Attachment 3e_HIV RT EZ Entry Instructions

Attachment 3e_HIV RT EZ Entry Instructions.doc

Performance Evaluation Program for Rapid HIV Testing

Attachment 3e_HIV RT EZ Entry Instructions

OMB: 0920-0595

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HIV RT MPEP ONLINE SURVEY INSTRUCTIONS

Updated May 1, 2009



NOTE: Test procedures on these samples should be performed in the same manner as test procedures used for patient specimens.


General Information for Entering and Editing Your

HIV Rapid Testing Results Online




  • IMPORTANT: Please Do Not submit the paper worksheet for the EZ form!!!

We are only accepting results online.

  • DO NOT submit multiple online forms for the same type of rapid testing kit.

  • If you use more than one type of rapid testing kit to test the current MPEP sample panel, fill out a new online form for each different type of rapid testing kit.


  • After completing each page (screen) either click on the “submit” or “continue” buttons at the bottom of the screen, or hit the “Enter” button on your keyboard.

  • For security purposes, each time you log in you will have 60 minutes to enter your data before your session is automatically terminated. You must have submitted your current page and have no unresolved error messages in order for your current data to be automatically saved.


  • This online data entry program is interactive, and designed to help you avoid entering incorrect or incompatible data. If an error is detected, an error message will appear at the top of the current screen. You may click on the error message to be directed to the location of the error.


  • Within the time limit of each data entry session, you may use the “back” button of your Internet browser to return to a previous page and make corrections in your entered data.


  • You may login as many times as you wish, up until the deadline for submission of survey data. These deadlines are given for each survey on the bottom of the first data entry screen.


  • We strongly recommend that you use the “print” option after submitting the completed survey to check your results for any errors. There will be a link to the printable page after your results have been successfully submitted.


  • You may edit any completed survey at any time prior to the submission deadline by logging in again and choosing the survey you desire to edit.


S pecific Directions For Entering HIV Rapid Testing Results


Question 1.Rapid HIV test kit used in testing the Performance Sample Panel”

Enter the Manufacturer and HIV Rapid Test Kit Name, by choosing the one appropriate to the procedure used. Choices are provided in the drop down menu under question#1. For specific manufacturer test kits not listed, please choose the “Other” option and specify the manufacturer and the name of the test kit in the space provided.


Enter the Lot number of the kit used, which should be provided by the Manufacturer


Enter the Test Kit Version, if this information is supplied by the Manufacturer.


Question 2. For the rapid HIV test kit listed above, please indicate:

a) the specimen type(s) normally tested in your facility (check all that apply).

Check the box next to each sample type that your facility normally runs.


You may choose multiple types, if this is appropriate for the testing practices of your facility. If a specimen type is not listed, please check the “other” box and fill in the blank with a description of the specimen type.


b) for what purpose do you use the above HIV rapid test kit.

Check the box next to the reasons for which the HIV rapid tests are performed.

If HIV rapid testing is performed only for patients/clients or for determining if whether or not the source patient of an employee’s exposure to body fluids/materials is HIV positive, then only check “HIV initial testing”.



Question 3. PERFORMANCE PANEL RESULTS


NOTE: Sample panels consist of six samples. Within the panel, all information for each sample will be recorded on one horizontal line.

For “Date of testing”: click on the “Choose Date” link and select the date that you tested

the current MPEP HIV rapid testing PE samples.


For the column “SAMPLE CODE”:

Please verify that the letter/number code corresponds to the labels printed on each of the sample vials you received in your sample panel.

Two character Sample codes are printed on each vial. If there is a discrepancy between the codes printed on your sample vials and the codes provided on the online results screen, please contact the HIV-RT Project Coordinator at: ph 404-498-2246, email LVaughan@cdc.gov or the MPEP at 1-877-360-8502.


For the column “FINAL RESULT/INTERPRETATION”:

Please select from the drop down menu to answer for each sample.



Question 3. PERFORMANCE PANEL RESULTS, continued


For the column “COMMENTS” :

If commentary about a sample result is necessary, please include text of up to

100 characters in the space provided.

DO NOT USE THIS “Comments” SECTION TO GIVE THE TESTING RESULT OR INTERPRETATION!!!!


Question 4. For the rapid HIV test kit you specified in question#1, what confirmatory

test(s) does your facility require to confirm a preliminary positive (REACTIVE)

result?


NOTE: This question is meant to collect information regarding where

confirmatory testing is performed, not just where the confirmatory specimen was

acquired. If you collect a specimen at your facility but send this specimen out to

get the results, you should check an option in the 2nd (right-hand) column.


This question refers to your facility’s usual testing protocol for specimens

tested in your facility using the HIV Rapid Testing kit specified in question#1.


Confirmatory testing is HIV testing that is done AFTER the first rapid HIV

test kit result has been determined.


If your facility does NOT require such testing to be done prior to reporting a preliminary positive (REACTIVE) test result, check the box:

“No confirmatory testing required”


Otherwise, choose from the options provided. If your facility’s confirmation

requirements are not among the options, select “other” and describe in the

space provided (up to 100 characters are allowed).
























Question 5. For the kit specified in question#1:

does your facility normally run Quality Control (QC) samples

(positive and/or negative) when performing HIV rapid testing?


If your facility tests samples of known HIV status --positive/reactive or

negative/non-reactive--- according to a predetermined schedule of time or circumstances--- then your facility “normally” runs Quality Control (QC) samples and you should check the “yes” box.


Otherwise, check the “no” box.


If you checked “yes”, then please give information for each of the following

sections, by checking the appropriate boxes:

Section1: Please Indicate the Source(s) of Your

Quality Control (QC) Material(s):

In this section please indicate from where your Quality

Control Materials (positive and/or negative) came (i.e. the “source”). For

example, this could be either the company from which you purchased

your QC material, or your own facility if you make your own QC

material at your laboratory (i.e. QC prepared in-house)


Section2: Description of your Control (QC) Material

In this section please indicate, from the dropdown menu, the type of

material (i.e. of what substance the QC sample is made) that describes

your QC material. If your material is not listed, choose “other” and

specify the type of “other” QC material in the space provided. If you do

not know what type of material, select “other” and specify “Unknown” in

the space provided.


Section3: Frequency of Use of Control (QC) Material (Check ALL that apply)

In this section please indicate how often your facility runs

QC material by checking the appropriate box(es). You may

check more than one option.






If you need assistance in completing or submitting the online form, please contact

the MPEP at: 877-360-8502, or

the HIV RT MPEP Project Coordinator at: ph 404-498-2246, email LVaughan@cdc.gov

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File Typeapplication/msword
File TitleSURVEY INSTRUCTIONS
Authorzer3
Last Modified Byaeo1
File Modified2009-11-09
File Created2009-11-09

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