Application of POCT in Hospital Setting : hospital

experience Irwan Idris

Outline of Presentation

n POCT in General n POCT in Glucose measurement n POCT in Blood Gas Analysis n POCT in Troponin I measurement n Summary

Role of Lab. Manager

n  Need a POCT ? n  Cost ? n  Central / Satellite / Stat Lab n  How to choose POCT n  Who should perform (trained) n  Accurate & Precision n  Results LIS / HIS

Choose POCT

n  Manual / MSDS n  Accuracy & Precision n  Evidence based (Clinical study) n  FDA approved n  QA n  Functional sensitivity (Immunology) n  Each cartridge packed n  Cost

Quality Assurance

n  System QC n  Test Cartridge QC n  External QC

System QC

n  The Reader has error checking and self diagnostic function (to confirm acceptable operator technique, sample handling and assay performance)

n  If a problem is detected, a message is displayed

n  Sample results are displayed only after all QC performance requirements have been met

Test Cartridge QC

n  Every Test cartridge has an internal standard zone (QC)

n  If the internal QC control does not met specifications no results

POCT : BG Meter

n  Accurate – especially at low glucose concentration

n  Reliable – good precision, CV <5% n  Test method (Specific) – no interferences n  Easy to use – simple, quick, low blood

volume

POCT : BG Meter n  Nursery : high Hematocrit, low level of

Glucose (precision) n  TAT < 20” n  Each test packed

n  Do we need Keton level n  ISO 15197 compliant n  Easy to interface

ISO 15197 criteria (BG Meter) 95 % of glucose values should fall within 15 mg/dL of the target value at a glucose concentration < 76 mg/dL (<4.2 mmol/L) and within 20% of the target value at a glucose concentration ≥ 76 mg/dL (> 4.2 mmol/L) CVw Glucose 5.7 % (Cited from Scand J Clin Lab Invest 1999;59:491-500. Updated on 2010)

Analyte Serum

Bias % Imprecision %

TEa (%) p<0.05

Method CV (%)

SGPT 12 12.2 15.2 3.2 Albumin 1.3 1.6 3.9 3.4

Bil-total 11.4 11.9 31.1 3 Ca total 0.8 1 2.4 2.2 Cholesterol 4 2.7 8.5 2.3 Creatinine 3.8 2.7 8.2 1 Glucose 2.2 2.9 6.9 1.7 Sodium 0.3 0.4 0.9 0.7 Uric acid 4.6 4.5 12.4 0.7 HB 1.8 1.4 4.1 1

Cited from Scand J Clin Lab Invest 1999;59:491-500. Updated on 2010

POCT : Blood Gas Analyzer

n  Each Test cartridge has an Internal QC n  If Internal QC fail No results n  Reagent and Electrode single use Stable Good Accuracy & Precision

n  Bedside TAT <<

n  Costly

Test Range N = 50

POCT

Deming Regression

pH 7.014-7.531

AE B6

Y=1.23X-31.8 Y=1.05X-7.2

pO2 24.7-185.5 mmHg

AE B6

Y=0.45X+21 Y=0.99X+0.89

pCO2 5.5-56.7 mmHg

AE B6

Y=0.94X+0.67 Y=0.99X+0.89

Correlation of POCT results with Central Lab

Preceeding of Singapore Healthcare.Vol. 20. Number 3. 2011

POCT : Troponin I

n The lower limit of detection (LLD) TnI is the lowest TnI level that can be distinguished from 0.

n Functional sensitivity and CV ?

POCT : Troponin I

n Method n Flow Through EIA n Flow Through Chemiluminescence

IA

n Chemiluminescence IA (Magnetic separation)

Functional Sensitivity

n 0.1 ng/mL : CV 20% n 0.2 ng/mL : CV 10 %

BG Meter Blood Gas A. Troponin I

Pre- Analytic

Capillary Volume ?

Bubble ? Immediate Anticoagulant ? Ca++ : (lyophilized L. Heparin /Ca balance L. Heparin

W. blood : EDTA/ Heparin

Analytic Hypotension/ Shock, Ht Uric Acid Ascorbic acid Drugs

RF/ Heterophyl Antibody Anti Mouse Ig G

Summary

n Glucose : Clinical Analyzer more Accurate & Precise than POCT

n BGA : POCT more Accurate & Precise than BG Analyzer

n Troponin I : Method, Functional sensitivity and CV

Thank you For your Attention