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 Bilirubin T&D Revision No.

Effective Date Next Review

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

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

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, R3 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
R3: SN White plastic bottle with cap
6.1.2 Reagent color: Take 1ml of Bilirubin reagent R1, R2, R3 in a clear glass test tube and
examine under bright light for any turbidity or suspended particles.
R1: Should be clear transparent colorless with foam .
R2: Should be clear transparent colorless.

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 Bilirubin T&D Revision No.

Effective Date Next Review

R3: Should be clear transparent colorless.
6.2 Testing procedure: Before performing the test, bring the reagents R1 , R2 ,R3 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:
Mode- End point
Filter 546 nm
Secondary filter 670/630 nm
Reaction direction Increasing/positive
Temperature 37⁰C
Incubation time 5 min
Ref value 0.2-1.2mg/dl
High Linearity 20mg/dl
Factor total 21/24
Factor direct 12/17
6.3.2 Assay Procedure: Carry out the testing as per below table.
6.3.2.1 Table:
Reagent Control/Sample
Bilirubin total 1ml
(TR1)
T&D R2 20 µl
Control/ Sample 50µl
Procedure for Direct Bilirubin
Rrr Bilirubin direct 1ml
(DR1)
T&D R2 10 µl

Control/ Sample 50µl

6.3.2.2 Mix and aspirate the sample /Control after 5 min incubation at 37 ˚C . the result of the
standard, 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
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 Bilirubin T&D Revision No.

Effective Date Next Review

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
New initiation

Prepared by: Reviewed by: Approved by: