Confirmatory Testing Algorithm. Routine Donor Testing Algorithm

Transcription

1 Confirmatory Testing Algorithm Blood Confirmatory ABO/Rh Beckman Coulter PK-ABO/Rh Immucor NEO ABO/Rh Immucor NEO ABO/Rh Immucor Manual ABO/Rh Typing Immucor Manual ABO/Rh Typing Discrepancy Resolution Immucor Manual ABO/Rh Resolution Antibody Screen Immucor NEO Capture-R Ready Screen-Pooled MTS gel 3-cell screen Ortho Antibody Identification ProVue Ortho Resolve Panel CMV Beckman Coulter PK-CMV PA Syphilis Beckman Coulter PK-TP Syphilis G EIA Captia If nonreactive, no further testing If reactive or equivocal, perform RPR RPR/Quantitative RPR Arlington Scientific (ASI) If nonreactive, no further testing If reactive, perform RPR titer

2 Blood Anti-HBC Anti-HCV T is Reactive Confirmatory If And Then dhcv T is Reactive T is Nonreactive dhcv T is Nonreactive or Not Tested No T Discrimination testing No further testing See further testing block. See further testing block. Anti-HCV EIA Alternate manufacturer Anti-HIV-1/2 If And Then dhiv T is Reactive No further testing. T is Reactive T is Nonreactive dhiv T is Non-reactive or Not Tested HIV-1 IFA performed (see below) HIV-1 IFA performed (see below). Anti-HIV-2 EIA Genetic Systems, Inc. If Non-reactive, no further testing. If Reactive, perform Geenius HIV-1/2 Supplemental Assay Licensed Anti-HIV-1 IFA Fluorognost If HIV-1 IFA is And Then NEG or IND See further testing block POS T is nonreactive Perform dhiv-1* Geenius HIV-1/2 Supplemental Assay No further testing *If dhiv-1 is nonreactive, perform Anti-HIV-1/2 Plus O retest on T tube to verify antibody reactivity. Blood Confirmatory

3 Blood Confirmatory HBsAg If And Then T is Reactive T is Non-reactive dhbv T is Reactive dhbv T is Nonreactive or Not Tested HBsAg Confirmatory Neutralization No further testing HBsAg Confirmatory Neutralization performed.(see below) HBsAg Confirmatory Neutralization performed (see below). If HBsAg Neutralization is Not confirmed Confirmed And T is nonreactive Then No additional testing Perform dhbv* *If dhbv is nonreactive, perform HBsAg retest on T tube to verify antigen reactivity. Anti-HTLV-I/II HTLV BLOT 2.4 WESTERN BLOT ASSAY MP Diagnostics N/A Anti-T. cruzi ESA Chagas Abbott

4 Supplemental or confirmation testing is performed to evaluate reactive screening assay results. This document highlights tests related to T testing for HIV-1, HCV R and HBV D only. Blood T Confirmatory Donor Testing Algorithm Confirmatory Whole Blood Donation T Test T Discrimination If T And Then antibody is No further T testing* T Alternate Manufacturer Serology retest Abbott Prism antibody is not See further testing block Does not Discriminate No further T testing HCT/P Product Sample (HCT/P Contract required for 2 nd Ultrio) T Test WNV T Test Grifols T Discrimination If T And Then Does not Discriminate antibody is antibody is not No further T testing* See further testing block 2 nd Grifols T test performed* T Alternate Manufacturer Serology retest Abbott Prism WNV T (Repeat test on original platform using alternate sample) WNV Antibody (IgM/IgG) ELISA Quest Diagnostics No further testing. *Refer to applicable antigen/antibody testing algorithm Referral testing turnaround time is routinely at least 1-2 weeks

5 Revision History Revision Implemented Reason 24 10/08/2017 Removed Roche T and WNV 23 07/17/2017 Clarified algorithm for ABO/Rh testing Discontinuation of HIV-2 Western Blot 22 12/19/2016 (replaced with Geenius HIV-1/2 Supplemental Assay) 21 07/01/2016 Discontinuation of Roche Ampliscreen PCR tests (replaced with Roche cobas TaqScreen MPX 2.0 assay) For reactive Anti-HCV, Anti-HIV-1/2 and/or HBsAg samples that are also MPX 2.0 reactive, confirmatory and supplemental testing will occur regardless of discriminatory T results Minor clerical and format edits Terminology change from supplemental testing to further testing 20 05/17/2016 Format changes Replacement of unlicensed HTLV and T. cruzi confirmatory tests with licensed assays 19 11/04/2014 Removal of T. Cruzi RIPA 18 06/02/2014 Updated Chicago lab to standard algorithm 17 02/03/ /03/ /06/ /29/2012 Updated for CTS Chicago Updated T. Cruzi reflex; added referral for alternate manufacturer T. Cruzi Updated HBsAg, HCV and HIV reflex for discriminatory NT s Updated HIV-1/2 table for T reactive/eia reactives. Updated HBsAg to remove variance requirement Updated HTLV I/II table to include information sheet requirement. Updated Syphilis table Updated T and WNV tables The addition of HCV screen under referral testing Removal for HCV RIBA references Added clarification about WNV 2nd test and HBsAg algorithm for clients with a variance 13 03/19/2012 Removed ChLIA, Abbott Prism, & EIA notations from assay names due to conversion to Ortho assays 12 08/02/2010 Updated T to add Ultrio testing 11 06/09/2010 Updated T to read

6 10 04/19/ /04/2010 Added HbsAg Variance line Added T HCT/P Sample line Removed assay for Anti HTLV I / HTLV II EIA assay no longer in use Changed Becton Dickinson to Arlington Scientific for RPR supplemental assay 08 06/01/2009 Updated to add 2nd Mx 07 02/17/2009 Updated EIA to ChLIA Abbott Prism 06 07/28/ /28/ /25/ /16/ /06/2007 Added new supplemental assay for HTLV I/II Inno-LIA HTLV I/II if HTLV-I/II EIA reactive Change Description HIV-1/HCV T Discrimination (d) to (dhiv-1 and dhcv) Removed Possible Interpretation column from HbsAg ChLIA table (relocated to Hepatitis Information section) Added PCR testing done for potential T yield donations Minor formatting changes Added Ortho MTS getl 3-cell Screen to Antibody Screen test Revised to remove Leishmania Antibody IFA test-this test has been discontinued Revised to remove introductory paragraph and reference to testing schedule Added Algorithim 01 04/16/2007 Added Anti-HIV-1/HIV-2 Plus O EIA Ortho Format Changes Added Revision History Initial Release 11/09/2006 Implemented for Website