Performance evaluation of coaguchek pro II in comparison with coaguchek XS plus and sta-r Max using a sta-neoplastine CI plus.

INTRODUCTION: We evaluated the analytical performance of CoaguChek Pro II (Roche Diagnostics GmbH, Mannheim, Germany), a new point-of-care device measuring the international normalized ratio (INR) values, in comparison with CoaguChek XS Plus (Roche Diagnostics GmbH) and STA-R Max using STA-Neoplastine CI Plus (Diagnostica Stago SAS, Asnières-sur-Seine, France). METHODS: The precision of Pro II was analyzed, according to the Clinical and Laboratory Standards Institute guidelines (CLSI POCT14-A2 and EP15-A3). In 105 clinical samples, the Pro II INR values were compared with those of XS Plus and STA-R Max using STA-Neoplastine CI Plus (CLSI EP09-A3 and EP35). We also compared the Pro II INR values between capillary blood (CB) and venous blood (VB; CLSI EP35). RESULTS: The precision of Pro II was acceptable (within-run and between-run CV%: 2.71% and 3.28% at normal level; 1.52% and 4.47% at abnormal level, respectively). The Pro II INR values showed very high correlation and almost perfect agreement with those of XS Plus and STA-R Max using STA-Neoplastine CI Plus (r = .97 and κ = .94; r = .95 and κ = .91). The mean difference between Pro II and STA-R Max using STA-Neoplastine CI Plus increased as INR values increased, with 60% of samples showing differences >0.5 in the supratherapeutic range. The Pro II INR values showed very high correlation between CB and VB (r = .98). CONCLUSION: Pro II INR values are accurate and reliable using both CB and VB; however, they should be confirmed by laboratory analyzers in the supratherapeutic range.

Evaluation of a new thromboplastin reagent STA-NeoPTimal on a STA R Max analyzer for the measurement of prothrombin time, international normalized ratio and extrinsic factor levels.

INTRODUCTION: We aimed at evaluating the performance of a new prothrombin time (PT) reagent (STA-NeoPTimal) with two other PT reagents (STA-Neoplastine R and STA-Neoplastine CI Plus) and the reference PT reagent used in our laboratory (ReadiPlasTin). METHODS: Evaluation consisted in intra- and interassay precision assessment, determination of sensitivity to unfractionated heparin (UFH) or enoxaparin in spiked samples and to direct oral anticoagulants (DOACs) in patients (n = 43). Method comparison of the 4 PT reagents, factor II, V, VII and X assays was tested on normal (n = 20) and abnormal samples: VKA (n = 47), preoperative (n = 23), liver failure (n = 12) and burned patients (n = 37). RESULTS: Analytical performance met manufacturers' criteria for all reagents. All PT reagents gave correlation coefficients >0.8 and even >0.9 in many situations. In some VKA samples, differences ≥ 0.5 INR units were found in samples within and above therapeutic ranges. For burned patients, PT correlations were good but with some minimal bias (<5.0%) while factor assays gave very consistent results (R > .8 and mainly >0.9). As expected, poor responsiveness of the PT to DOAC concentrations was observed with all four assays. CONCLUSION: The STA-NeoPTimal showed comparable performance to ReadiPlasTin, making it suitable for VKA control, detection of factors II, V, VII, X deficiency and assessment of liver disease coagulopathy. However, for patients receiving VKA, some significant differences were observed. We confirmed the inability of the PT assay to detect residual DOAC concentrations. Finally, burned patients results showed that recombinant thromboplastins were less sensitive to factor deficiencies in comparison to extraction thromboplastins.

Estudio comparativo de equipos INR capilar "point of care" versus INR venoso, en pacientes en tratamiento con antagonistas de vitamina K / Comparison of point of care capillary international normalized ratio (INR) with INR measured in venous samples

Background: INR is used to monitor the treatment with vitamin K antagonists. A strategy to reduce waiting times for sampling is to measure INR in a capillary sample using a portable point of care (POC) type coagulometer. Aim: To evaluate the correlation of CoaguChek Pro II™, Xprecia™ and microINR™ with venous INR measured at the clinical laboratory and their ease of use. Materials and Methods: Patients provided capillary and venous blood samples for parallel tests comparing Xprecia™ Stride with CoaguChek Pro II™ and with venous INR, microINR™ with CoaguChek Pro IITM and with venous INR. The devices' ease of use was assessed surveying the sampling staff. Results: The three tested devices had good correlation coefficients with venous INR: CoaguChek Pro IITM 0.953 and 0.962; Xprecia™ of 0.912 and microINR™ of 0.932. The correlation coefficient of Xprecia™ with CoaguChek Pro IITM was 0.937 and microINR™ with CoaguChek Pro IITM was 0.976. Conclusions: CoaguChek Pro IITM, Xprecia™ and microINR™ results had a good correlation coefficient with INR measured at the laboratory. Our results indicate that, in the hands of trained users, POC-type coagulometers are reliable and acceptable for routine use in anticoagulant treatment control.

