CoaguChek XS (Roche Diagnostics) is a small, handheld device for the self-testing of INR. The device shows good analytic performance 19 with an analytical variation (CVa) of approximately 3% 20 and is easy for patients to use after thorough training. 20 Capillary blood from the finger is applied to a test strip placed in the POC device for analysis of the INR. The reagents SPA50/SPAþ (Stago, France) were used for analysis of INR in citrated plasma on the hospital instruments, STA-R and StaR Evolution (Stago). Standard procedures for internal and external controls were followed, and gave acceptable results. Results from the split-sample analysis (comparison of Coagu-Chek XS INR result with hospital INR result) showed that the INR values during the training period were within the acceptable limits given by the International Organization for Standardization for self-testing devices 21 (►Supplementary Fig. S1, available in the online version).
Sta r
Manufactured by Stago
Sourced in France
The STA-R is a laboratory coagulation analyzer designed to perform a variety of hemostasis tests. It utilizes optical detection technology to measure the clotting time of samples. The STA-R can accommodate multiple sample types and provides consistent and reliable results.
Automatically generated - may contain errors
Lab products found in correlation
Coaguchek xs, by Roche (1 mentions)
Sta r evolution, by Stago (1 mentions)
Staclot la, by Diagnostica Stago (1 mentions)
Hemosil synthasil, by Werfen (1 mentions)
Dade innovin, by Siemens (1 mentions)
Mda 180, by Organon (1 mentions)
Acl top 750, by Werfen (1 mentions)
Biophen heparin lrt, by Sysmex (1 mentions)
Cs 5100, by Sysmex (1 mentions)
Bcs xp, by Siemens (1 mentions)
Thrombin reagent, by Siemens (1 mentions)
Zymutest, by Hyphen Biomed (1 mentions)
Cs2100i, by Sysmex (1 mentions)
Aeroset, by Abbott (1 mentions)
7 protocols using sta r
1
Evaluation of CoaguChek XS INR Device
2
Standardizing Coagulation and Antibody Assays
3
LMWH Anti-Xa Measurement Across Laboratories
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As an external validation, the LMWH‐calibrated anti‐Xa measurements were conducted in nine referring laboratories using the same sample for the cross‐sectional study mentioned above. We aimed to confirm the applicability of the specific cut‐offs to other laboratories. Measurements were conducted after inclusion, but before freezing the samples. Local reagents and analysers established for the determination of LMWH drug levels were utilised. The following reagents and analysers were used: Biophen® Heparin LRT on a Sysmex CS‐5100 (four laboratories), Biophen® Heparin LRT on a BCS XP (Siemens Healthineers; one laboratory), Biophen® Heparin LRT on an ACL Top 750 (Instrumentation Laboratory; two laboratories), STA‐LIQUID anti‐Xa on a STA‐R (Stago; one laboratory), and HemosIL liquid anti‐Xa on ACL Top 750 (one laboratory).
4
Fibrinogen Level and Hospital Stay
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The exposure variable was the fibrinogen level, which was measured after an 8-h fast on the day of admission. The blood samples for fibrinogen testing were collected in vacuum blood collection tubes, and the fibrinogen level was measured by the clotting method using an STA-R automated coagulation analyzer (Stago, France). The outcome variable was LOS, which refers to the time interval between the date of admission and the discharge19 (link).
5
Comprehensive Coagulation Factor Analysis
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FII, FV, FVII, FX (Neoplastine R), FVIII, FIX, FXI, FXII (CK Prest) activity levels were measured by clotting assays using specific factor‐depleted plasma as substrate on Sta‐R (Stago, Paris, France). Fibrinogen level (Clauss method, Thrombin Reagent; Siemens, Marburg, Germany), FXIII activity and vWF antigen and activity (FXIIIact/subs, vWF Reag and vWF Ac Reagens; Siemens) measurements were performed on a Sysmex CS2100i. α2‐antiplasmin level was measured using a chromogenic assay (Stachrom; Stago), tissue plasminogen activator (tPA) and plasminogen activator inhibitor 1 (PAI‐1) activity were measured using bio‐immunoassays (Zymutest, Hyphen‐BioMed, Neuville‐sur‐Oise, France).
6
Liver Failure Biomarker Evaluation
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At 0, 36, and 60 h, parameters to quantify the severity of liver failure were collected including the international normalization ratio (INR), and alanine aminotransferase, aspartate aminotransferase, alkaline phosphatase, γ-glutamyl transpeptidase, total bilirubin, and creatinine levels.
Blood ammonia was measured using an ammonia test kit (ARKRAY, Tokyo, Japan) with a detection range between 10 and 400 μg/dL. INR was quantified using STA-R (Diagnostic Stago, Asnieres, France) in the emergency laboratory at the First Affiliated Hospital, College of Medicine, Zhejiang University. Serum alanine aminotransferase, aspartate aminotransferase, alkaline phosphatase, γ-glutamyl transpeptidase, total bilirubin, and creatinine levels were measured using an automated biochemical analyser (Abbott Aeroset; Abbott Laboratories, Chicago, IL, USA) in the same laboratory.
Blood ammonia was measured using an ammonia test kit (ARKRAY, Tokyo, Japan) with a detection range between 10 and 400 μg/dL. INR was quantified using STA-R (Diagnostic Stago, Asnieres, France) in the emergency laboratory at the First Affiliated Hospital, College of Medicine, Zhejiang University. Serum alanine aminotransferase, aspartate aminotransferase, alkaline phosphatase, γ-glutamyl transpeptidase, total bilirubin, and creatinine levels were measured using an automated biochemical analyser (Abbott Aeroset; Abbott Laboratories, Chicago, IL, USA) in the same laboratory.
7
Molecular Diagnosis of Hemostasis Disorders
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Patients and their family members were included. FVIII:C was measured by the one‐stage coagulative method (Diagnostic Stago) on Stago STA‐R automated coagulation factor analyzer. VWF antigen (VWF:Ag) was detected by turbidimetric inhibition immuno assay on ACL TOP TM Hemostasis Testing System (Instrumentation Laboratory). VWF ristocetin cofactor (VWF:RCo) was performed by washed platelet aggregometry on a AggRAM platelet aggregation analyzer (Helena Laboratory). PBMCs were collected and genome DNA was extracted. Laboratory tests for the two patients were shown in Table 1 .
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