BIOLINE DIAGNOSTICS LLP

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

STANDARD TESTING PROCEDURE
Doc. No. QC/STP/005/014 1 /3
Doc. Name STP for Glucose (IP) Revision No.

Effective Date Next Review

1.0 Objective:
To the describe procedure for In-process testing of Glucose.

2.0 SCOPE
This STP is applicable for the In- process testing of Glucose.

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
QC/SOP/022: SOP for STP
6.0[5.0] PROCEDURE
6.1 Visual Check:
6.1.1 Reagent color: Take 1 ml of Glucose 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 to slightly pink.
Standard: Should be clear transparent.
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.
6.2.1 Set Parameter: Set the below parameter in biochemistry analyzer before carrying out the
test:
Name of Test Glucose
Mode End point

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 BIOLINE DIAGNOSTICS LLP
H, 1478 DSIDC Industrial area, Narela, Delhi, 110040
STANDARD TESTING PROCEDURE
Doc. No. QC/STP/005/014 2 /3
Doc. Name STP for Glucose (IP) Revision No.

Effective Date Next Review

Filter 505 nm
Reaction direction Increasing
Temperature 37⁰C
Incubation time 10 min
Ref value 70-105 mg/dl
High Linearity 500 mg/dl
Standard conc. 100 mg/dl
Blank Type Reagent
6.2.2 Assay Procedure:
6.2.2.1 Standard assay: Carry out the standard testing as per below table.
6.2.2.2 Table
Assay Blank Approved Standard/ Reference Under Test
Calibrator (4 test tube each 1 Standard (4 test tube each 1
ml) ml)
Reagent R1 1ml 1ml 1ml
Standard NA 10µl 10µl
6.2.2.3 Mix all the tubes and incubate for 10 min at 37⁰C. After completion of incubation time
take the absorbance of Approved Standard/Reference Calibrator and Under Test Standard
against the Reagent blank. Reagent blank should not be more than 0.300 OD
Calculate the Concentration of Under test Standard using the below formula

Conc of U/T STD = Abs of App STD /Ref Cal- Abs of Rgt blank x Abs of U/T STD /Ref
Cal- Abs of Rgt blank
Conc of App STD/Ref Cal
The concentration of Under test standard should fall within the acceptable limit of the
standard concentration (99-101)
6.2.2.2 Validation of standard using Quality control/Sample and Linearity samples

Once the Under test standard is Approved against previously QC passed standard/Reference
calibrator we need to validate it against third part control or reference lab samples as below
table.

6.2.2.3 Assay table

Reagent Blank Standard Control/Sample High Linearity

Prepared by: Reviewed by: Approved by:

 BIOLINE DIAGNOSTICS LLP
H, 1478 DSIDC Industrial area, Narela, Delhi, 110040
STANDARD TESTING PROCEDURE
Doc. No. QC/STP/005/014 3 /3
Doc. Name STP for Glucose (IP) Revision No.

Effective Date Next Review

Reagent R1 1ml 1ml 1ml 1ml
Standard NA 10µl NA NA
Control/ Sample NA NA 10 µl NA
High Linearity N/A NA NA As per need
6.2.3 Read the absorbance of Standard, Control/Sample, and High linearity tubes against the
Reagent blank at 37⁰C, the reagent blank should not exceed 0.300 OD. There should not
be any significant increase in the absorbance of the reagent.
6.2.5 The result of Control, High linearity obtained after the completion of the test should
fall within the acceptable limit of the Control values printed in the Value sheet of control being
used e.g. (Randox 2, Randox 3, Biorad 1, Biorad 2 etc….) and high linearity should also within
acceptable range
6.3 Prepare Analysis report
6.3.1 After complete the In process testing analysis report should be prepared by the responsible
person and released IP reagent as per In process SOP (QC/SOP/005).

7.0 RECORDS/ FORMAT

IP TEST REPPORT FORMATS-QC/IHS/005//014

8.0 ABBREVIATIONS

SOP - Standard Operating Procedure

STP - Standard Testing Procedure

H.L - High Linearity

IP - In process

9.0 CHANGE HISTORY DETAILS

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

New initiation N/A N/A

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