Analytical performance of a point-of-care device in monitoring patients on oral anticoagulation with vitamin K antagonists.

BACKGROUND: [Please check the following sentence for clarity: "Point-of-care devices measuring international normalized ratio have clinical appeal, reports of 'off-label' in-hospital/primary care use report improved time to intervention/dose adjustment."]Point-of-care devices measuring international normalized ratio have clinical appeal, reports of 'off-label' in-hospital/primary care use report improved time to intervention/dose adjustment. We evaluated the accuracy and precision of a device for such multiple patient use compared to a reference laboratory. METHODS: The point-of-care international normalized ratio result of patients on oral anticoagulation at the Vascular Surgery clinic was compared to the reference to check for statistical and clinical correlation. This was a prospective case-control study design with sample size calculated for sensitivity of 87.5%, precision 5% and desired confidence level 95%. RESULTS: There were 168 patients tested; 55% were male, the mean age was 45.4. Sixty per cent were in the target international normalized ratio range. Tests were done for statistical and clinical correlation. The international normalized ratio range using the point-of-care device was 0.8-7.5 (reference lab 0.8-10), mean international normalized ratio was 2.22 ± 1.6 (point-of-care device) compared to 2.46 ± 1.3 (reference lab). The mean absolute difference was 0.79 ± 0.92 and the mean relative difference was 8.1% ± 1.03. Data was analysed using a Bland-Altman plot yielding a mean of 0.738 (standard deviation 0.92). Concordance between the tests was 75% with r2 = 0.52 on linear regression. Using an error grid plot, excellent clinical correlation was seen in 63.8%. In 5.4% major corrective action was needed but potentially missed if relying on the point-of-care device. CONCLUSION: The accuracy and precision of this point-of-care device is moderate. It may have potential utility only where access to a reference lab is difficult.

Reliability of a point-of-care device for international normalized ratio testing during the three surgical phases of orthotopic liver transplantation: a retrospective observational study.

PURPOSE: To investigate the reliability of a point-of-care device, the HEMOCHRON(®) Jr. Signature, for measuring the international normalized ratio (INR) during the three surgical phases of liver transplantation. METHODS: A retrospective review was performed on patients undergoing liver transplantation during July to December 2013. Thirty-one patients who had simultaneous laboratory and point-of-care INR readings from each phase of liver transplant surgery (paleohepatic, anhepatic, and neohepatic) were eligible for inclusion. Bland-Altman analysis, Spearman's rank correlation, and four quadrant plots were used to compare INR results from the point-of-care device (pocINR) with those from the laboratory (labINR). RESULTS: Based on the Bland-Altman analysis, mean biases (95% prediction interval) were 0.10 (0.03 to 0.17), 0.19 (0.12 to 0.27), and 0.21 (0.01 to 0.43) for the paleohepatic, anhepatic, and neohepatic phases, respectively. The pocINR device showed a systematic underestimation of the labINR. The Spearman's rank correlation coefficients (95% confidence interval [CI]) were: Ρ = 0.90 (95% CI 0.80 to 0.95); Ρ = 0.92 (95% CI 0.71 to 0.93); and Ρ = 0.71 (95% CI 0.46 to 0.85), respectively. Direction-of-change analysis between the paleohepatic to anhepatic and the anhepatic to neohepatic phases showed strong concordance of 84% and, also considering the small bias between the measurements, supports the use of the pocINR device in the clinical management of liver transplant surgery. CONCLUSION: Point-of-care INR was accurate prior to hepatic reperfusion, but reliability decreased in the neohepatic phase.

Security and cost comparison of INR self-testing and conventional hospital INR testing in patients with mechanical heart valve replacement.

