ANNEX 2 – TESTING REPORT FORMAT FOR LOT VERIFICATION TESTING
1. General information about the lot testing event
Date tests received
dd/mm/yyyy
Test date
dd/mm/yyyy
Product name
[add]
Distributor/imp
orter name
and address
[add]
Product code
[add product code]
Expiry date
dd/mm/yyyy
Lot number
[add]
Pre-distribution lot testing [tick one]
Post-distribution lot testing [tick one]
Laboratory performing the testing
[name of testing laboratory]
Site test kits were sampled from
[add site name]
Report number
[add report number assigned by testing laboratory]
Report date
dd/mm/yyyy
Responsible person
[add name]
2. Introduction
The objective of lot testing is to verify the performance of the IVD and to ensure that it continues to meet WHO
requirements for prequalification54 by identifying any form of product failure.
3. Materials and method
The lot testing verification panel of well-characterized specimens constituted of the following specimens. The
specimens were characterized with [state test kit name and manufacturer name].
Testing objective
Specimen details
Total
Anti-HIV-1 analytical
sensitivity
4 HIV-1 specimens 2-fold dilutions (first non-reactive and last two
reactive specimens)
12x3
Anti-HIV-2 analytical
sensitivity
1 HIV-2 specimen 2-fold dilutions (first non-reactive and last two
reactive specimens)
3x 3
Sensitivity
2 (undiluted) HIV low seropositive specimens
2
Specificity
3 seronegative specimens
3
Grand total
50
The IVD was performed exactly according to manufacturer’s instructions for use. For rapid diagnostic tests and
other subjectively read assays, the band intensity was scored.
54 Or continues to meet the initial performance criteria for pre-market assessment for non-WHO-prequalified IVDs.
1
POST-MARKET SURVEILLANCE OF IN VITRO DIAGNOSTICS
POST-MARKET SURVEILLANCE OF IN
VITRO DIAGNOSTICS
4. Results and analysis
The evaluation results were interpreted by two technicians, recorded in a standardized data collection worksheet.
These data were then transcribed into this lot testing report.
Test results
Panel Specimen ID
Reading 1
Series 1,
Dilution 1
Series 1,
Dilution 1
Series 1,
Dilution 1
Series 1,
Dilution 2
Series 1,
Dilution 2
Series 1,
Dilution 2
Series 1,
Dilution 3
Series 1,
Dilution 3
Series 1,
Dilution 3
Series 2,
Dilution 1
Series 2,
Dilution 1
Series 2,
Dilution 1
Series 2,
Dilution 2
Series 2,
Dilution 2
Series 2,
Dilution 2
Series 2,
Dilution 3
Series 2,
Dilution 3
Series 2,
Dilution 3
Series 3,
Dilution 1
Series 3,
Dilution 1
Series 3,
Dilution 1
Series 3,
Dilution 2
Series 3,
Dilution 2
2
POST-MARKET SURVEILLANCE OF IN VITRO DIAGNOSTICS
Reading 2
Lot testing result
Reference result
POST-MARKET SURVEILLANCE OF IN
VITRO DIAGNOSTICS
Test results
Panel Specimen ID
Reading 1
Series 3,
Dilution 2
Series 3,
Dilution 3
Series 3,
Dilution 3
Series 3,
Dilution 3
Series 4,
Dilution 1
Series 4,
Dilution 1
Series 4,
Dilution 1
Series 4,
Dilution 2
Series 4,
Dilution 2
Series 4,
Dilution 2
Series 4,
Dilution 3
Series 4,
Dilution 3
Series 4,
Dilution 3
Series 5,
Dilution 1
Series 5,
Dilution 1
Series 5,
Dilution 1
Series 5,
Dilution 2
Series 5,
Dilution 2
Series 5,
Dilution 2
Series 5,
Dilution 3
Series 5,
Dilution 3
Series 5,
Dilution 3
HIV +
HIV +
HIV HIV HIV -
3
POST-MARKET SURVEILLANCE OF IN VITRO DIAGNOSTICS
Reading 2
Lot testing result
Reference result
POST-MARKET SURVEILLANCE OF IN
VITRO DIAGNOSTICS
5. Acceptance criteria
Specimen type
Acceptance criteria for RDTs
4x HIV-1 dilution series
All triplicates to be concordant for each specimen. First non-reactive
specimen to be non-reactive, last reactive specimen to be reactive.
1x HIV-2 dilution series
All triplicates to be concordant for each specimen. First non-reactive
specimen to be non-reactive, last reactive specimen to be reactive.
2x HIV seropositive specimens
Both specimens to be reactive.
3x HIV seronegative specimens
All three specimens to be non-reactive.
Lot testing specimens
Lot number [add lot number]
HIV-1 dilution series #1
[Pass/Fail]
HIV-1 dilution series #2
[Pass/Fail]
HIV-1 dilution series #3
[Pass/Fail]
HIV-1 dilution series #4
[Pass/Fail]
HIV-2 dilution series
[Pass/Fail]
Undiluted HIV seropositives
[Pass/Fail]
HIV seronegatives
[Pass/Fail]
6. Conclusion
Lot number [add] of [add assay name] with expiry date [add] was tested on [dd/mm/yyyy]. The results showed that
this lot produced acceptable results for the lot verification testing panel. Any unexpected outcomes, e. g. instability
of reagent, defects, software errors etc. as well as any deviation from the defined procedures shall be properly
recorded and be part of the evaluation report.
4
POST-MARKET SURVEILLANCE OF IN VITRO DIAGNOSTICS