Accuracy assessment of consecutive test strip lots for whole blood INR point-of-care instruments: clarifying the role of frozen plasma pools

2019 ◽  
Vol 57 (9) ◽  
pp. 1349-1357 ◽  
Author(s):  
Antonius M.H.P. van den Besselaar ◽  
Charmane F. Abdoel ◽  
Claudia J.J. van Rijn ◽  
Felix J.M. van der Meer ◽  
Christa M. Cobbaert
Keyword(s):  
Whole Blood ◽  
Accuracy Assessment ◽  
Test Strip ◽  
Positive Trend ◽  
Accuracy Evaluation ◽  
Blood Samples ◽  
Test Strips ◽  
International Standard ◽  
Coaguchek Xs ◽  
Frozen Plasma

Abstract Background In the Netherlands, each new lot of test strips for the CoaguChek XS is validated by a group of collaborating centers. The purpose of this study was to assess the accuracy of the international normalized ratio (INR) measured with consecutive test strip lots and the suitability of frozen plasma pools for accuracy evaluation. Methods Each year, a particular lot of CoaguChek XS test strips is used as reference lot. The reference lots have been validated with the International Standard for thromboplastin rTF/09, yielding a mathematical relationship (R1) between reference lot INR and International Standard INR. New lots are compared to the reference lot using patients’ capillary blood samples, yielding a relationship (R2) between the new lot INR and the reference lot INR. INRs of the blood samples were within the 1.5–4.5 interval. In parallel, three frozen plasmas pools are analyzed with the test strips. The distance of each plasma point to the line of relationship R2 was assessed. Results Fifty-four test strip lots have been evaluated during 3 years (2014–2016). Mean INR differences between test strip lot and International Standard rTF/09 varied between −0.14 and +0.20 (−4% and +8%, respectively). A positive trend with strip lot sequence number was observed (p<0.001). In several cases, the distance of the frozen plasmas to the whole blood relationship (R2) was greater than the critical value for commutability. Conclusions Using whole blood, all evaluated test strip lots met the analytical bias criterion of ±10%. Frozen plasma pools behave differently compared to whole blood and are not suitable for assessing absolute accuracy of new CoaguChek XS test strips.

Point-of-care monitoring of vitamin K-antagonists: validation of CoaguChek XS test strips with International Standard thromboplastin

2012 ◽  
Vol 65 (11) ◽  
pp. 1031-1035 ◽  
Author(s):  
Anton M H P van den Besselaar ◽  
Nathalie C V Péquériaux ◽  
Marij Ebben ◽  
Joke van der Feest ◽  
Kerst de Jong ◽  
...  
Keyword(s):  
The Netherlands ◽  
Vitamin K ◽  
Point Of Care ◽  
Vitamin K Antagonists ◽  
Capillary Blood ◽  
Blood Samples ◽  
Test Strips ◽  
International Standard ◽  
The Mean ◽  
Coaguchek Xs

AimsMany patients treated with vitamin K-antagonists (VKA) use point-of-care (POC) whole blood coagulometers for self-testing. The majority of patients in the Netherlands use one type of POC coagulometer, that is, the CoaguChek XS. Each new lot of test strips for the CoaguChek XS is validated by a group of collaborating thrombosis centres. We assessed the International Normalised Ratio (INR) differences between each of 51 new lots of test strips and the International Standard for thromboplastin rTF/95 or its successor rTF/09.MethodsEach year, a particular lot of CoaguChek XS test strips was used as reference lot. The reference lot was validated by comparison to the International Standard, yielding a relationship between the reference lot INR and International Standard INR. Successive lots of test strips were compared to the reference lot by three centres using 19–29 capillary blood samples obtained from VKA-treated patients. Each patient provided two blood drops from the same finger prick, one for the reference lot strip and one for the new lot.ResultsThe mean INR differences between each lot and the International Standard varied between −8% and +4%. The mean absolute values of the relative differences varied between 2.4% and 8.1%. There were small but clinically unimportant differences in INR between the first and second drop of blood.ConclusionsAccuracy of CoaguChek XS INR determinations can be assessed by a group of collaborating centres using a limited number of capillary blood samples. As the mean INR differences with the International Standard were smaller than 10%, the lots were approved for use by the Netherlands Thrombosis Services.

