Use of PSI on CS instruments
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1 Johan Claes, Version 01, 1 st September 2016 User day hemostasis 2016 Use of PSI on CS instruments Restricted Siemens Healthcare GmbH, 2016
2 Hemostasis Lab Challenges Preanalytical problems in Haemostasis Patient ID Collecting blood needle, catheters, discard tube, order of draw Anticoagulant, tube composition, bung Sample mixing Sample transport Sample storage Sample processing Sample quality checks - haemolysis, filling Hemolyzed sample sample In most cases errors are directly related to specimen collection! 54 % Others Others Incorrect sample Insufficient sample Source: Lippi et al (2006), Lippi et al (2008) Page 2 Restricted Siemens Healthcare GmbH, 2016
3 Preanalytical Sample Integrity (PSI) Checks Probe 1 Probe Upper 575 level Absorbance! Lipemia Hemolysis Icterous 1 st volume check Lower level 2 nd volume check Wavelength (nm) Hemolytic Correct first time Preanalysis Analysis Results Page 3 Restricted Siemens Healthcare GmbH, 2016
4 Preanalytical Sample Integrity (PSI) Checks Page 4 Restricted Siemens Healthcare GmbH, 2016
5 HIL - Frequency of samples rejection Example of Haemolysis Plasma Haemoglobin 15 g/l 6 g/l 1 g/l control Page 5 Restricted Siemens Healthcare GmbH, 2016
6 Preanalytical Sample Integrity (PSI) Checks Page 6 Restricted Siemens Healthcare GmbH, 2016
7 HIL - What level of haemolysis is routinely encountered? 59 consecutive haemolysed samples rejected for visible haemolysis* n Low Hb concentration are more frequent , Plasma Hb g/l *Example from systems validations in the UK (Sheffield Teaching Hospitals ) Page 7 Restricted Siemens Healthcare GmbH, 2016
8 APPT Tests Hemostasis Lab Challenges Preanalytical Risks to Diagnostic Accuracy Increasing levels of hemolysis are associated with shorter APTT results 1 Such a shift can cause abnormal samples to produce normal results Reference interval of APTT Test on STA Compact System: Reference interval of APTT Test on Sysmex CS-2100i System: Controls (CS-2100i) Heparin (CS-2100i) Controls (STA Compact) Heparin (STA Compact) The green and blue lines/symbols describe the effect of increasing levels of hemolysis on control blood samples, while the orange and maroon lines/symbols describe the effect on the same samples spiked with unfractionated heparin (0.15 IU/ml) Data on file, Siemens Healthcare Diagnostics 1. The Effects of Hemolysis and Primary Tube Under-filling on Several Hemostasis Assays; Automatic Detection by the Sysmex CS-2100i System. De Haan, Hoogendoorn, et al Level of hemolysis (free Hb; mg/dl) Page 8 Restricted Siemens Healthcare GmbH, 2016
9 HIL - Effect of Haemolysis 6 normal subjects Vacutainer 0.109M trisodium citrate (3.2%) Whole blood frozen Lysed cells added to plasma from same subject 12 different mixtures prepared Mean plasma haemoglobin 0 20 g/l (10-15% haemolysis) REAGENTS: PT reagent APTT reagent Second APTT reagent TT reagent Fib (Clauss reagent) D-Dimer reagent Page 9 Restricted Siemens Healthcare GmbH, 2016
10 APTT (sec) HIL - Effect of Haemolysis Artificial Haemolysis APTT reagent - CS series Influence of Hemolysis on APTT results is patient dependent. 18 <2 g/l 2.5g/l 4.5g/l 6g/l 7.8g/l 9.5g/l 10.8g/l 12.8g/l Plasma Haemoglobin 15g/l 17g/l 19.7g/l 20.7g/l Page 10 Restricted Siemens Healthcare GmbH, 2016
11 APTT (sec) HIL - Effect of Haemolysis Artifical haemolysis second APTT reagent - CS series Influence of Hemolysis on APTT results is patient and/or reagent dependent. 24 <2 g/l 2.5g/l 4.5g/l 6g/l 7.8g/l 9.5g/l 10.8g/l 12.8g/l Plasma Haemoglobin 15g/l 17g/l 19.7g/l 20.7g/l Page 11 Restricted Siemens Healthcare GmbH, 2016
12 Diference H/lsed - clear APTT (sec) HIL - Effect of Haemolysis Is the effect greater at higher levels of haemolysis? Patient samples APTT -20,0 1,0 2,0 3,0 4,0 5,0 6,0 7,0 8,0 9,0 10,0 Plasma Hb (g/l) Slight hemolysis have an higher impact? Page 12 Restricted Siemens Healthcare GmbH, 2016
13 HIL - Effect of Haemolysis Samples falsely raised above DDimer above the VTE cutoff (0.5 µg/ml) Haemolysed DDimer (µg/ml) Clear DDimer (µg/ml) Plasma Hb (g/l) HIL check n = 4 ( 9%)! Potentially unnecessary ultrasounds COST? Page 13 Restricted Siemens Healthcare GmbH, 2016
14 HIL Effect of Lipemic Sample Effects of Lipids on routine coagulation tests* ClinOleic 20% intravenous fat emulsion (Baxter) at 1:40 dilution in plasma PT-sec APTT-sec Fbg-g/L TT-sec No lipid Lipid No lipid Lipid No lipid Lipid No lipid Lipid STA N = Instrument No result CS-2x *Example from systems validations in the UK (Sheffield Teaching Hospitals ) Page 14 Restricted Siemens Healthcare GmbH, 2016
