Guidance for Industry 
 
Lookback for  
Hepatitis C Virus (HCV): 
Product Quarantine, Consignee 
Notification, Further Testing, Product 
Disposition, and Notification of 
Transfusion Recipients  
Based on Donor Test Results  
Indicating Infection with HCV 
 
 
 
 
Additional copies of this guidance are available from Office of Communication, Outreach and 
Development (OCOD) (HFM-40), 1401 Rockville Pike, Suite 200N, Rockville, MD 20852-
1448, or by calling 1-800-835-4709 or 301-827-1800, or email ocod@fda.hhs.gov, or from the 
Internet at 
http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guida
nces/default.htm. 
 
For questions on the content of this guidance, contact OCOD at the phone numbers listed above. 
 
 
 
 
 
U.S. Department of Health and Human Services 
Food and Drug Administration 
Center for Biologics Evaluation and Research (CBER) 
August 2007 
Updated December 2010   
Guidance for Industry 
 
Lookback for Hepatitis C Virus (HCV): 
Product Quarantine, Consignee Notification, 
Further Testing, Product Disposition, and 
Notification of Transfusion Recipients Based 
on Donor Test Results  
Indicating Infection with HCV 
 
 
 
NOTE:  Changes have been made to update the guidance dated August 2007: 
  Figure 1 and Table 1 of the guidance have been revised to reflect new technologies for 
anti-HCV testing, and corresponding changes have been made to the text.  
  The guidance has been updated to note that Title 21 Code of Federal Regulations 610.48 
(21 CFR 610.48) (historical lookback) requires blood establishments to have completed a 
number of actions by February 19, 2009, based on the review of historical testing records.  
Note that the recommendations for implementing historical lookback as reflected in 
Figures 2-4 and Tables 2-5 have been relocated to the new Appendix to this guidance.  
  In section IV, January 1, 1988 was revised to February 20, 2008. 
  The recommendation with respect to notification by transfusion services, as consignees, 
was expanded to include a recipients physician of record, as appropriate, consistent with 
the regulations.  
  The time frames in which blood establishments must perform appropriate procedures 
after a donor tests reactive for evidence of HCV infection were clarified. 
  A number of nonsubstantive changes were made throughout the document for 
clarification purposes. 
 
 
 
U.S. Department of Health and Human Services 
Food and Drug Administration 
Center for Biologics Evaluation and Research (CBER) 
August 2007 
Updated December 2010  Contains Nonbinding Recommendations 
Table of Contents 
 
I.     INTRODUCTION ............................................................................................................... 1 
II.  BACKGROUND ................................................................................................................. 2 
III.  DEFINITIONS .................................................................................................................... 4 
IV.  LOOKBACK REQUIREMENTS ..................................................................................... 5 
V.  CURRENT RECOMMENDATIONS ............................................................................... 6 
VI.  BLOOD AND BLOOD COMPONENTS INTENDED FOR MANUFACTURE INTO 
NON-INJECTABLE PRODUCTS .................................................................................. 7 
VII.  REFERENCES .................................................................................................................. 10 
APPENDIX .................................................................................................................................. 11 
 
  i  Contains Nonbinding Recommendations 
Guidance for Industry 
 
 Lookback for Hepatitis C Virus (HCV):   
Product Quarantine, Consignee Notification,  
Further Testing, Product Disposition, and  
Notification of Transfusion Recipients  
Based on Donor Test Results  
Indicating Infection with HCV  
 
 
This guidance represents the Food and Drug Administrations (FDAs) current thinking on this 
topic.  It does not create or confer any rights for or on any person and does not operate to bind 
FDA or the public.  You can use an alternative approach if the approach satisfies the 
requirements of the applicable statutes and regulations.  If you want to discuss an alternative 
approach, contact the appropriate FDA staff.  If you cannot identify the appropriate FDA staff, 
call the appropriate number listed on the title page of this guidance. 
 
 
I.  INTRODUCTION 
 
Multiple layers of safeguards, including donor screening and testing, are used to reduce the risk 
of transmitting infection through blood transfusion.  However, a person may donate blood early 
in infection, during the period when the viral marker is not detectable by a screening test, but the 
infectious agent is present in the donors blood (the window period).  For example, if an 
individual donates blood on a number of occasions and each donation tests nonreactive for 
antibody to HCV, but the donor returns and tests repeatedly reactive for antibody to HCV at a 
later date, prior collections from such a donor could be at increased risk for transmitting HCV.  
In addition, a recipient of a transfusion of blood or blood components collected during the 
window period from a donor who is now repeatedly reactive would not know that he or she 
might be at increased risk of infection with HCV through the transfusion, unless he or she is 
notified.  Furthermore, untested collections from donors who later were found to be repeatedly 
reactive when tested for antibodies to HCV since 1990 (when antibody tests for HCV became 
available) might have been at increased risk for transmitting HCV due to a chronic infection in 
the donor. 
 
Chronic hepatitis due to HCV is a major health problem in the U.S.  The infection is usually 
clinically silent until the liver is seriously damaged.  As a result, infected people usually are 
unaware of their disease.  Although transfusion-transmitted infections account for only a very 
small proportion of HCV infections, it is possible to identify and lookback at prior donations 
that might have been collected during the window period. 
 