scholarly journals A high-throughput microfluidic nanoimmunoassay for detecting anti–SARS-CoV-2 antibodies in serum or ultralow-volume blood samples

2021 ◽  
Vol 118 (18) ◽  
pp. e2025289118
Author(s):  
Zoe Swank ◽  
Grégoire Michielin ◽  
Hon Ming Yip ◽  
Patrick Cohen ◽  
Diego O. Andrey ◽  
...  
Keyword(s):  
Human Serum ◽  
High Throughput ◽  
Whole Blood ◽  
Test Strip ◽  
Serum Samples ◽  
Blood Samples ◽  
Novel Technologies ◽  
Human Serum Samples ◽  
Biomarker Analysis ◽  
Glucose Test

Novel technologies are needed to facilitate large-scale detection of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) specific antibodies in human blood samples. Such technologies are essential to support seroprevalence studies and vaccine clinical trials, and to monitor quality and duration of immunity. We developed a microfluidic nanoimmunoassay (NIA) for the detection of anti–SARS-CoV-2 IgG antibodies in 1,024 samples per device. The method achieved a specificity of 100% and a sensitivity of 98% based on the analysis of 289 human serum samples. To eliminate the need for venipuncture, we developed low-cost, ultralow-volume whole blood sampling methods based on two commercial devices and repurposed a blood glucose test strip. The glucose test strip permits the collection, shipment, and analysis of 0.6 μL of whole blood easily obtainable from a simple finger prick. The NIA platform achieves high throughput, high sensitivity, and specificity based on the analysis of 289 human serum samples, and negligible reagent consumption. We furthermore demonstrate the possibility to combine NIA with decentralized and simple approaches to blood sample collection. We expect this technology to be applicable to current and future SARS-CoV-2 related serological studies and to protein biomarker analysis in general.

scholarly journals Stability of Busulfan in Frozen Plasma and Whole Blood Samples

2001 ◽  
Vol 47 (4) ◽  
pp. 766-768 ◽  
Author(s):  
Poonkuzhali Balasubramanian ◽  
Alok Srivastava ◽  
Mammen Chandy
Keyword(s):  
Whole Blood ◽  
Blood Samples ◽  
Whole Blood Samples ◽  
Frozen Plasma

scholarly journals Accurate and precise isotope dilution mass spectrometry method for determining glucose in whole blood

1997 ◽  
Vol 43 (5) ◽  
pp. 794-800 ◽  
Author(s):  
Ulf Hannestad ◽  
Arne Lundblad
Keyword(s):  
Mass Spectrometry ◽  
Isotope Dilution ◽  
Glucose Concentration ◽  
Whole Blood ◽  
Accuracy Assessment ◽  
Isotope Dilution Mass Spectrometry ◽  
Internal Standard ◽  
Reference Method ◽  
Gas Chromatography Mass Spectrometry ◽  
Blood Samples

Abstract An accurate and precise method to determine glucose concentration in whole blood is presented. The method, based on isotope dilution gas chromatography–mass spectrometry (ID GC-MS), was developed to be used as a Reference Method for determining glucose concentration in capillary or venous whole blood. Blood samples and standards are pipetted manually with “microcap” micropipettes, which makes it possible to collect samples even at the patient’s bedside. Glucose is quantified as its aldononitrile pentaacetate. [13C6]Glucose is used as an internal standard. Assay of Seronorm and Pathonorm L and H controls by ID GC-MS gave within-run CVs of 0.66%, 0.96%, and 0.92%, respectively. For whole blood with glucose concentrations in the low, normal, and high ranges, the within-run CVs were 1.27%, 0.91%, and 0.78%, respectively. The between-run CV for glucose calculated from 36 separate single analyses of Seronorm was 1.44%. In an accuracy assessment test of the HemoCue blood glucose analyzer, 140 capillary blood samples were measured in parallel after split-sampling. For all samples the HemoCue analyzer results had a mean bias of +2.0% compared with the ID GC-MS results.

