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Sta r max analyzer

Manufactured by Diagnostica Stago
Sourced in France

The STA-R Max analyzer is a coagulation testing instrument designed for use in clinical laboratories. It is capable of performing a wide range of coagulation assays, including prothrombin time (PT), activated partial thromboplastin time (aPTT), and fibrinogen tests. The STA-R Max utilizes optical detection methods to measure the clotting time of patient samples.

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8 protocols using sta r max analyzer

1

Comprehensive Coagulation Biomarker Analysis

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Blood was collected at ICU admission for each patient on 0.109 mol/L trisodium citrate tube (BD Vacutainer, BD Diagnostics, Sparks, MD, USA). All analyses were performed on platelet-poor plasma obtained after a double centrifugation at 2500× g for 15 min at room temperature.
The following biomarkers were measured in the derivation and validation cohorts: Prothrombin time and fibrinogen were measured on an STA-R Max analyzer (Diagnostica Stago, Asnières-sur-Seine, France) using STA® Neoplastin® R (Diagnostica Stago) and STA®Liquid-Fib (Diagnostica Stago); D-dimers levels were measured in µg/mL (fibrinogen equivalent units) using an immunoturbidimetric latex-particle assay (Liatest® DDI-Plus, Diagnostica Stago) on the STA-R Max analyzer (Diagnostica Stago); and Von Willebrand factor antigen (VWF:Ag) was measured using an immunoturbidimetric assay (LIAPHEN® VWF:Ag, HYPHEN BioMed, Andresy, France) on a CS 2400 analyzer (Sysmex, Kobe, Japan). Endocan was measured using the JDIYEK® ELISA Kit (Biothelis, Lille, France). Other laboratory blood tests including a complete blood count, CRP, procalcitonin (PCT), liver transaminases, bilirubin, and creatinine were measured by standard methods as part of the patient’s care in the Biology and Pathology Center of Lille University Hospital.
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2

Quantifying Plasma Fibrinogen in COVID-19

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We quantified the plasma FM level in platelet-poor plasma (STA-Liatest FM, Diagnostica Stago, France) using a STA-R Max analyzer (Diagnostica Stago, as recommended by the manufacturer). According to the manufacturer's recommendation and calibration curves, the limit of detection was 6 µg/mL. Furthermore, as part of a requirement of the COFRAC ISO 15189 label of our laboratory, the limit of quantification was determined in our coagulometers and was identified as 7 µg/mL. Hence, positivity for FM was indicated by values above 7 µg/mL. The local protocol for COVID-19 management suggested the physician to measure FM in COVID-19 patients at admission and thereafter 72 h.
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3

Quantification of Direct Oral Anticoagulants

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Concentrations of dabigatran were estimated using one Ecarin chromogenic assay (STA-ECA-II, Diagnostica Stago), and concentrations of apixaban, edoxaban, and rivaroxaban with the corresponding procedure using the chromogenic assay (STA-liquid anti-Xa, Diagnostica Stago). All these procedures were performed on the STA-R MAX analyzer (Diagnostica Stago). The limit of quantification of the corresponding apixaban, dabigatran, edoxaban, and rivaroxaban assays were 15, 27, 20, and 25 ng/mL, respectively.
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4

Heparin Neutralization for Thrombin Generation

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Samples sent to the laboratory for HIT diagnosis work up often contained heparin because blood was collected early, as soon as HIT was suspected and TG is very sensitive to presence of heparin in the plasma sample [20 (link), 21 (link)]. Consequently, we had to perform the assay after neutralization of heparin. For this, we considered two reagents: polybrene (hexadimethrine bromide, Sigma-Aldrich, France) at concentrations described elsewhere [22 (link)] and heparinase (Dade Hepzyme®, Siemens Healthcare Diagnostics, Marburg Germany), using one vial of product for 1mL of plasma, according to manufacturer’s instructions. In preliminary experiments, plasmas from two healthy controls and five non-HIT patients under unfractionated heparin (UFH) and low molecular weight heparin (LMWH) were incubated with polybrene or Dade Hepzyme® at room temperature for 15 min before checking neutralization efficiency as follows. Coagulation tests (APTT, PT) and chromogenic anti-Xa assay (STA®-Liquid Anti-Xa, Diagnostica Stago, France) were performed with a STAR® Max analyzer before and after heparin neutralization. As some residual anti-Xa levels (0.10–0.20 IU/mL) were observed in polybrene-treated samples, we performed the study treating each individual patient’s sample with Dade Hepzyme® before TG study.
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5

Anticoagulant Activity Measurement Protocol

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For patients on apixaban, rivaroxaban, and LMWH, the estimated concentrations or the anti‐Xa activity have been measured using the STA‐Liquid Anti‐Xa (Diagnostica Stago) and the corresponding calibrators and controls according to the recommendations of the manufacturer on an STA‐R Max analyzer (Diagnostica Stago). For dabigatran samples, the estimated dabigatran plasma concentrations have been measured using the STA‐ECA II (Diagnostica Stago) with the corresponding calibrators and controls. For VKA patients, the INRs have been measured with the STA–Neoplastine R (Diagnostica Stago) according to the recommendations of the manufacturer. For healthy individuals, the prothrombin time (PT) and the activated partial thromboplastin time (aPTT) have been assessed using the STA–Neoplastine R (Diagnostica Stago) and the STA‐C.K. Prest (Diagnostica Stago) according to the recommendations of the manufacturer.
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6

Extracellular Vesicle Procoagulant Phospholipid Assay

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Procoagulant phospholipids (ProcoagPPL) associated with extracellular vesicles (phosphatidylserine exposure), formerly known as microparticles, were assessed in plasma samples with a commercially available assay (STA®-Procoag PPL, Diagnostica Stago, France). The assay measures the clotting time initiated with added factor Xa and calcium to the plasma sample mixed with a normal, procoagulant phospholipid-depleted, plasma. The shorter the clotting times, the greater the procoagulant phospholipids plasma levels.
STA®-Procoag PPL is considered to be insensitive to heparin levels up to 1.5 IU anti-Xa/mL (unfractionated heparin) or 2.0 IU anti-Xa/mL (low molecular weight heparin). The kit was used according to manufacturer’s instructions on STA R® Max analyzer (Diagnostica Stago, France).
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7

Antigenic and Functional Assay of FXI and FXII

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Antigenic levels of FXI and FXII were determined using a matched-pair antibody set for human ELISA provided by Affinity Biologicals. Thawed plasma samples were added to Dade Hepzyme (Siemens Healthineers) after which the functional assay was performed on the STA-R Max analyzer (Diagnostica Stago) using STA—ImmunoDef FXI and FXII reagents (Diagnostica Stago). Cut-off values of antigenic and functional FXI and FXII deficiency were based on an earlier study in healthy children [14 (link),15 (link)].
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8

Quantifying Soluble Fibrin Levels

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Fibrin monomers (FM), also known as soluble fibrin, result from thrombin action on fibrinogen, when fibrinopeptides A are released and fibrin monomers are not polymerized to such an extent that they are no longer soluble [12 (link)]. FM levels were measured using an immunoturbidimetric assay (STA®- Liatest® FM, Diagnostica Stago, France) on STA R® Max analyzer according to manufacturer’s instructions. The assay principle is based on immunocapture of FM by a mouse monoclonal anti-human FM antibody coated onto latex microparticles and OD is converted into FM concentration using a dedicated calibration (STA®-Liatest® FM Calibrator, Diagnostica Stago, France).
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