  1  Contains Nonbinding Recommendations 
This guidance document provides recommendations for complying with 21 CFR 610.47 and  
21 CFR 610.481 to (1) blood establishments that collect blood or blood components, including 
Source Plasma and Source Leukocytes, (2) hospitals, and (3) other consignees.  This guidance 
does not apply to autologous donations, pooled blood components intended solely for further 
manufacturing into products that are manufactured using validated viral clearance procedures, 
and blood and blood components that were intended for manufacture into non-injectable products 
subject to the labeling described in Section VI. 
 
This document supersedes the guidance document of the same title, dated August 2007.  The 
August 2007 document superseded the HCV sections of the Food and Drug Administration 
(FDA) memorandum of July 19, 1996, entitled Recommendations for the Quarantine and 
Disposition of Units from Prior Collections from Donors with Repeatedly Reactive Screening 
Tests for Hepatitis B Virus (HBV), Hepatitis C Virus (HCV), and Human T-Lymphotropic Virus 
Type I (HTLV-I).  The August 2007 guidance document also superseded the September 1998 
guidance entitled Guidance for Industry:  Current Good Manufacturing Practice for Blood and 
Blood Components:  (1) Quarantine and Disposition of Units from Prior Collections from 
Donors with Repeatedly Reactive Screening Tests for Antibody to Hepatitis C Virus (Anti-
HCV); (2) Supplemental Testing, and the Notification of Consignees and Blood Recipients of 
Donor Test Results for Anti-HCV.  Additionally, the August 2007 guidance finalized FDAs 
draft guidance dated June 1999 entitled Guidance for Industry:  Current Good Manufacturing 
Practice for Blood and Blood Components:  (1) Quarantine and Disposition of Prior Collections 
from Donors with Repeatedly Reactive Screening Tests for Hepatitis C Virus (HCV); (2) 
Supplemental Testing, and the Notification of Consignees and Transfusion Recipients of Donor 
Test Results for Antibody to HCV (Anti-HCV).   
 
FDAs guidance documents, including this guidance, do not establish legally enforceable 
responsibilities.  Instead, guidances describe FDAs current thinking on a topic and should be 
viewed only as recommendations, unless specific regulatory or statutory requirements are cited.  
The use of the word should in FDAs guidances means that something is suggested or 
recommended, but not required.  
 
 
II.  BACKGROUND 
 
Lookback related to HCV testing has been discussed at open public meetings, including meetings 
of FDAs Blood Products Advisory Committee (BPAC), on multiple occasions since October 
1989.  As a response to these discussions, FDA provided detailed guidance in the July 19, 1996, 
memorandum on the quarantine and disposition of certain prior collections of blood and blood 
components from donors who subsequently test repeatedly reactive for anti-HCV.  The 1996 
memorandum recommended that blood establishments notify consignees (such as the transfusion 
service, physician, or fractionator) for the purpose of quarantine and eventual disposition of 
products made from prior collections.  Prior to recent advances in medical diagnosis and therapy, 
                                                           
1 Section 610.48 (21 CFR 610.48) requires blood establishments to have completed a number of actions by February 
19, 2009, based on the review of historical testing records.  Recommendations for implementing historical lookback 
required under 21 CFR 610.48 are included in Figures 2-4 and Tables 2-5, located in the Appendix. 
  2  Contains Nonbinding Recommendations 
FDA did not recommend notification of recipients of blood from donors who subsequently test 
positive for anti-HCV because no clear consensus on the public health benefit (i.e., disease 
prevention and treatment) of such action had emerged. 
 
Improvements in the management and treatment of chronic hepatitis C have occurred over time, 
and there is a strong correlation between a positive test for anti-HCV in a supplemental assay 
(e.g., the Chiron RIBA HCV 3.0 SIA2) and HCV infection (Refs. 1-4).  Prior collections from 
donors later found to be repeatedly reactive for anti-HCV might also be at increased risk of 
transmitting HCV. 
 
At public meetings on April 24 and 25, 1997, and August 11 and 12, 1997, the Public Health 
Service (PHS) Advisory Committee on Blood Safety and Availability recommended notification 
of recipients of transfused blood and blood components that are at increased risk of transmitting 
HCV infection based on donor screening with a licensed multiantigen screening test (Enzyme 
Immuno Assay (EIA) 2.0 or EIA 3.0) since 1992.  Consistent with these recommendations, in 
March 1998, FDA issued guidance for implementation and public comment regarding recipient 
notification (63 FR 13675, March 20, 1998).  In response to comments received, FDA issued a 
revised guidance for implementation in September 1998 (63 FR 56198, October 21, 1998). 
 
At public meetings on November 24, 1998, and January 28, 1999, the PHS Advisory Committee 
on Blood Safety and Availability reconsidered the issue of recipient notification related to 
repeatedly reactive results on the single antigen (EIA 1.0) screening test that was licensed in 
1990.  The PHS Advisory Committee recommended the expansion of the targeted HCV lookback 
program to include recipients of blood and blood components from donors subsequently 
identified as repeatedly reactive by the EIA 1.0 screening test.  In addition, the PHS Advisory 
Committee considered that, in cases where no supplemental test result is available, it is 
reasonable to perform lookback for EIA 1.0 based on a signal to cutoff ratio of the screening test 
of greater than 2.5 (S/CO > 2.5) to capture the vast majority of the true positives and minimize 
unnecessary recipient notifications based on false reactive screening test results.   
 
