世界卫生组织(WHO)对HIV血清学检测实验室评估标准

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Diagnostics and Laboratory Technology Prequalification of Diagnostics WHO PROTOCOL for the laboratory evaluation of HIV serology assays PQDx_030. Version: 1.0

Table of Contents

1.Introduction (2)

1.1.Prequalification of diagnostics (2)

1.2.WHO laboratory evaluation of diagnostics for HIV antibody and/or antigen detection (2)

2.Study objectives (3)

2.1.Overall objectives (3)

2.2.Specific objectives (3)

3.Study Design (3)

3.1.Reference laboratory (3)

3.2.Training, performance evaluation and supervision (4)

3.3.Safety (4)

3.4.Storage of assays (4)

4.Specimens (5)

4.1.WHO HIV specimen reference panel (5)

4.2.Batch-to-batch variation panel (8)

4.3.HIV seroconversion panels (8)

4.4.HIV performance panels (8)

4.5.WHO international reference preparations (8)

4.6.HIV culture supernatant panel (8)

4.7.External quality control specimen (8)

boratory testing (9)

5.1.Sequence of testing (9)

5.2.Recording test results (9)

6.Quality control and interpretation of test results (10)

6.1.Test kit controls (10)

6.2.Internal control lines for rapid test devices (10)

6.3.External quality control specimen (10)

6.4.Proficiency panels (10)

6.5.Limits of acceptability (11)

6.6.Interpretation of results (11)

7.Analysis of data (11)

7.1.Invalid runs/devices (11)

7.2.Inter-reader variability (11)

7.3.Performance characteristics from WHO specimen reference panel (11)

7.4.Interpretation of results from batch-to-batch variation panel (13)

7.5.Interpretation of seroconversion sensitivity (13)

7.6.Interpretation of results from performance panels (13)

7.7.Interpretation of results from WHO international reference preparation (14)

7.8.Interpretation of results from culture supernatant panel (14)

7.9.Discrepant results (14)

7.10.T echnician's appraisal (14)

7.11.R eport preparation (14)

8.Materials and supplies (15)

8.1.Data collection sheets (15)

8.2.Supplies (15)

9.Roles and responsibilities (15)

9.1.Responsibilities of ITM (15)

9.2.Responsibilities of WHO/DLT (15)

10.References (16)

11.Other documents required (16)

1. Introduction

1.1. Prequalification of diagnostics

The World Health Organization (WHO) Prequalification of Diagnostics programme is coordinated through the Diagnostics and Laboratory Technology team (DLT), in the department of Essential Health Technologies (EHT). The aim of the WHO Prequalification of Diagnostics programme is to promote and facilitate access to safe, appropriate and affordable diagnostics of good quality in an equitable manner. Focus is placed on products for high burden diseases and their suitability for use in resource-limited settings. The WHO prequalification of diagnostics process includes three main components: •review of an application form and product dossier;

•laboratory evaluation of the product;

•inspection of the manufacturing site(s).

This document pertains to the objectives and processes of the laboratory evaluation component of the prequalification assessment. This document intends to provide information for manufacturers on the process for laboratory evaluation.

1.2. WHO laboratory evaluation of diagnostics for HIV antibody and/or antigen

detection

The laboratory evaluation determines the accuracy of HIV assays in comparison with established performance criteria. These characteristics include: sensitivity, specificity, negative and positive predictive values as well as the accuracy. In addition, a number of operational characteristics are assessed including the suitability for use in laboratories and/or testing settings with limited infrastructure.

Assays for the detection of HIV antibody and assays for the detection of both HIV antibody and HIV antigen are covered in this protocol.

All HIV serology assays submitted for laboratory evaluation are assessed at the Institute of Tropical Medicine, Antwerp, Belgium (ITM) upon the instruction of WHO/DLT. The WHO

approximately 1062 serum/plasma specimens anti-HIV positive and anti-HIV negative specimens from Europe, Africa, Asia and Latin America plus several well-characterized commercial seroconversion panels and performance panels, a batch-to-batch variation panel, WHO international biological reference preparations and a culture supernatant panel (reserved for products that include detection of HIV antigen).