Quality assurance for Dengue IgM antibodies in the Serum samples

PURPOSE: This SOP explains the procedure for carrying out quality assurance for the tests performed for Dengue IgM Antibody testing.

2. STAFF RESPONSIBLE AND AUTHORIZED TO PERFORM THE PROCEDURE: Technical and Doctor staff

3. PRINCIPLE OF PROCEDURE USED FOR EXAMINATION – Not applicable

4. PROCEDURE

1. Internal quality control
2. External quality control and Interlaboratory control testing

INTERNAL QUALITY CONTROL

1. Refer SOP no 4.3, Page no. 20.

EXTERNAL QUALITY CONTROL AND INTERLABORATORY CONTROL TESTING

1. Every 6 months one positive and one negative sample are sent to Green cross pathology laboratory for Dengue, which is NABL accredited lab for external quality control.
2. Results from the green cross lab are received, results are compared with our lab results and entered in the External quality control register no. DR 11 and DF 14 ‘EQAS file’.

5. PERFORMANCE SPECIFICATION – Results of QC samples should conform to previous values.

6. VALIDATION OF RESULTS TO BE DONE BY – Section Incharge

7. REVIEW, RECORDS, REMARKS AND RECOMMENDATION

Samples used as Quality Control are entered in Quality Control register no DR 11 after assigning QC no & their results of each run also documented.

·       DR 11– Internal QC / EQAS Register