In accordance with the recommendations from the PHS Advisory Committee, FDA issued a draft 
guidance on HCV Lookback dated June 1999 for public comment (64 FR 33309, June 22, 1999) 
and published a proposed rule entitled Current Good Manufacturing Practice for Blood and 
Blood Components; Notification of Consignees and Transfusion Recipients Receiving Blood and 
Blood Components at Increased Risk of Transmitting HCV Infection (Lookback) (65 FR 
69378, November 16, 2000).  In the Federal Register of August 24, 2007, (72 FR 48766), FDA 
published the final rule entitled Current Good Manufacturing Practice for Blood and Blood 
Components; Notification of Consignees and Transfusion Recipients Receiving Blood and Blood 
Components at Increased Risk of Transmitting Hepatitis C Virus Infection (Lookback) and a 
companion guidance document, dated August 2007 (72 FR 48658).  The August 2007 guidance 
provided recommendations for complying with 21 CFR 610.47 and 21 CFR 610.48. 
 
                                                           
2 The Chiron Corporation (Emeryville, CA) RIBA HCV 3.0 SIA is a strip immunoblot assay based on recombinant 
antigens of HCV. 
  3  Contains Nonbinding Recommendations 
III.  DEFINITIONS 
 
Alternative Test:  A licensed test for anti-HCV that is of equal or greater sensitivity in 
comparison to the licensed HCV EIA 3.0. 
 
Blood and Blood Components:  Whole Blood and blood components, including Source Plasma 
and Source Leukocytes. 
 
Lookback:   
 
  The identification of blood and blood components from prior collections from a donor 
with: 
1.  a repeatedly reactive antibody screening test for anti-HCV; or 
2.  a reactive NAT3 for HCV; or  
3.  other reliable test results or information indicating evidence of HCV infection 
(provided the testing was performed using a test approved by FDA by a laboratory 
compliant with the Clinical Laboratory Improvement Amendments of 1988, or has 
met equivalent requirements as determined by the Centers for Medicare and Medicaid 
Services in accordance with the provisions of 42 CFR part 493); and 
  subsequent actions, such as: 
1.  quarantine of such blood and blood components that are not expired; 
2.  notification of consignees to quarantine such in-date blood products; 
3.  further testing of the donor;  
4.  destruction or relabeling of potentially infectious prior collections; 
5.  release from quarantine of blood and blood components that do not present a greater 
risk of infection; and (if appropriate)  
6.  notification of recipients of identified blood and blood components, or the recipients 
physician of record. 
 
Lookback Donations:  Collectively, the blood and blood components from prior collections 
from the same donor. 
 
Reactive NAT3 for HCV:  A result for an HCV RNA test that uses only one set of primers 
specific for HCV that is performed initially on an individual donation, or is performed as a 
discriminatory NAT subsequent to a reactive multiplex NAT, which tests for multiple viruses, 
including HCV RNA. 
                                                           
3 This guidance does not address testing, product disposition, donor management, and lookback for individual donor 
samples that test reactive on a multiplex NAT or a minipool that test reactive on a multiplex NAT.  In addition, 
under 21 CFR 610.47 and 610.48, lookback is required for individual donor samples that test reactive on a multiplex 
NAT but nonreactive for both HIV-1 and HCV when tested using discriminatory HIV-1 NAT and discriminatory 
HCV NAT.  See Guidance for Industry:  Nucleic Acid Testing (NAT) for Human Immunodeficiency Virus Type 1 
(HIV-1) and Hepatitis C Virus (HCV):  Testing, Product Disposition, and Donor Deferral and Reentry dated May 
2010, for FDA recommendations in these circumstances.  The document may be accessed at 
http://www.fda.gov/downloads/biologicsblood%20vaccines/guidancecomplianceregulatoryinformation/guidances/bl
ood/ucm210270.pdf accessed December 20, 2010. 
 
  4  Contains Nonbinding Recommendations 
 
Repeatedly Reactive Screening Test:  The result when an initially reactive screening test is 
repeated in duplicate samples on the same test run and one or both samples are reactive. 
 
NOTE:  In the HCV Lookback regulations, 21 CFR 610.47 and 610.48, we refer to screening 
tests as reactive instead of repeatedly reactive to accommodate the different testing 
algorithms established for NAT and other screening tests.  However, in this guidance we refer to 
reactive antibody screening test results for anti-HCV as repeatedly reactive to accurately reflect 
the established testing algorithm for anti-HCV. 
 
Transfusion Recipient Notification:  The actions taken by a hospital, transfusion service, or 
recipients physician of record to notify recipients that they received a transfusion of a Lookback 
Donation that is at increased risk of transmitting HCV infection. 
 
 
IV.  LOOKBACK REQUIREMENTS 
 
In this guidance, FDA addresses lookback related to donor screening by a licensed anti-HCV test 
and NAT.  Under 21 CFR 610.47 and 21 CFR 610.48, blood establishments must search records 
of prior collections from donors whose test results on current or historical review donations show 
evidence of infection with HCV (either repeatedly reactive on screening tests for anti-HCV or 
reactive on NAT for HCV RNA).  Blood establishments must search their records to identify 
prior collections dating back 10 years (for current donations) or dating back to January 1, 1988 
for historical review donations.  If an establishment maintains computerized electronic records 
relating to collections made before February 20, 2008, the blood establishment must perform a 
historical review search of those records dating back indefinitely, as far back as they exist in 
computerized, electronic form (21 CFR 610.48(b)(1)(i)).  The blood establishment must search 
records of prior collections, if available, back to the date 12 months prior to the donors most 
recent nonreactive licensed multiantigen screening test for anti-HCV (if applicable), if that is a 
shorter period, since prior infection in the donor is highly unlikely based on the known duration 
of the window period (see 21 CFR 610.47(a)(1)(i) and 21 CFR 610.48(b)(1)(iii)(A)).  FDA 
believes that this date (12 months prior to the last nonreactive multiantigen screening test for 
anti-HCV) will antedate the window period for infection in that donor. 
 
