring warfarin

2008 ◽  
Vol 99 (06) ◽  
pp. 1097-1103 ◽  
Author(s):  
Karina Black ◽  
Mary Massicotte ◽  
Michelle Bauman ◽  
Stefan Kuhle ◽  
Susan Howlett-Clyne ◽  
...  
Keyword(s):  
Point Of Care ◽  
Vitamin K Antagonists ◽  
Venous Blood ◽  
International Normalized Ratio ◽  
Test Results ◽  
Standard Laboratory ◽  
Limits Of Agreement ◽  
Time Points ◽  
Coaguchek Xs ◽  
Roche Diagnostics

SummaryPoint-of-care INR (POC INR) meters can provide a safe and effective method for monitoring oral vitamin K antagonists (VKAs) in children. Stollery Children’s Hospital has a large POC INR meter loan program for children requiring oral VKAs. Our protocol requires that POC INR results be compared to the standard laboratory INR for each child on several consecutive tests to ensure accuracy of CoaguChek XS® (Roche Diagnostics, Basel Switzerland) meter. It was the objective of the study to determine the accuracy of the CoaguChek XS by comparing whole blood INR results from the CoaguChek XS to plasma INR results from the standard laboratory in children. POC INR meter validations were performed on plasma samples from two time points from 62 children receiving warfarin by drawing a venous blood sample for laboratory prothrombin (PT)-INR measurements and simultaneous INR determinations using the POC-INR meter. Agreement between CoaguChek XS INR and laboratory INR was assessed using Bland-Altman plots. Bland-Altman's 95% limits of agreement were 0.11 (-0.20; 0.42) and 0.13 (-0.22; 0.48) at the two time points, respectively. In conclusion, the CoaguChek XS meter appraisal generates an accurate and precise INR measure in children when compared to laboratory INR test results.

Stability of CoaguChek XS test strip is not effected by frequency of air exposure

2010 ◽  
Vol 32 (6p1) ◽  
pp. e248-e250
Author(s):  
K. H. Son ◽  
C. B. Ahn ◽  
H. An ◽  
G. Choe ◽  
S. H. Lee ◽  
...  
Keyword(s):  
Test Strip ◽  
Air Exposure ◽  
Coaguchek Xs

scholarly journals Comparison between the conventional method and a portable device for determination of INR

2014 ◽  
Vol 13 (2) ◽  
pp. 88-93 ◽  
Author(s):  
André Camacho Oliveira Araújo ◽  
Rodrigo Borges Domingues ◽  
Bonno van Bellen
Keyword(s):  
Correlation Coefficient ◽  
Conventional Method ◽  
Statistical Significance ◽  
Oral Anticoagulants ◽  
Venous Blood ◽  
Laboratory Method ◽  
Capillary Blood ◽  
Appropriate Treatment ◽  
Two Samples ◽  
Coaguchek Xs

CONTEXT: Anticoagulation with warfarin is considered the appropriate treatment for venous thromboembolism and other thrombotic pathologies. Regular INR control is required for dosage adjustment and therapeutic control. Use of portable monitoring systems optimizes management of these patients. OBJECTIVE: To compare INR measurements taken using the portable Coaguchek XS system in capillary blood with the standard laboratory method using venous blood. METHOD: Fifty-two samples each of venous and capillary blood were collected from nineteen patients on warfarin, who had been admitted to the Hospital da Beneficência Portuguesa de São Paulo, and analyzed using the conventional method and the Coaguchek XS system, respectively. RESULTS: Spearman's correlation coefficient ® for the overall performance of the two methods was 0.978 (p<0.0001; 95%CI 0.961-0.988). The Kappa measure of agreement for all patients was 76.8% (p<0.001; IC: 95% 0.975-0.561). Mean INR according to the Coaguchek XS system underestimated the values provided by the conventional method by -0.01 INR points, with a standard error of 0.342. Results for INR values greater than 3.5 were satisfactory with a correlation coefficient of 0.71, but without statistical significance (p>0.714). CONCLUSIONS: The Coaguchek XS system can be used to monitor prothrombin time in patients on oral anticoagulants, provided INR values greater than 3.5 are confirmed using the conventional laboratory method.

Utility of CoaguChek XS for Monitoring the Prothrombin Time

2008 ◽  
Vol 65 (6) ◽  
pp. 471 ◽  
Author(s):  
Rojin Park ◽  
Yong-Hyun Kim ◽  
Kyung Ock Kwon ◽  
Jongsung Na ◽  
Yong Soon Won ◽  
...  
Keyword(s):  
Prothrombin Time ◽  
Coaguchek Xs

Point-of-care testing and INR within-subject variation in patients receiving a constant dose of vitamin K antagonist

2015 ◽  
Vol 114 (12) ◽  
pp. 1260-1267
Author(s):  
Joseph S. Biedermann ◽  
Marieke J. H. A. Kruip ◽  
A. M. H. P. van den Besselaar
Keyword(s):  
Blood Coagulation ◽  
Vitamin K ◽  
Whole Blood ◽  
Point Of Care ◽  
Vitamin K Antagonists ◽  
Professional Staff ◽  
Self Testing ◽  
Target Intensity ◽  
Constant Dose ◽  
Coaguchek Xs

SummaryMany patients treated with vitamin K antagonists (VKA) determine their INR using point-of-care (POC) whole blood coagulation monitors. The primary aim of the present study was to assess the INR within-subject variation in self-testing patients receiving a constant dose of VKA. The second aim of the study was to derive INR imprecision goals for whole blood coagulation monitors. Analytical performance goals for INR measurement can be derived from the average biological within-subject variation. Fifty-six Thrombosis Centres in the Netherlands were invited to select self-testing patients who were receiving a constant dose of either acenocoumarol or phenprocoumon for at least six consecutive INR measurements. In each patient, the coefficient of variation (CV) of INRs was calculated. One Thrombosis Centre selected regular patients being monitored with a POC device by professional staff. Sixteen Dutch Thrombosis Centres provided results for 322 selected patients, all using the CoaguChek XS. The median within-subject CV in patients receiving acenocoumarol (10.2 %) was significantly higher than the median CV in patients receiving phenprocoumon (8.6 %) (p = 0.001). The median CV in low-target intensity acenocoumarol self-testing patients (10.4 %) was similar to the median CV in regular patients monitored by professional staff (10.2 %). Desirable INR analytical imprecision goals for POC monitoring with CoaguChek XS in patients receiving either low-target intensity acenocoumarol or phenprocoumon were 5.1 % and 4.3 %, respectively. The approximate average value for the imprecision of the CoaguChek XS, i. e. 4 %, is in agreement with these goals.

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