SMILE

JohnsHopkinsUniversity

Baltimore, MDUSA

HIV Immunoassay Validation Summary Template

Author:
Validation Committee / Document Number: / Equ35-G-03
Effective (or Post) Date: / 4 March 2011
Review History / Date of last review: / NA
Reviewed by: / Heidi Hanes
SMILE Comments: This document is provided as an example only. It must be revised to accurately reflect your lab’s specific processes and/or specific protocol requirements. Users are directed to countercheck facts when considering their use in other applications. If you have any questions contact SMILE.
HIV Immunoassay Validation Summary Template / Document Number / 1520
Effective Date / 1 June 2009
Subject
Template for summarizing results of validation of an HIV Immunoassay qualitative method / Page / 1 of 1
Supersedes / 1.0
Author(s) / Name, Title / Date
Mark Swartz, Heidi Hanes, Jo Shim, Penny Stevens, Anne Sholander / June 2009
Approved by / Name, Title / Date
SMILE Validation Committee / June 2009
Review History / Date of last review: / 1 June 2009
Reviewed by: / Anne Sholander
Revision History / Version # [0.0] / Revision Date [dd/mm/yy] / Description (notes)
1.1 / 2/15/2011 / Corrected terminology/calculation table for Diagnostic Sensitivity and Specificity. Updated Analytical Sensitivity and Analytical Specificity sections to no longer recommended excerpting package insert information.

HIV ImmunoassayValidation Summary Report

Purpose: Validation Re-Validation Other:

Description of Equipment/Process:

Equipment/Process: Insert test method/instrumentation (e.g. Abbott Murex HIV 1/2 EIA)

Insert description of assay from kit insert, e.g.:Enzyme immunoassay for the detection of antibodies to human immunodeficiency virus types 1 (HIV-1, HIV-1 group O) and 2 (HIV-2) in human serum or plasma

Serial Number: Insert instrument serial number

Location: Insert lab name and location

Date: Insert date(s) of validation

FDA Approval Status: ApprovedNot approved

Procedure:

Refer to the Insert lab nameValidation Plan for HIV Immunoassay.

Results: All raw data reports and statistical analysis can be found in theHIV Immunoassay validation binder.

  1. Precision- refer to tab A

Insert information from kit insert. See example below.

Site / Negative Control MFG %CV and OD / Lab Result % CV
Within Run / Lab Result % CV
Between Day / Acceptability
1 / 17.5% at 0.157 / 6.17% at mean of 0.293 / 12.37% at mean of 0.192 / Acceptable
2 / 6.7% at 0.115
3 / 6.8 at 0.125
Site / HIV-1 Positive Control MFG %CV and OD / Lab Result % CV
Within Run / Lab Result % CV
Between Day / Acceptability
1 / 17.3% at 1.465 / 1.63% at 3.585** / 5.51% at 2.004 / Acceptable
2 / 9.7% at 1.372
3 / 5.2% at 1.203

1520_SMILE HIV Immunoassay Validation Summary Template v.1.1.doc 1 of 4

SMILE

JohnsHopkinsUniversity

Baltimore, MDUSA

  1. Accuracy-refer to tab B

Method being Validated / Diagnostic Sensitivity and Specificity
(Results from Comparison Study) / Total
Positive / Negative
Positive / # true positive (TP) / # false positive (FP) / TP+FP
Negative / # false negative (FN) / # true negative (TN) / FN+TN
Total / TP+FN / FP+TN / N
  1. Diagnostic Sensitivity (True positive rate) = 100 x [TP/(TP+FN)]
  2. Diagnostic Specificity (True negative rate) = 100 x [TN/(FP+TN)]
  3. Percent Positive Agreement (Positive Predictive Value) =100 x TP/(TP+FP)
  4. Percent Negative Agreement (Negative Predictive Value) =100 x TN/(TN+FN)

Results / Lab Result (%) / Expected Result / Acceptability
Sensitivity=
100 x [TP/(TP+FN)] / Insert manufacturer’s claim (%)
Specificity=
100 x [TN/(FP+TN)] / Insert manufacturer’s claim (%)
Positive Agreement (Positive Predictive Value) =100 x TP/(TP+FP) / Insert manufacturer’s claim (%)
Negative Agreement (Negative Predictive Value)= 100 x TN/(TN+FN) / Insert manufacturer’s claim (%)
  1. Linearity and Reportable Range
  2. Linearity - Not applicable
  3. Reportable Range: Negative / Positive
  1. Analytical Sensitivity (lower limit of detection)-refer to test kit package insert. For FDA approved tests, manufacturer’s stated cut-off will be used.
  1. AnalyticalSpecificity (interfering substances) -refer to test kit package insert. For FDA approved tests, manufacturer’s claims of interfering substances will be used.
  1. Reference ranges/Expected results -refer to test kit package insert.

Normal= HIV Negative, Abnormal= HIV Positive

1520_SMILE HIV Immunoassay Validation Summary Template v.1.1.doc 1 of 4

SMILE

JohnsHopkinsUniversity

Baltimore, MDUSA

Method Approval

Approved / Not Approved

If not approved, provide recommendations/corrective actions below.

Laboratory Director: ______Date: ______

Insert lab director name

Prepared by: ______Date:______

Insert name and title

1520_SMILE HIV Immunoassay Validation Summary Template v.1.1.doc 1 of 4