FDA believes that results for NAT are of value in (1) lookback related to current collections 
when a NAT result exists and (2) in historical lookback, when a NAT result, including NAT 
performed under an Investigational New Drug Application (IND), exists in the record of the 
previous donation(s).  Blood establishments should consider a reactive NAT result to be 
presumptive evidence of ongoing HCV infection.  A reactive NAT must serve as a basis for 
initiating lookback (i.e., both quarantine and recipient notification) (21 CFR 610.47(a)(1)).  Note 
that certain licensed HCV NAT have been labeled with a limited supplemental claim.  When 
current donor test results are repeatedly reactive on an anti-HCV screening test and reactive on 
HCV NAT, the reactive NAT acts as a positive supplemental test and it is not necessary to 
perform a licensed multiantigen supplemental test for anti-HCV.  However, a nonreactive NAT 
should not be a reason for not performing lookback for a donation that is repeatedly reactive on  
  5  Contains Nonbinding Recommendations 
an anti-HCV screening test.  This recommendation is based on current research that indicates that 
in about 15-25% of cases of HCV infection, viremia may be intermittently detectable (Ref. 5) or 
resolved (Ref. 6). 
 
Blood establishments must initiate lookback based on a reactive NAT although a screening test 
or supplemental test for antibodies to HCV performed on the same collection is nonreactive  
(21 CFR 610.47(a)(1)).  In this situation, blood establishments must search records of prior 
collections for the 12 months prior to the date of the NAT-reactive donation  
(21 CFR 610.47(a)(1)(ii) and 21 CFR 610.48(b)(1)(iii)(B)), since this configuration of test results 
is consistent with recent HCV infection in the donor (Ref. 7). 
 
Blood establishments that collect blood or blood components, including Source Plasma and 
Source Leukocytes, must establish, maintain and follow appropriate procedures4 for the 
following actions within specified timeframes after a donor tests reactive for evidence of HCV 
infection (21 CFR 610.47(a)); or during an historical record review, after identifying donors who 
tested reactive for evidence of HCV infection (21 CFR 610.48(b)): 
  quarantine prior collections that remain in inventory; 
  notify consignees to quarantine prior collections;  
  further test the donor and notify consignee of test results; and 
  destroy or relabel potentially infectious prior collections. 
 
Under 21 CFR 610.47(b) and 21 CFR 610.48(c), transfusion services, as consignees, must 
establish, maintain and follow an appropriate system for the following actions within specified 
timeframes, when notified by the collecting establishment: 
  quarantine prior collections that remain in inventory; 
  destroy or relabel potentially infectious prior collections; and 
  notify transfusion recipients who received blood or blood components from a donor 
who is later determined to be infected with HCV, if appropriate, or the recipients 
physician of record, as appropriate. 
 
NOTE:  Recommendations for implementing historical lookback required under 21 CFR 610.48 
are included in Figures 2-4 and Tables 2-5, located in the Appendix. 
 
 
V.  CURRENT RECOMMENDATIONS 
 
Current lookback recommendations are provided in Figure 1 and Table 1 to assist blood 
establishments in complying with the regulations in 21 CFR 610.47.  
 
 
                                                           
4 See 21 CFR 606.100(b)(19)(i) through (vi) and 606.160(b)(1)(viii) for requirements for standard operating 
procedures and records concerning the activities performed under 21 CFR 610.46, 610.47, and 610.48. 
 
  6  Contains Nonbinding Recommendations 
VI.  BLOOD AND BLOOD COMPONENTS INTENDED FOR MANUFACTURE 
INTO NON-INJECTABLE PRODUCTS 
 
There may be some limited uses for quarantined prior collections identified in the lookback 
either for current donations or for historical review donations that are not suitable for release 
from quarantine for their original intended use.  We recommend that you do not use such prior 
collections for transfusion or for manufacturing into injectable products.  You should destroy 
these prior collections as a general practice; however, in limited situations, release for research or 
for further manufacture is acceptable.  If released for research or for further manufacture into in 
vitro diagnostic reagents, you must relabel the prior collections with a BIOHAZARD legend 
(21 CFR 610.40(h)(2)(ii)(B)).  In addition, we recommend that you relabel the prior collections 
with two of the following statements: 
 
-  Collected from a donor who subsequently tested reactive for anti-HCV or HCV 
RNA.  An increased risk of transmission of HCV is present.  
 
and either 
 
-  Caution:  For Further Manufacturing Into In Vitro Diagnostic Reagents For 
Which There Are No Alternative Sources. 
 
  or  
 
-  Caution:  For Laboratory Research Use Only.  
 