scholarly journals A high-throughput microfluidic nano-immunoassay for detecting anti-SARS-CoV-2 antibodies in serum or ultra-low volume dried blood samples

2020 ◽  
Author(s):  
Zoe Swank ◽  
Grégoire Michielin ◽  
Hon Ming Yip ◽  
Patrick Cohen ◽  
Diego O. Andrey ◽  
...  
Keyword(s):  
High Throughput ◽  
Whole Blood ◽  
Large Scale ◽  
Test Strip ◽  
Sample Collection ◽  
Serum Samples ◽  
Blood Samples ◽  
Novel Technologies ◽  
Glucose Test ◽  
Low Volume

AbstractNovel technologies are needed to facilitate large-scale detection and quantification of SARS-CoV-2 specific antibodies in human blood samples. Such technologies are essential to support seroprevalence studies, vaccine clinical trials, and to monitor quality and duration of immunity. We developed a microfluidic nano-immunnoassay for the detection of anti-SARS-CoV-2 IgG antibodies in 1024 samples per device. The method achieved a specificity of 100% and a sensitivity of 98% based on the analysis of 289 human serum samples. To eliminate the need for venipuncture, we developed low-cost, ultra-low volume whole blood sampling methods based on two commercial devices and repurposed a blood glucose test strip. The glucose test strip permits the collection, shipment, and analysis of 0.6 µL whole blood easily obtainable from a simple fingerprick. The nano-immunoassay platform achieves high-throughput, high sensitivity and specificity, negligible reagent consumption, and a decentralized and simple approach to blood sample collection. We expect this technology to be immediately applicable to current and future SARS-CoV-2 related serological studies and to protein biomarker diagnostics in general.

scholarly journals Nanoporous silk films with capillary action and size-exclusion capacity for sensitive glucose determination in whole blood

Lab on a Chip ◽  
2021 ◽  
Author(s):  
Augusto Márquez ◽  
Moliria V. Santos ◽  
Gonzalo Guirado ◽  
Alex Moreno ◽  
Salvador D. Aznar-Cervantes ◽  
...  
Keyword(s):  
Silk Fibroin ◽  
Whole Blood ◽  
Size Exclusion ◽  
Optical Biosensing ◽  
Capillary Action ◽  
Blood Samples ◽  
Test Strips ◽  
Glucose Determination ◽  
Whole Blood Samples ◽  
Silk Films

Nanoporous silk-fibroin films in test strips present capillary action and size-exclusion filtering capacity enabling quick optical biosensing in whole blood samples.

Stability of antioxidant vitamins in whole human blood during overnight storage at 4°C and frozen storage up to 6 months

2018 ◽  
Vol 88 (3-4) ◽  
pp. 151-157 ◽  
Author(s):  
Scott W. Leonard ◽  
Gerd Bobe ◽  
Maret G. Traber
Keyword(s):  
Ascorbic Acid ◽  
Whole Blood ◽  
Healthy Subjects ◽  
Frozen Storage ◽  
Blood Collection ◽  
Plasma Samples ◽  
Optimal Conditions ◽  
Plasma Ascorbic Acid ◽  
Blood Samples ◽  
Sample Handling