BACKGROUND: International normalized ratio (INR) self-testing can improve the management of anticoagulation therapy with warfarin for the patients following mechanical heart valve replacement. Several reviews and studies have demonstrated self-management as an option to improve patient's outcome considerably after mechanical heart valve replacement. We sought to analyze the security, economy and discuss the prospect of self-testing of anticoagulation therapy in patients following mechanical heart valve replacement in China, and evaluate the accuracy and stability of CoaguChek XS portable INR-testing device. METHODS: This was a prospective self-controlled clinical study conducted with 526 patients receiving oral warfarin anticoagulation therapy after mechanical heart valve replacement in the period of Mar.1, 2012 - Nov.1, 2012 in Cardiovascular Surgery Department of West China Hospital of Sichuan University. The same patient performed INR testing with CoaguChek XS portable coagulometer (group1) and central lab (group 2) in parallel. The follow-up time was 6 months. Meanwhile, a questionnaire was handed out to survey the expenses required for the re-examination visits to the hospital, time, and anticoagulation complications. RESULTS: No severe anticoagulation complications occurred in all the patients. No significant difference of the INR results were observed between group 1 and group 2, they showed significant relevance, r = 0.953(p < 0.05). Compared with the conventional method of INR testing in hospital, the portable coagulometer is convenient, quick and less traumatic. Self-testing of anticoagulation therapy reduced the cost and the time required for re-examination. CONCLUSIONS: Results of CoaguChek XS monitor are precise and have a good consistency and stability as compared with traditional laboratory testing. For the patients receiving anticoagulation therapy after mechanical heart valve replacement, the self-testing of anticoagulation therapy with portable coagulometer is a safe choice, and it has a promising future application in China.

Comparison of the CoaguChek XS handheld coagulation analyzer and conventional laboratory methods measuring international normalised ratio (INR) values during the time to therapeutic range after mechanical valve surgery.

AIM: To compare the international normalised ratio (INR) value of patients evaluated using the CoaguChek XS versus conventional laboratory methods, in the period after open-heart surgery for mechanical valve replacement until a therapeutic range is achieved using vitamin K antagonists (VKA) together with low molecular weight heparin (LMWH). METHODS: One hundred and five patients undergoing open-heart surgery for mechanical valve replacement were enrolled. Blood samples were collected from patients before surgery, and on the second and fifth postoperative days, simultaneously for both the point of care device and conventional laboratory techniques. Patients were administered VKA together with LMWH at therapeutic doses (enoxaparin 100 IU/kg twice daily) subcutaneously, until an effective range was achieved on approximately the fifth day after surgery. RESULTS: The mean INR values using the CoaguChek XS preoperatively and on the second and fifth days postoperatively were 1.20 (SD ± 0.09), 1.82 (SD ± 0.45), and 2.55 (SD ± 0.55), respectively. Corresponding results obtained using conventional laboratory techniques were 1.18 (SD ± 0.1), 1.81 (SD ± 0.43), and 2.51 (SD ± 0.58). The correlation coefficient was r = 0.77 preoperatively, r = 0.981 on postoperative day 2, and r = 0.983 on postoperative day 5. DISCUSSION: Results using the CoaguChek XS Handheld Coagulation Analyzer correlated strongly with conventional laboratory methods, in the bridging period between open-heart surgery for mechanical valve replacement and the achievement of a therapeutic range on warfarin and LMWH.

Use of INR calibrator plasmas in the routine coagulation laboratory: a study of two thrombolastin reagents.

INR values may be either calculated with the ISI values supplied by thromboplastin manufacturers or are directly extrapolated from certified INR calibrator plasmas. We tested the principle of local INR calibration using INR calibrator plasmas (PT-Multi Calibrator, Siemens), two thromboplastin reagents (Neoplastin Plus, rabbit brain, Stago, coagulometer-specific ISI 1.31, and Innovin, recombinant human tissue factor, Siemens) and the same coagulometer (STA-R, Stago) in 100 patients on warfarin. Using a ISI value of 0.77 with Tomenson correction for Innovin (correction factor=1.09), INR values of patients were similar with the two reagents, with a bias of 0.03 INR units and no significant regression of the difference over the average INR by method comparison analysis. With the INR calibrator plasmas, INR values with Neoplastin Plus were lower than Innovin values with an average bias of 0.39 INR units and a significant regression of the difference over the average INR (r=-0.91). Significant bias (0.16 INR units, p<0.00001) and regression (r=-0.77) was also observed by comparison of Neoplastin Plus INRs with Innovin calibrated INRs. Based on a therapeutic INR interval of 2.0 to 3.5, discordance in warfarin dosing was approximately 3 times higher with INR calibration (27% vs 11%). Because of non commutability with fresh plasma samples, local INR calibration with lyophilized calibrator plasmas may not be valid for some reagent-instrument combinations.