If you release the units for further manufacture into injectable products, the units must include a 
statement on the container label indicating the exempted use specifically approved by FDA  
(21 CFR 610.40(h)(2)(ii)(D)). 
  7  Contains Nonbinding Recommendations 
 
Figure 1    Lookback for Hepatitis C Virus (HCV) Based on Current Donor Test Results Using a 
       Licensed Screening Test for HCV Antibody or a Licensed or Investigational NAT for HCV RNA 
 
     Current Repeatedly Reactive Licensed Anti-HCV Screening Test,  
                       or Reactive Licensed or Investigational NAT 
 
                                              Identify1 and quarantine2 prior collections. 
                             Notify2 consignees, request them to quarantine.           
                                                           
                                    If anti-HCV test is repeatedly reactive, test current sample using an                                                             If NAT Reactive only,  
                                         appropriate3 licensed multiantigen supplemental test4                                                                              destroy or relabel   
                                                                                                                                                                                                                                                      prior collections 
______________________________________________________________________________________________         obtained within 12 months6 
Supp. Test Positive,          Supp. Test Indeterminate,          Supp. Test Indeterminate,           Supp. Test Negative,              Supp. Test Negative,     
  NAT Reactive or                     NAT Reactive                         NAT Nonreactive                       NAT Reactive                     NAT Nonreactive                       Notify consignees 
     Nonreactive                                                                                                                                                                                                                   of test results5 
                                                                                                          
                                                                                                                                                                                                  
       Destroy or                         Destroy or                                   Destroy or                                     Destroy or                           Release prior                            Transfusion services:  
     relabel prior                      relabel prior                                relabel prior                                     relabel prior                               collections                                notify recipients7 
       collections                         collections                                  collections                                     collections6                                                                            of prior collections    
                                                                                                                                                                                                            Notify                                dating back 12 months 
       Notify                                   Notify                             Notify                                             Notify                                consignees   
       consignees                         consignees                                  consignees                                    consignees                           of test results5         
       of test results5                   of test results5                        of test results5                               of test results5  
                                                                                    
                                                                                                     Recipients                                 
      Transfusion                        Transfusion                                    need not                              Transfusion services:    
         services:                              services:                                   be notified                               notify recipients7  
     notify recipients7               notify recipients7                                                                          of prior collections 
                                                                                                                                                 dating back 12 months 
 
1 If repeatedly reactive for anti-HCV, prior collections should be identified from the same donor dating back to the date 12 months prior to the donors most recent nonreactive licensed 
multiantigen screening test.  If NAT-reactive only, prior collections should be identified from the same donor dating back 12 months prior to the reactive NAT. 
2 Within 3 calendar days after the day of obtaining the reactive NAT result or repeatedly reactive anti-HCV screening test result. 
3 An appropriate supplemental test is one that includes all the antigens contained in the screening test that was performed. 
4 Certain licensed HCV NAT have been labeled with a limited supplemental claim.  When current donor test results are repeatedly reactive on an anti-HCV screening test and 
reactive on HCV NAT, the reactive NAT acts as a positive supplemental test and it is not necessary to perform a licensed multiantigen supplemental test for anti-HCV. 
5 Notify consignees of all test results within 45 calendar days of the current repeatedly reactive anti-HCV or NAT-reactive test result. 
6 Prior collections obtained more than 12 months prior to the date of the NAT-reactive donation may be released. 
7 Transfusion services must identify and notify recipients of identified prior collections, or the recipients physician of record, as appropriate.
  8  Contains Nonbinding Recommendations 
Table 1  Current Review 
 
You must take the following steps when donor test results for antibody to Hepatitis C Virus (anti-HCV) by a licensed screening 
test are repeatedly reactive, or a licensed or investigational HCV RNA Nucleic Acid Test (NAT) is reactive.  You must 
identify and quarantine prior collections, notify the consignees and request them to quarantine prior collections.  Then... 
     
If the initial test is a  And the additional testing1  is a licensed  Then ... 
licensed ...  or investigational  ... 
        Notify   Destroy/  Transfusion  Release prior collection 
  Consignee of  Relabel prior  services notify 
test result  collection  recipients or 
recipients 
physician of 
record 
    NAT  Reactive         
Anti-HCV  NR  X  X3  X3 
    Appropriate   Positive         
    Multiantigen       
    Supplemental       
Anti-HCV  RR  Test  X  X  X 
NAT  Nonreactive  
    Appropriate  Positive         
    Multiantigen       
    Supplemental       
Anti-HCV  RR  Test  X  X  X 
NAT2  Reactive 
    Appropriate  Indeterminate         
    Multiantigen     
    Supplemental     
Anti-HCV  RR  Test  X  X 
  NAT  Nonreactive 
    Appropriate   Indeterminate         
    Multiantigen       
    Supplemental       
Anti-HCV  RR  Test  X  X  X 
  NAT2  Reactive 
    Appropriate  Negative         
    Multiantigen     
    Supplemental     
Anti-HCV  RR  Test  X  X 
  NAT  Nonreactive 
    Appropriate   Negative         
    Multiantigen         
    Supplemental         
Anti-HCV  RR  Test  X  X3  X3  X4 
 
NAT2  Reactive 
1Appropriate additional testing includes all the antigens contained in the screening test that was performed 
2Certain licensed HCV NAT have been labeled with a limited supplemental claim.  When current donor test results 
are repeatedly reactive on an anti-HCV screening test and reactive on HCV NAT, the reactive NAT acts as a positive 
supplemental test and it is not necessary to perform a licensed multiantigen supplemental test for anti-HCV. 
3Collections during the 12 months prior to the date of the donation testing NAT reactive 
4Release collections from more than 12 months prior to the date of the donation testing NAT reactive 
NR means nonreactive 
RR means repeatedly reactive   
  9  Contains Nonbinding Recommendations 
VII.  REFERENCES 
 
1.  Sayers, M.H., and Gretch, D.R.  Recombinant immunoblot and polymerase chain reaction 
testing in volunteer whole blood donors screened by a multi-antigen assay for hepatitis C virus 
antibodies.  Transfusion 33:809-813 (1993). 
 