Abstract. To determine optimal conditions for blood collection during clinical trials, where sample handling logistics might preclude prompt separation of erythrocytes from plasma, healthy subjects (n=8, 6 M/2F) were recruited and non-fasting blood samples were collected into tubes containing different anticoagulants (ethylenediaminetetra-acetic acid (EDTA), Li-heparin or Na-heparin). We hypothesized that heparin, but not EDTA, would effectively protect plasma tocopherols, ascorbic acid, and vitamin E catabolites (α- and γ-CEHC) from oxidative damage. To test this hypothesis, one set of tubes was processed immediately and plasma samples were stored at −80°C, while the other set was stored at 4°C and processed the following morning (~30 hours) and analyzed, or the samples were analyzed after 6 months of storage. Plasma ascorbic acid, as measured using HPLC with electrochemical detection (LC-ECD) decreased by 75% with overnight storage using EDTA as an anticoagulant, but was unchanged when heparin was used. Neither time prior to processing, nor anticoagulant, had any significant effects upon plasma α- or γ-tocopherols or α- or γ-CEHC concentrations. α- and γ-tocopherol concentrations remained unchanged after 6 months of storage at −80°C, when measured using either LC-ECD or LC/mass spectrometry. Thus, refrigeration of whole blood at 4°C overnight does not change plasma α- or γ-tocopherol concentrations or their catabolites. Ascorbic acid is unstable in whole blood when EDTA is used as an anticoagulant, but when whole blood is collected with heparin, it can be stored overnight and subsequently processed.

Steadiness/stability of antiepileptic drugs in serum, plasma and whole-blood samples under various storage methods

2010 ◽  
Vol 41 (02) ◽  
Author(s):  
N Shazi ◽  
A Böss ◽  
HJ Merkel ◽  
F Scharbert ◽  
D Hannak ◽  
...  
Keyword(s):  
Antiepileptic Drugs ◽  
Whole Blood ◽  
Blood Samples ◽  
Storage Methods ◽  
Whole Blood Samples

Monitoring of r-Hirudin Anticoagulation during Cardiopulmonary Bypass – Assessment of the Whole Blood Ecarin Clotting Time

1997 ◽  
Vol 77 (05) ◽  
pp. 0920-0925 ◽  
Author(s):  
Bernd Pötzsch ◽  
Katharina Madlener ◽  
Christoph Seelig ◽  
Christian F Riess ◽  
Andreas Greinacher ◽  
...  
Keyword(s):  
Cardiopulmonary Bypass ◽  
Whole Blood ◽  
Heart Surgery ◽  
Ex Vivo ◽  
Open Heart Surgery ◽  
Clotting Time ◽  
Blood Samples ◽  
Alternative Approach ◽  
Ecarin Clotting Time

SummaryThe use of recombinant ® hirudin as an anticoagulant in performing extracorporeal circulation systems including cardiopulmonary bypass (CPB) devices requires a specific and easy to handle monitoring system. The usefulness of the celite-induced activated clotting time (ACT) and the activated partial thromboplastin time (APTT) for r-hirudin monitoring has been tested on ex vivo blood samples obtained from eight patients treated with r-hirudin during open heart surgery. The very poor relationship between the prolongation of the ACT and APTT values and the concentration of r-hirudin as measured using a chromogenic factor Ila assay indicates that both assays are not suitable to monitor r-hirudin anticoagulation. As an alternative approach a whole blood clotting assay based on the prothrombin-activating snake venom ecarin has been tested. In vitro experiments using r-hirudin- spiked whole blood samples showed a linear relationship between the concentration of hirudin added and the prolongation of the clotting times up to a concentration of r-hirudin of 4.0 µg/ml. Interassay coefficients (CV) of variation between 2.1% and 5.4% demonstrate the accuracy of the ecarin clotting time (ECT) assay. Differences in the interindividual responsiveness to r-hirudin were analyzed on r-hirudin- spiked blood samples obtained from 50 healthy blood donors. CV- values between 1.8% and 6% measured at r-hirudin concentrations between 0.5 and 4 µg/ml indicate remarkably slight differences in r-hirudin responsiveness. ECT assay results of the ex vivo blood samples linearily correlate (r = 0.79) to the concentration of r-hirudin. Moreover, assay results were not influenced by treatment with aprotinin or heparin. These findings together with the short measuring time with less than 120 seconds warrant the whole blood ECT to be a suitable assay for monitoring of r-hirudin anticoagulation in cardiac surgery.

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