15 Underfilling Tubes Case Report Effect of under filling the tube First sample PT 104 seconds (properly filled 1 ml sample) Second sample (no treatment) PT 14 secs (properly filled 5ml sample)? Artefact? Wrong patient Page 15 Restricted Siemens Healthcare GmbH, 2016
16 Underfilling Tubes Case Report Effect of under filling the tube Third sample PT 14 seconds First sample - mixed 0.5 ml blood with 0.5ml anticoagulant in a 5 ml tube - this mix was added to a paediatric (1 ml) tube with further 0.1 ml anticoagulant CITRATE excess prolonged PT from 14 sec to 104 seconds Page 16 Restricted Siemens Healthcare GmbH, 2016
17 APTT Time (s) Underfilling Tubes APTT / CA1500 (Mean of 20 normals) It is admitted that a threshold of 80% filling is the ultimate lower limit. (Ray et al., 1991) % Filled Underfilling of the tube can have a significative impact on APTT time Page 17 Restricted Siemens Healthcare GmbH, 2016
18 HIL recommandations from recent studies Test Specific assessment of effects of haemolysis on citrated blood samplels using Sysmex CS series analysers Issued from the collaboration between Sysmex and Royal Hallamshire Hospital Scheffield UK On CS series analysers with Siemens reagents To asses test specific thresholds for effects of haemolysis on coagulation tests. Page 18 Restricted Siemens Healthcare GmbH, 2016
19 HIL recommandations from recent studies Page 19 Restricted Siemens Healthcare GmbH, 2016
20 HIL recommandations from recent studies Page 20 Restricted Siemens Healthcare GmbH, 2016
21 HIL recommandations from recent studies Page 21 Restricted Siemens Healthcare GmbH, 2016
22 HIL recommandations from recent studies Page 22 Restricted Siemens Healthcare GmbH, 2016
23 HIL recommandations from recent studies Page 23 Restricted Siemens Healthcare GmbH, 2016
24 HIL recommandations from recent studies Assay PT INN PT THS Parameter sec INR D-Fib sec INR D-Fib Acceptance Criteria *+-15% Recommandations Hb at Flag level Level 4 or Level 5 without D- Fib 240 mg/dl *+-15% Level mg/dl APTT FS sec *+/- 15% Level 1 40 mg/dl APTT FSL sec *+/- 15% Level 1 40 mg/dl Fbg g/l *+/- 15% Level mg/dl Thrombin Time sec *+/- 15% Level mg/dl AT % *+/- 10% Level mg/dl PC % *+/- 10% Level mg/dl FXIII % *+/- 15% Level 1 40 mg/dl D-Dimer mg/l *+/- 15% Level 1 40 mg/dl Page 24 Restricted Siemens Healthcare GmbH, 2016
25 HIL recommandations from recent studies Summary The level of haemoglobin causing >15% changes was different in spiked samples compared to genuine patient samples for some tests. D-Dimer, FXIII and APTT were more tolerant of haemolysis in spiked samples. Taking all data into account the following flag levels were required to ensure 15% change in results (10% for AT, PC) with equivalent plasma Hb in brackets: Page 25 Restricted Siemens Healthcare GmbH, 2016
26 HIL recommandations from recent studies Summary Level 5 (>300 mg/dl) - PT (Thromborel S), Clauss Fbg, Thrombin Time; Level 4 ( mg/dl) - PT (lnnovin), Protein C; Level 3 ( mg/dl) - Antithrombin Level 1 ( mg/dl) - APTT (Actin FS, Actin FSL), FXIII, D-Dimer. Page 26 Restricted Siemens Healthcare GmbH, 2016
27 PSI Checks Value through Sample Integrity Checks PSI technology on Sysmex CS Systems integrates sample integrity checks into routine workflow: Automates visual inspection of sample tubes Helps to detect the most prevalent factors that can cause errors Reduces risk of patient management based on erroneous results Boosts lab confidence and image Value of PSI technology: Reduces the need for manual sample inspections Reduces the risk for human errors Allows scarce resources to focus on other tasks Checks for adequate sample volume Scans for hemolysis and other HIL factors Flags and manages questionable samples as defined by user Provides first-run test accuracy Supports accurate patient diagnosis Helps allow correct and timely treatment Increases confidence in results Supports inter-lab consistency Helps builds trust with physicians Result Improved Patient Care Page 27 Restricted Siemens Healthcare GmbH, 2016
28 Preanalytical Sample Integrity (PSI) Checks Onboard Reducing Preanalytical Risk Preanalytical Sample Integrity (PSI ) checks Multiwavelength analysis Autoverification Direct LIS connection Patients and physicians Preanalysis Analysis Review Results Accurate diagnosis Page 28 Restricted Siemens Healthcare GmbH, 2016
29 Now s our time to inspire the future of healthcare together Engineering success. Pioneering healthcare. Restricted Siemens Healthcare GmbH, 2016
Use of PSI on CS instruments
Johan Claes, Version 01, 1 st September 2016 User day hemostasis 2016 Use of PSI on CS instruments Restricted Siemens Healthcare GmbH, 2016 Hemostasis Lab Challenges Preanalytical problems in Haemostasis
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