2.  Kleinman, S. et al.  Increased detection of hepatitis C virus (HCV)-infected blood donors by a 
multiple-antigen HCV enzyme immunoassay.  Transfusion 32:805-813 (1992). 
 
3.  Yun, Z. et al.  Detection of Hepatitis C Virus (HCV) RNA by PCR Related to HCV 
Antibodies in Serum and Liver Histology in Swedish Blood Donors.  J Med Virol 39:57-61 
(1993). 
 
4.  Dow, B.C. et. al.  Relevance of RIBA-3 Supplementary Test to HCV PCR Positivity and 
Genotypes for HCV Confirmation of Blood Donors.  J Med Virol 49:132-136 (1996).   
 
5.  Alter, H.J. To C or Not to C:  These Are the Questions.  Blood 85:1681-1695 (1995). 
 
6.  CDC.  Recommendations for Prevention and Control of Hepatitis C Virus (HCV) Infection 
and HCV-Related Chronic Disease.  MMWR Morb Mortal Wkly Rep 47 (RR-19) (1998). 
 
7.  Schreiber, G.B. et al.  The Risk of Transfusion-Transmitted Viral Infections.  N Engl J Med 
334:1685-1690 (1996).
  10  Contains Nonbinding Recommendations 
APPENDIX   
 
Recommendations for implementing historical lookback required under 21 CFR 610.48 are 
included in Figures 2-4 and Tables 2-5. 
  11  Contains Nonbinding Recommendations 
Figure 2    Lookback for Hepatitis C Virus (HCV) Based on Historical Donor Test Results Using a  
Licensed Screening Test for HCV Antibody or a Licensed or Investigational NAT for HCV RNA 
 
               Historical Repeatedly Reactive Licensed Anti-HCV Screening Test or Reactive Licensed or Investigational NAT 
  
                                                                                                          Identify1 and quarantine2 prior collections.                                                            
                Notify2 consignees, request them to quarantine. 
      
                                                                                                                                                                                                                                
                                                               If Anti-HCV test was repeatedly reactive, review record of                                                                                                If NAT-        Supplemental 
                                                                         previous multiantigen supplemental test                                                                                  reactive only,   Test Not Done 
                                                                                                                                                                                                                                             destroy or        on Historical 
                                                                                                                                                                                                                                                                          relabel prior       Repeatedly Reactive 
            Licensed or Investigational RIBA 2.0                                                                                                             Licensed or Investigational RIBA 3.03                         collections           Donation 
                                                                                                                                                                                                                                                obtained within   (Continued 
Positive                         Negative                            Indeterminate                            May test again4                                    Positive                   Negative                          Indeterminate             12 months           on Figure 3) 
                                                                                                                                                                                                                                                                                                                            
                                                                                                                                                                                                                                             
Destroy           If NAT-     If NAT-reactive,      If NAT-    If NAT-reactive,   If EIA 2.0 was run, may perform                Destroy or      If NAT-    If NAT-reactive,    If NAT-     If NAT-reactive,     Notify                  
or relabel        nonreactive     destroy or         nonreactive      destroy or       licensed EIA 3.0 or alternative test6             relabel prior    nonreactive    destroy or        nonreactive      destroy or         consignees             
prior             or not done,    relabel prior        or not done,     relabel prior                                                                        collections    or not done,   relabel prior        or not done,     relabel prior      of test results    
collections      and if            collections             and if            collections        Nonreactive            Repeatedly                                          release         collections        destroy or       collections                 
                     screening         obtained             not tested                                                                 Reactive                           Notify             prior            obtained          relabel prior                                                                              
Notify            test was      within 12 mos.5            again,              Notify                                                           consignees   collections   within 12 mos.5    collections       Notify               Transfusion services:                
consignees    EIA 2.0,                                     destroy or        consignees                                                                          of  test results                                                                         consignees         notify recipients     
of test             release               Notify           relabel prior      of test results        Release      If not tested    May test                                  Notify            Notify              Notify    of test results      (or physician of record) of 
results               prior              consignees         collections                                   prior            again,         again on                                consignees    consignees        consignees                                   prior collections 
                  collections5        of test results                 collections7 destroy or   licensed or         Transfusion   of test       of test results     of test result                               dating back 12 months 
                                                                            Notify         Transfusion                         relabel prior   investigational       services:        results                                                       Transfusion                       
Transfusion    Notify                                        consignees        services:           Notify        collections     RIBA 3.0              notify                                                      Recipients    services: notify    
services:      consignees       Transfusion              of test             notify           consignees                                                     recipients8                       Transfusion         need not        recipients8                                                           
notify             of test          services: notify          results          recipients8          of test         Notify                                                                       services: notify         be notified                                                                        
recipients8      results      recipients (or physician                                                           results  consignees                                                        recipients (or physician                                                              
                                        of record) of prior                                                                      of test results                                           of record) of prior collections                                                                               
                                    collections dating back    Transfusion                                                                                                     dating back  12 months                                                                                         
                                          12 months                     services:                                           Transfusion services:                                        
                                                                            notify recipients8                                    notify recipients8                                                                                                                                   
 
