HIV-1 Antibody Result Form - Cover Letter

D EPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service

Centers for Disease Control

and Prevention (CDC)

Atlanta GA 30333

January 9, 2007

Shipment Letter for HIV-1 Antibody Testing

Model Performance Evaluation Program:

Testing for Human Immunodeficiency Virus Type 1 Antibody

Purpose

The purpose of this letter is to inform you that the six enclosed samples are provided as part of the CDC Model Performance Evaluation Program (MPEP) in which you have volunteered to participate.

Warning!

Carefully observe the WARNING on the front page of the result booklet.

Who should test these samples?

These samples should be tested by laboratories that perform traditional HIV-1 antibody tests such as: Enzyme immunoassay (EIA), Western blot (WB), Immunofluorescence assay (IFA), and “Other” test procedures, which do not fit neatly into the EIA WB and IFA category. Note: Process and test these samples in the same manner as patient specimens.

Who should NOT test these samples?

Do not test these samples if you perform only rapid testing, or if you no longer perform HIV testing. Contact: Daline Derival, Constella Group at 1-800-642-6941 or email: dderival@constellagroup.com

Damaged samples?

If you received damaged samples, you may request a second shipment by calling: MPEP Coordinator at ZeptoMetrix Corporation, at (508) 520-0588. Deadline: The deadline for requesting this second shipment is January 30, 2007.

Continued on the back

Shipment Letter for HIV-1 Antibody Testing, Continued

Reporting your results

There are 2 ways to report your test results: Online at: https://www.phppo.cdc.gov/MPEP/Results/login.asp using your password which was mailed to you December 28, 2006 or Mail the completed result booklet using the enclosed envelope. Note: Do not use both methods. Please choose only one method for submitting your results.

Online entries

If you misplaced your letter containing the password, or if you have difficulty submitting results online, call Sandra Neal at (404) 718-1006.

Deadline for submissions

February 16, 2007 is the deadline for mailing booklets and for online submissions.

Preliminary report

Within thirty (30) days after the above deadline, you will receive a preliminary report consisting of ● donor sample identification, and ● CDC testing results.

Final Report

When all participant laboratory results are compiled and evaluated, we will send you a detailed report. You can also access the final report online at: http://www.phppo.cdc.gov/mpep/hiv-1.aspx

Need additional information?

If you need additional information, contact: Sandra Neal, CDC, at (404) 718-1006.

Thank you!

We appreciate your participation in the Model Performance Evaluation Program.

Sandra W. Neal, B.S., MT (ASCP), M.S.

HIV-1 Project Coordinator

Centers for Disease Control and Prevention

Model Performance Evaluation Program

Laboratory Practice Evaluation and Genomics Branch Division of Laboratory Systems, Mailstop G-23

D EPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service

Centers for Disease Control

and Prevention (CDC)

Atlanta GA 30333

January 23, 2007

Shipment Letter for HIV-1 Antibody Testing

Model Performance Evaluation Program:

Testing for Human Immunodeficiency Virus Type 1 Antibody

Purpose

The purpose of this letter is to inform you that the six enclosed samples are provided as part of the CDC Model Performance Evaluation Program (MPEP) in which you have volunteered to participate.

Warning!

Carefully observe the WARNING on the front page of the result booklet.

Who should test these samples?

These samples should be tested by laboratories that perform traditional HIV-1 antibody tests such as: Enzyme immunoassay (EIA), Western blot (WB), Immunofluorescence assay (IFA), and “Other” test procedures, which do not fit neatly into the EIA WB and IFA category. Note: Process and test these samples in the same manner as patient specimens.

Who should NOT test these samples?

Do not test these samples if you perform only rapid testing, or if you no longer perform HIV testing. Contact: Daline Derival, Constella Group at 1-800-642-6941 or email: dderival@constellagroup.com

Damaged samples?

If you received damaged samples, you may request a second shipment by calling: MPEP Coordinator at ZeptoMetrix Corporation, at (508) 520-0588. Deadline: The deadline for requesting this second shipment is January 30, 2007.

Continued on the back

Shipment Letter for HIV-1 Antibody Testing, Continued

Reporting your results

There are 2 ways to report your test results: 1. Online at: https://www.phppo.cdc.gov/MPEP/Results/login.asp using your password which was mailed to you December 28, 2006 or 2. Mail the completed result booklet using the enclosed envelope. Note: Do not use both methods. Please choose only one method for submitting your results.

Online entries

If you misplaced your letter containing the password, or if you have difficulty submitting results online, call Sandra Neal at (404) 718-1006.

Deadline for submissions

February 16, 2007 is the deadline for mailing booklets and for online submissions.

Preliminary report

Within thirty (30) days after the above deadline, you will receive a preliminary report consisting of ● donor sample identification, and ● CDC testing results.

Final Report

When all participant laboratory results are compiled and evaluated, we will send you a detailed report. You can also access the final report online at: http://www.phppo.cdc.gov/mpep/hiv-1.aspx

Need additional information?

If you need additional information, contact: Sandra Neal, CDC, at (404) 718-1006.

Thank you!

We appreciate your participation in the Model Performance Evaluation Program.

Sandra W. Neal, B.S., MT (ASCP), M.S.

HIV-1 Project Coordinator

Centers for Disease Control and Prevention

Model Performance Evaluation Program

Laboratory Practice Evaluation and Genomics Branch Division of Laboratory Systems, Mailstop G-23