Applicability of a compact PT-INR measuring device CoaguChek XS to perioperative management.

OBJECTIVE: In perioperative management, prothrombin time (PT) expressed as the international normalized ratio (INR) is an important preoperative test to assess bleeding risk. It is also used to assess the effect of discontinuing anticoagulant therapy, to determine whether to treat patients with vitamin K or fresh frozen plasma, and to decide whether a deep nerve block (e.g., epidural anesthesia) is needed. Compared with other devices used to measure prothrombin time, the CoaguChek XS is a smaller, lighter and more convenient-to-use PT-INR monitoring system that requires a smaller venous, skin puncture or arterial blood sample than other systems. In a surgical setting, it is often more convenient to collect arterial blood. However, the applicability of arterial blood PT-INR values has not been verified. METHODS: We evaluated the usefulness of the CoaguChek XS in anesthetic management by comparing PT-INR values for arterial blood with those of venous blood in 50 patients who were scheduled for elective surgery under general anesthesia. RESULTS: Arterial PT-INR values were well correlated with venous PT-INR values (r2 = 0.9239; regression line y = 0.9537x + 0.0505). CONCLUSION: These results indicate that the CoaguChek XS system can provide arterial PT-INR values and should be available in operating and emergency rooms.

Determination of an international sensitivity index of thromboplastin reagents using a WHO thromboplastin as calibrator for plasma spiked with rivaroxaban.

Rivaroxaban and other direct factor Xa inhibitors are used at fixed doses without drug monitoring and dose adjustment. Patients may require determination of the anticoagulant effect during treatment. The aim of this study was to develop a method to reduce the differences between thromboplastin reagents and coagulation analysers for determination of the anticoagulant effect of rivaroxaban in human plasma. Purity of rivaroxaban extracted from commercially available drug was confirmed by mass spectrometry, elemental analysis and 1H-NMR spectroscopy. Coagulation times of pooled human plasma spiked with 50-900  ng/ml rivaroxaban were analysed. Thromboplastin reagents, WHO RBT/90, Innovin, RecombiPlasTin 2G, STA Neoplastin Plus, Technoclot PT Plus and Thromborel S, the manual Kolle-Hook method and the KC10 analyser were used. An international sensitivity index (ISI) was determined for each reagent and coagulation method using the RBT/90 thromboplastin reagent as reference. The orthogonal, used for the determination of the ISI of coumarin plasmas, and ordinary regression analyses were compared. The results showed than increasing concentrations of rivaroxaban prolonged coagulation values of all thromboplastin assays linearly (r (2)= 0.96 and r(2) = 0.99, respectively). The coefficient of variation between the slopes of the dilution curves and the ratios of the thromboplastin reagents were reduced using the international normalized ratio (INR) and ISI calculated for rivaroxaban. The ISIs of the thromboplastin reagents ranged from 0.73 to 1.67 as compared with the WHO reagent using the manual technique. The coefficient of variations between the thromboplastin reagents comparing the orthogonal and the ordinary regression analysis were 6.8 versus 3.7% (Kolle-Hook method, P = 0.0011) and 8.5 versus 4.8% (KC10 method, P < 0.0001). Using ISI for vitamin-K antagonist and rivaroxaban, the INRs for the rivaroxaban-containing samples were significantly different for one of five commercial thromboplastin reagents. In conclusion, the determination of an ISI for rivaroxaban using a WHO thromboplastin reagent is required for commercial thromboplastin reagents. The manual Kolle-Hook method and an ordinary linear regression analysis should be adopted.

Potential inaccuracy of point-of-care INR in dabigatran-treated patients.

