HAEMATOLOGY DEPARTMENT, HOSPITAL UNIVERSITI SAINS MALAYSIA TITLE : PROCEDURE NO. ESR HUSM/HEMA-UPT/STM-R4 VERSION NO. VERSION DATE.

1 24.03.2011

APPROVED BY:

... ASSOC PROF DR ROSLINE HASSAN HEAD OF HAEMATOLOGY DEPARTMENT

CONTROLLED COPY NO: 1 REGISTERED HOLDER HAEMATOLOGY LABORATORY

RECORD OF REVIEW/AMMENDMENT DATE VERSION NO. DETAIL OF AMMENDMENT BY

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STANDARD TECHNICAL MANUAL

HAEMATOLOGY DEPARTMENT, HOSPITAL UNIVERSITI SAINS MALAYSIA TITLE : PROCEDURE NO.

PREPARED BY DESIGNATION CHECKED BY DESIGNATION AUTHORISED BY DESIGNATION

ESR HUSM/HEMA-UPT/STM-R4

VERSION NO. VERSION DATE.

1 24.03.2011

: AHMAD ZAKWAN MUSTAFA : DEPUTY DOC CON / SAFETY OFFICER / SCIENTIFIC OFFICER : DR ABDUL RAHIM HUSSEIN : HAEMATOLOGIST : ASSOC PROF DR ROSLINE HASSAN : HAEMATOLOGIST/LAB DIRECTOR

1. OBJECTIVE To perform Erythrocyte Sedimentation Rate analysis (ESR) via semi-automated method. 2. METHOD
2.1. Semi-automated Method (infrared beam).

3. PRINCIPLE
3.1. Westergren reference.

4. REQUIREMENTS
4.1. EQUIPMENT

4.1.1 Disposable Plastic Transfer Pipet 4.1.2 ESR measuring analyzer (Mixrate-X20)
4.2. REAGENT REAGENT Sodium Citrate ESR Tube (8 x 120 mm) Quality Control Materials (2 levels) CAPACITY PER CONTAINER 1.2ml CODE NUMBER 106H3704 Please refer kit package* may differ by batch/lot STORAGE (C) Room temperature 22C 2 to 4C SHELF LIFE (days) 6 months

9ml

6 months

4.3. SPECIMEN

4.3.1

Human blood sample in K2 EDTA 2ml/3ml container. (for adult and neonates)

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HAEMATOLOGY DEPARTMENT, HOSPITAL UNIVERSITI SAINS MALAYSIA TITLE : PROCEDURE NO. 5. PROCEDURE
NO. 5.1 ACTIVITY INSTRUMENT START-UP 5.1.1 POWER ON
a. b. c. d. Connect power supply outlet to the instrument. Inspect thermal paper in the printer. Once connected, turn on the instrument. Each time the instrument turned on, it performs self-check for proper operations.

ESR HUSM/HEMA-UPT/STM-R4

VERSION NO. VERSION DATE.

1 24.03.2011

RESPONSIBILITY

MLT

5.1.2 STAND BY & READY

a. Once the initialization successful, the main menu is displayed on the screen of the instrument. b. Instrument is now ready for operation.

MLT

5.2

QUALITY CONTROL 5.2.1 Storage, Preparation & Running

a. b. c. d. e. f. g. Obtain the material form a local vendor or third party. Store the material according the instruction on the package. Prepare each level of the materials in a new tube. Pipette the required amounts until the mark on the ESR tube. Select QC mode on the instrument. Mix the materials carefully with 5 times gentle inversion. Scan its barcode (if barcoded) or key in its barcode number and place in any of the instrument channel.

MLT

5.2.2 Validation
a. Record the IQC results into the ESR QC work sheet. b. Monitor and validate the QC performance.

MLT/SO

5.3

SAMPLE PROCESSING 5.3.1 Preparation and Running

a. b. c. d. e. Check if the sample is enough and suitable. Record the patient samples in the ESR record book. Pipette the required amounts until the mark on the ESR tube. Mix the sample gently with 5 times gentle upside down inversion. Select from the instrument screen the desired channel, scan its barcode (if barcoded) or key in its barcode number and place it in the selected channel. f. The result can be obtained within 1 hour later. g. Remove and dispose the sample once the test completed.

MLT

5.3.2 Validating and release of results.

a. Check the result for any errors in measurement or sample. b. Transcript the result from the instrument to the ESR Results Record Book, to the Request Form, sign and key-in in the LIS Hematology. c. Validate, release in LIS and dispatch accordingly.

MLT/SO

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STANDARD TECHNICAL MANUAL

HAEMATOLOGY DEPARTMENT, HOSPITAL UNIVERSITI SAINS MALAYSIA TITLE : PROCEDURE NO. ESR HUSM/HEMA-UPT/STM-R4 VERSION NO. VERSION DATE. 1 24.03.2011

6. LIMITATION/SOURCES OF ERROR
6.1

Blood cells morphology will deteriorate after 4 hours of sample collection. In accordance with the recommendations of the International Committee for Standardization in Hematology (ICSH), blood samples collected in this manner should be tested within 4 hours if left at room temperature, or within 6 hours if stored at 4C. Samples must be brought to room temperature prior to analysis.

6.2 6.3 6.4 6.5 6.6 6.7 6.8 6.9

Anemic samples under 2.5-million/cubic mm RBC can give reading problems. Abnormally high or low HCT, with other hemoglobinopathies, may affect results. Diluted specimen. Bubbles. Strongly hemolyzed or lipemic samples may alter reading capabilities. Sudden agitation. Temperature outside the given range will be accepted as 15C min and 32C max. Exposure to direct sunlight.

6.10 Foaming of sample. 6.11 Tube inclination. 6.12 Clotted specimen.

7. REFERENCE RANGE
Please refer appendix 1

8. RESULTS
8.1. Result will be indicated in mm/h unit (Westergren reference method). 8.2. The measurement range/linearity is 1 140 mm/h. 8.3. Readings > 140mm/h will be indicated as >140mm/h only.

9. REFERENCES
9.1 Mixrate-X20 user manual (MHT/DL 230)

End of Document

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