1 If repeatedly reactive, prior collections should be identified from the same donor dating back to the date 12 months prior to the donors most recent nonreactive licensed multiantigen screening test.  If 
NAT-reactive only, prior collections should be identified from the same donor dating back 12 months prior to the date of the NAT-reactive donation. 
2 Within 3 calendar days after the day of identifying the reactive NAT result or repeatedly reactive anti-HCV screening test result. 
3 Testing already performed as an in-house service by Chiron Corp. using the Chiron RIBA HCV 3.0 SIA, or testing already performed using an investigational RIBA 3.0 in accordance with previous 
guidance, is also acceptable. 
4 A previously frozen serum or plasma sample from the repeatedly reactive/RIBA 2.0 indeterminate donation or a fresh sample from the same donor may be tested again.  Notify consignees within 45 
calendar days of completing the additional testing. 
5 If the repeatedly reactive screening test was EIA 3.0 and the negative supplemental test was RIBA 2.0, destroy or label prior collections and notify transfusion recipients.  Alternatively, may test again 
using RIBA 3.0 (see outcomes at right).  Notify consignees within 45 calendar days of completing the supplemental test result. 
6An alternative test for anti-HCV is a test of equal or greater sensitivity in comparison to the licensed HCV EIA 3.0.  
7If a RIBA 2.0 or RIBA 3.0 is negative, prior collections obtained more than 12 months prior to the date of the NAT-reactive donation may be released.     
8 Transfusion services must identify and notify recipients, or the recipients physician of record, as appropriate, of identified prior collections dating back to the date 12 months prior to the donors most 
recent nonreactive licensed multiantigen screening test for anti-HCV. 
  12  Contains Nonbinding Recommendations 
Figure 3       Lookback for Hepatitis C Virus (HCV) Based on Historical Donor Test Results Using a 
Licensed EIA 2.0 or EIA 3.0 Test for HCV Antibody or a Licensed or Investigational NAT for HCV RNA (Cont.) 
   
                         Historical Repeatedly Reactive Licensed               Identify and quarantine prior collections.    
                                     Anti-HCV EIA 2.0 or 3.0               Notify consignees, request them to quarantine. 
 
                                                               Supplemental Test Not Done on Historical Repeatedly Reactive Donation 
 
 
                                If Stored Sample1 or Fresh                                                     If Stored Sample1 or Fresh 
                                       Sample from the Same Donor is Available:                             Sample from the Same Donor is Not Available:  
   
 
                           If repeatedly reactive on an EIA 2.0:                                                     If repeatedly reactive on an EIA 3.0                  
                                             or alternative test:                                               Destroy or relabel         
                                                                                                      prior collections 
 
                Perform       Perform licensed EIA 3.0                                                           Perform licensed                                   Perform                           Notify consignees   
        licensed RIBA 2.0 or            or alternative test3                                                           or investigational NAT                       licensed RIBA 3.02                   of repeatedly 
               RIBA 3.02                                                                                                                                                                                                                       reactive result 
                                      Nonreactive                    Repeatedly                                           Reactive                    Nonreactive            (See outcomes 
           (See outcomes                                               Reactive                                                                                                               for RIBA 3.0 
             for RIBA 2.0                                                                                                                                                in Figure 2)       
             or RIBA 3.0                                     May test              If not tested              May test                                               Transfusion services: 
             in Figure 2)   Release            Perform           If not tested              again on            again, destroy             again on                                                  notify recipients4 
                                          prior                licensed         again, destroy             licensed              or relabel prior             licensed 
                                           collections      RIBA 3.0            or relabel prior            RIBA 3.0              collections               RIBA 3.0       
                                                                                               collections         
    Notify             (See outcomes                                    (See outcomes     Notify consignees     (See outcomes 
    consignees        for RIBA 3.0    Notify consignees     for RIBA 3.0         of test results5          for RIBA 3.0 
    of test results5    in Figure 2)          of test results5        with a reactive                  with a nonreactive 
                                              NAT in Figure 2)6                   NAT in Figure 2) 
                                                                                                                 Transfusion services:  
                                                    Transfusion services:                               notify recipients4 
                                                       notify recipients4 
 
1 A previously frozen serum or plasma sample from the same repeatedly reactive donation. 
2 If a licensed RIBA 2.0 test or an investigational RIBA 3.0 test was performed consistent with previous guidance, refer to Figure 2 for outcomes. 
3 An alternative test for anti-HCV is a test of equal or greater sensitivity in comparison to the licensed HCV EIA 3.0. 
4 Transfusion services must identify and notify recipients, or the recipients physician of record, of identified prior collections dating back to the date 12 months prior to the donors most recent nonreactive licensed multiantigen 
screening test for anti-HCV. 
5 Notify consignees within 45 calendar days of completing the additional testing. 
6 If a NAT is reactive and further testing by RIBA 3.0 is negative or indeterminate, transfusion services should identify and notify recipients, or the recipients physician of record, of identified prior collections dating back 12 
months prior to the date of the NAT-reactive donation.  If the RIBA 3.0 is negative, prior collections obtained more than 12 months prior to the date of the NAT-reactive donation may be released.  If the RIBA 3.0 is 
indeterminate, prior collections should be destroyed or labeled consistent with section VI of this guidance.  Note that a nonreactive NAT does not obviate lookback for a repeatedly reactive donation. 
 