OBJECTIVE: To report 2 cases in which point-of-care international normalized ratios (INRs) in dabigatran-treated patients were inaccurate. CASE SUMMARY: A 59-year-old woman with paroxysmal atrial fibrillation was started on warfarin. After 3 days, warfarin was discontinued, and the decision was made to switch to dabigatran 150 mg twice a day, which was started 2 days after the warfarin was discontinued. As treatment was being converted from warfarin to dabigatran therapy, the woman's primary care physician referred her to our anticoagulation clinic, where her point-of-care INR was 7.2. A laboratory INR performed approximately 30 minutes later was 1.7. Several repeat point-of-care INRs were elevated and discordant with the laboratory INRs. A second patient, a 52-year-old man, was started on dabigatran after an ablation procedure, as a bridge to warfarin. Approximately 16 hours after a single dose of dabigatran etexilate 150 mg, the point-of-care INR was 1.6. DISCUSSION: Dabigatran etexilate is an oral direct thrombin inhibitor that is approved for use in thromboprophylaxis of atrial fibrillation and deep vein thrombosis. Dabigatran's predictable pharmacokinetic profile allows for a fixed-dose regimen without the need for coagulation monitoring. In certain clinical situations (eg, switching treatment between dabigatran and warfarin), INR testing is performed as part of routine clinical care. During the development program for dabigatran, laboratory testing of INR was performed, with INRs at therapeutic concentrations of dabigatran ranging from 1.1 to 1.7. Supratherapeutic concentrations of dabigatran elevated the INR to slightly higher levels, between 1.7 and 2.4. Even at extremely high dabigatran concentrations, the INR was generally in the range of 2.3-3.5. CONCLUSIONS: We advocate laboratory INR testing with simultaneous assessment of the activated partial thromboplastin time in patients who are receiving or who have recently received dabigatran. A prospective evaluation assessing the accuracy of the commonly used point-of-care INR devices in patients receiving dabigatran would confirm our findings with respect to this device and determine whether our findings extend to other commonly used devices.

Portable INR analysis prior to dental procedures: technique instruction outcomes for senior dental students.

OBJECTIVES: This study aimed to teach dental students to use an INRatio® (HemoSense) device, to apply the results to patients, and to evaluate the outcomes. DESIGN: This was a retrospective convenience data study that used student surveys. SETTING: The research was conducted at The Ohio State University College of Dentistry Geriatric Dental Program in Columbus, Ohio. PARTICIPANTS: A total of 105 senior dental students participated in an INRatio training program. METHODS: The instructions involved the following: 1) a table showing INRatio protocol and dental procedures versus international normalized ratio (INR) guidelines; 2) an online technique training course, 3) a trial INRatio test on another senior dental student; and 4) INRatio for a dental patient. MAIN OUTCOMES: The clinical outcomes including INR values were a retrospective convenience data study. Instructional outcomes were obtained from student surveys. RESULTS: A total of 79% of students indicated they would use portable INR testing in their future practices; however, 73% of students had difficulty obtaining an adequate blood sample. All patient surgical procedures were completed successfully without serious complications. CONCLUSIONS: This study indicates the INRatio analysis can be included in dental student training, providing safe, efficient, and successful patient care. Difficulty obtaining blood samples suggests the need for extra training, additional clinical experience, and INR devices requiring smaller blood samples.

An error in the CoaguChek S device results in prosthetic heart valve thrombosis.

The CoaguChek S device offers patients on oral anticoagulant treatment, a simple and fast method of direct monitoring of their international normalized ratio (INR). It is comparable with the glucose monitoring system, a fingerprick for a drop of capillary blood and some minutes to get the INR result for further anticoagulation monitoring. We present a case of tricuspid prosthetic valve thrombosis due to inadequate anticoagulation because of an error in the point-of-care device.

Correlation of point-of-care International Normalized Ratio to laboratory International Normalized Ratio in hemodialysis patients taking warfarin.

BACKGROUND AND OBJECTIVES: To determine whether point-of-care (POC) International Normalized Ratio (INR) test results correlate with plasma INR measures in intermittent hemodialysis (IHD) patients on warfarin. Anemia is thought to reduce the accuracy of POC INR assay results. Whether POC INR testing could be implemented for hemodialysis patients on chronic warfarin, who are often anemic despite hematopoietic therapy, has not been established. DESIGN, SETTING, PARTICIPANTS, & MEASUREMENTS: Thirty-seven chronic hemodialysis patients on warfarin contributed sets of three consecutive blood samples for INR comparison immediately before hemodialysis: one finger stick, two from hemodialysis access (arteriovenous graft, fistula, or catheter). POC INR testing was performed using CoaguChek S device. Anemia was defined as hematocrit < 32%. RESULTS: Pairwise comparison and correlation of 258 INR results showed high correlation for POC versus laboratory INR (r = 0.94; P < 0.001). Of these, 16 (6%) differed by >0.6 INR units, four (1.6%) differed by >0.8 INR units, and one differed by >1.0 INR units. Resulting pairwise correlation analyses between samples were: for anemic patients (0.96; P < 0.001), nonanemic patients (0.93; P < 0.001), and for those obtained from arteriovenous grafts (0.94; P < 0.001). POC INR samples from dialysis catheters correlated poorly with laboratory INR results. CONCLUSIONS: POC INR correlates well with plasma INR measures in IHD patients requiring chronic warfarin, and anemia did not influence this reliability. Blood sampling from finger stick or arteriovenous graft or fistula showed excellent correlation with laboratory INR, whereas sampling from dialysis catheters was unsatisfactory, likely from heparin contamination.

