BIOLINE DIAGNOSTICS LLP

H, 1478 DSIDC Industrial area, Narela, Delhi, 110040

STANDARD OPERATING PROCEDURE
Doc. No. QC/PSTP/009 1 /3
Doc. Name STP for CK-MB Revision No.

Effective Date Next Review

1.0 Objective:
To the describe procedure for testing of CK-MB .

2.0 SCOPE
This STP is applicable for the testing of CK-MB
3.0[2.0] RESPONSIBILITY
Officer/ Executive - Quality Control

4.0[3.0] ACCOUNTABILITY
Manager - Quality Assurance

5.0[4.0] REFRENCE
QA/SOP/001: Writing of Document/Procedure

6.0[5.0] PROCEDURE
6.1 Visual Check:
6.1.1 Reagent bottle color: Check R1,R2 reagent bottle color according to the pack
configuration file. It shall be,
R1: SN White plastic bottle with cap.
R2: SN White plastic bottle with cap.
6.1.2 Reagent color: Take 1ml of CK-MB reagent R1 R2 in a clear glass test tube and
examine under bright light for any turbidity or suspended particles.
R1: Should be clear transparent colorless solution .
R2: Should be clear transparent colorless solution.
6.2 Testing procedure: Before performing the test, bring the reagents R1 R2 at room
temperature. Testing is to be done with biochemistry analyzer (sop).
6.3.1 Set Parameter: Set the below parameter in biochemistry analyzer before carrying out the
test:

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 BIOLINE DIAGNOSTICS LLP
H, 1478 DSIDC Industrial area, Narela, Delhi, 110040
STANDARD OPERATING PROCEDURE
Doc. No. QC/PSTP/009 2 /3
Doc. Name STP for CK-MB Revision No.

Effective Date Next Review

Mode- Kinetic
Filter 340 nm
Reaction direction Increasing/positive
Temperature 37˚C
Delay time 240 sec
Measuring Time 60 sec
Ref value 0-25 IU/L
High Linearity 1000 IU/L
Factor 8360

6.3.2 Assay Procedure: Carry out the testing as per below table.
6.3.2.1 Table:
Reagent Control/Sample
Reagent R1 800 µL
Reagent R2 200 µl
Sample 40 µL
6.3.2.2 Mix and aspirate the sample /Control test .The result of the sample /Control obtained
after the completion of the test Control values printed in the Value sheet of control being used e.g.
(Randox 2, Randox 3, Biorad 1, Biorad 2 etc….).
Note: Mix next sample after first sample result out within 120 seconds.
7.0 RECORDS/ FORMAT

IP / FG TEST REPPORT FORMATS.

8.0 ABBREVIATIONS

SOP - Standard Operating Procedure

SN- Screw neck

9.0 CHANGE HISTORY DETAILS

Superseded Document No.
Change control no. Change details
and revision status

N/A N/A

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 BIOLINE DIAGNOSTICS LLP
H, 1478 DSIDC Industrial area, Narela, Delhi, 110040
STANDARD OPERATING PROCEDURE
Doc. No. QC/PSTP/009 3 /3
Doc. Name STP for CK-MB Revision No.

Effective Date Next Review

New initiation

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