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CHOLESTEROL

This standard operating procedure describes the procedure for testing cholesterol levels. It outlines the responsibilities of quality control and quality assurance officers. The procedure involves visual checks of reagents, setting analyzer parameters, and running a blank, standard, and samples. Reagents and standard solutions are checked for color and clarity. The analyzer is set to specific parameters for the cholesterol test. A blank, standard, and samples are run to ensure results fall within acceptable ranges. Records of the test reports are maintained.

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28 views

CHOLESTEROL

This standard operating procedure describes the procedure for testing cholesterol levels. It outlines the responsibilities of quality control and quality assurance officers. The procedure involves visual checks of reagents, setting analyzer parameters, and running a blank, standard, and samples. Reagents and standard solutions are checked for color and clarity. The analyzer is set to specific parameters for the cholesterol test. A blank, standard, and samples are run to ensure results fall within acceptable ranges. Records of the test reports are maintained.

Uploaded by

sharmashyamsingh
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as DOCX, PDF, TXT or read online on Scribd
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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 Cholesterol Revision No.

Effective Date Next Review

1.0 Objective:
To the describe procedure for testing of cholesterol.

2.0 SCOPE
This STP is applicable for the testing of cholesterol.

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, Standard reagent bottle color according to the pack
configuration file. It shall be,
R1: SN Brown plastic bottle with cap
Standard: SN clear glass vials with plastic caps & plugs.
6.1.2 Reagent color: Take 1 ml of Cholesterol reagent R1, standard 200 micro liter in a clear
glass test tube and examine under bright light for any turbidity or suspended particles.
R1: Should be clear transparent colorless solution generates foam on shaking.
Standard: Should be clear colorless solution generates foam on shaking.
6.2 Testing procedure: Before performing the test, bring the reagents R1 and Standard at
room temperature. Testing is to be done with biochemistry analyzer (sop).

Prepared by: Reviewed by: Approved by:


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 Cholesterol Revision No.

Effective Date Next Review


6.3.1 Set Parameter: Set the below parameter in biochemistry analyzer before carrying out the
test:
Mode- End point
Filter 505 nm
Reaction direction Increasing
Temperature 37⁰C
Incubation time 5 min
Ref value 200-239 mg/dl
High Linearity 1000 mg/dl
Standard conc. 200 mg/dl

6.3.2 Assay Procedure: Carry out the testing as per below table.
6.3.2.1 Table:
Reagent Blank Standard Control/Sample
Reagent R1 1ml 1ml 1ml
Standard NA 10 µl NA
Control/ Sample NA NA 10 µl
6.3.2.2 Mix and aspirate the blank reagent after 5 min incubation at 37 ˚C observe the
starting absorbance of the reagent, Starting Absorbance of the reagent blank should not
exceed 0.050 OD. There should not be any significant increase in the absorbance of the
reagent. Final Absorbance after the completion of the test should not be more than 0.050
OD.
6.3.2.3 Mix and aspirate the standard, sample /Control after 5 min incubation at 37 ˚C test,
the result of the standard, sample /Control obtained after the completion of the test should
fall within the acceptable limit of the standard (199-201), 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

Prepared by: Reviewed by: Approved by:


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 Cholesterol Revision No.

Effective Date Next Review

9.0 CHANGE HISTORY DETAILS


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

N/A N/A
New initiation

Prepared by: Reviewed by: Approved by:

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