In-patient international normalized ratio self-testing instruction after mechanical heart valve implantation.

BACKGROUND: Patient self-testing of the international normalized ratio (INR) has been shown to improve management of anticoagulation with warfarin and reduce risks of thromboembolism and bleeding. Self-testing instruction usually begins several weeks after hospital discharge. We evaluated the feasibility of in-hospital INR self-testing instruction in patients recovering from valve replacement. METHODS: We instituted an education program on a self-testing device before hospital discharge in 50 adult patients (median age, 54 years; 66% men) undergoing cardiac valve replacement with mechanical prostheses. Patients were monitored for 1 month to assess their ability to self-test and the accuracy of the INR measurements. RESULTS: Self-testing instruction began on postoperative day 4 (range, 1 to 8 days). Each patient had an average of 3.5 teaching sessions; each session lasted approximately 20 minutes. One month after discharge, all patients (98%) but 1 were able to self-test. No patient required interval instruction. One bleeding episode occurred in a patient whose INR exceeded the therapeutic range. Once warfarin doses were stabilized, 5 patients had subtherapeutic INR values on self-testing. The mean INR test result obtained from the coagulometer correlated well with values obtained by laboratory determination (r = 0.79). CONCLUSIONS: This evaluation of an in-hospital education program demonstrates that patients are able to learn INR self-testing and that most will continue to use the method without the need for interval instruction. Improved anticoagulation management by early introduction of INR self-testing should reduce thromboembolic and hemorrhagic complications after valve replacement.

Whole blood international normalization ratio measurements in children using near-patient monitors.

PURPOSE: To report a comparison of international normalization ratio (INR) measurements on four near-patient (point-of-care or bedside) whole blood INR monitors in children. PATIENTS AND METHODS: The INR results from 19 ambulatory pediatric subjects (30 hospital visits) receiving warfarin sodium were analyzed on four near-patient monitors and compared with plasma INR measurements on the laboratory CA-1000 Analyze. The instruments evaluated were CoaguChek, Hemochron Jr. Signature, ProTime Microcoagulation System, and RapidpointCoag. RESULTS: The INR measurements ranged from 1.05 to 5.25. Over the entire INR range, the near-patient instrument with the least bias relative to the CA-1000 was the RapidpointCoag (r(2) = 0.923). The correlations (r(2)) of the CoaguCheck, Hemochron Jr., and ProTime were 0.877, 0.834, and 0.885, respectively. Precision studies involved repeated analysis of one nonmedicated adult (mean CA-1000 INR = 0.908) and one adult receiving oral anticoagulation therapy (mean CA-1000 INR = 2.42). The coefficient of variation on the near-patient monitors for both adult volunteers ranged from 4.9% to 22.3%. Bilirubin levels up to 20 mg/dL did not interfere in any of the methods. CONCLUSIONS: Near-patient testing whole blood INR monitors offer acceptably accurate and precise measurements. Values obtained on near-patient monitors may vary considerably from the reference method, and data obtained should serve as a supplement to, but not a replacement for, routine clinical laboratory measurements.

The clinical relevance of the citrate effect on International Normalized Ratio determinations depends on the reagent and instrument combination used.

Multiple studies have shown that the two different citrate concentrations in common use as the anticoagulant in blood collection for haemostasis assays can affect the results obtained with the prothrombin time assay. It is clear from the literature that there is considerable variability in the results obtained using different instrument-reagents combinations, but the clinical relevance of these differences is unclear. Most of the studies have used an optical system for end-point detection. This study reports on the citrate sensitivity using mechanical end-point detection. Using two different reagents, one previously shown to be citrate sensitive on optical systems (Neoplastin CI plus) and a citrate-insensitive reagent (Neoplastin CI), we demonstrate that the effect of using different citrate concentrations (0.105 or 0.129 mol/l) has statistically significant but clinically irrelevant effects on the International Normalized Ratio using a mechanical instrument (STA)-reagent combination (mean percentage difference in results, 1.9 and 3.8% respectively). This demonstrates that the citrate effect is both instrument type and reagent dependent. Every reagent and instrument combination needs to be tested to see whether any citrate effect exists. In a secondary study, it was shown that the international reference rabbit thromboplastin (CRM 149(s)) was not citrate-concentration sensitive.