  13  Contains Nonbinding Recommendations 
            Figure 4                           Lookback for Hepatitis C Virus (HCV) Based on Historical Donor Test Results 
Using an EIA 1.0 for HCV Antibody 
 
                        Historical Repeatedly Reactive                   Identify1 and quarantine prior collections.  
                           Licensed Anti-HCV EIA 1.0       Notify2 consignees, request them to quarantine. 
                                                                               
 
  
 
                                               Additional testing performed.                                                                                                                                    No additional testing performed. 
                                                                                                                            
 
               Stored sample3 or fresh sample                               Stored sample was tested on RIBA 1.0, Neut-Peptide EIA, or RIBA 2.0,                                                                                     S/CO < 2.5         S/CO > 2.5 or cannot 
          from the same donor was tested on                                                      or stored or fresh sample from the same donor                                                                                                                                                 be calculated 
              EIA 2.0, EIA 3.0, or alternative test4                                                          was tested on RIBA 3.0 or NAT4 
                                                                                                                                                                                                                                                                                                        Destroy or                   Destroy or  
                                                                                                                                                                                                                                                                                         relabel prior             relabel prior 
          Repeatedly              Nonreactive           Reactive                    Positive       Indeterminate                   Indeterminate      Negative                   Negative                                  collections                   collections 
            Reactive                            NAT                  Supplemental             RIBA 1.0 or Neut-                RIBA 3.0           RIBA 2.0 or            RIBA 1.0 or                                                                                     
                                                                                                               Test                   Peptide EIA or RIBA 2.0,                                    RIBA 3.0           Neut-Peptide EIA                               Notify                           Notify 
                                                                                                                                            or Nonreactive NAT                                                                                                                            consignees                  consignees 
     No                May test            Release      If no           May test                                                                                                                 Release                                                                        of test                           of test 
additional      again5 using           prior       additional   again using                                                                                  Destroy or             prior                If no                        May test              results                           results 
     test            RIBA 2.0 or      collections     test is      RIBA 2.0 or     Destroy or                                                            relabel prior          collections      additional                  again using                                 
                      RIBA 3.0 or                        performed,    RIBA 3.05      relabel prior           If no                    May test        collections                                   test is                         EIA 2.0,           Recipients                         
                            NAT               Notify     destroy or       (See             collections      additional             again using                                     Notify         performed,                  EIA 3.0, or          need not                  Transfusion 
Destroy or                             consignees   relabel prior   outcomes                                 test is                 EIA 3.0 or           Notify             consignees      destroy or              alternative test4,5      be notified                   services: 
relabel prior    (See outcomes     of test      collections      for                Notify          performed,         alternative test4,5   consignees            of test          relabel prior                or RIBA 3.0                                             notify   
collections     for RIBA 2.0,      results6                         RIBA 2.07      consignees       destroy or            or RIBA 3.0           of test                results6        collections                    or NAT                                             recipients8 
                        RIBA 3.0,                             Notify     or RIBA 3.07      of test           relabel prior                                          results6                                                                                  
Notify               or NAT                              consignees    with a             results6         collections        (See outcomes                                                          Notify                  (See outcomes                                                      
consignees      in the bracket                          of test        reactive                                                            for EIA 3.0         Recipients                                 consignees              for EIA 2.0 or                                                     
of test results6   to the right)7                         results6         NAT                                      Notify              or RIBA 3.0          need not                                    of test                    EIA 3.0 in the                                                  
                                                         in Fig.2)        Transfusion   consignees           in Figure 2)         be notified                                  results                        bracket at far left,                                                 
                                                                                                              services:           of test                                                                                                                             or for RIBA 3.0                                        
Transfusion                                              Transfusion                            notify              results                                                                                            Recipients                 or NAT in this                                               
  services:                                                    services:                           recipients8                                                                                                                 need not                bracket to the left)6              
    notify                                                        notify                                                                                                                                                              be notified                  
 recipients8                                                recipients8                                                  Transfusion                                                                                                                              
                                                                                                                                        services: 
                                                                                                                                          notify 
                                                                                                                                       recipients8 
 
1Previously distributed units should be identified dating back 12 months prior to the donors most recent nonreactive licensed screening test for anti-HCV.  
2Within 3 calendar days after the day of identifying the repeatedly reactive anti-HCV screening test results. 
3 A previously frozen serum or plasma sample from the same repeatedly reactive donation.  
4 An alternative test for anti-HCV is a test of equal or greater sensitivity in comparison to the licensed HCV EIA 3.0. 
5  The supplemental test performed should include all the antigens contained in the screening test that was performed.   
6 Notify consignees within 45 calendar days of obtaining the supplemental or additional test result. 
7 If a NAT is reactive and further testing by RIBA 2.0 or RIBA 3.0 is negative, prior collections obtained more than 12 months prior to the date of the NAT-reactive donation may be released, and transfusion services must 
identify and notify recipients of prior collections dating back 12 months prior to the date of the NAT-reactive donation.  If the RIBA 2.0 is indeterminate, destruction or labeling of prior collections and notification of recipients 
are not limited to collections within 12 months prior to the NAT-reactive donation.  If the RIBA 3.0 is indeterminate, destruction or labeling of prior collections is not limited to collections within 12 months prior to the NAT-
reactive donation, but notification of recipients should extend back only 12 months prior to the NAT-reactive donation.  Note that a nonreactive NAT does not obviate lookback for a repeatedly reactive donation.  
8 Transfusion services must identify and notify recipients, or recipients physician of record, as appropriate, of identified prior collections.
  14  Contains Nonbinding Recommendations 
 
Table 2  Historical Review 
 
You must take the following steps when donor test results for antibody to Hepatitis C Virus (anti-HCV) by a licensed screening 
test are repeatedly reactive, or a licensed or investigational HCV RNA Nucleic Acid Test (NAT) is reactive.  You must 
identify and quarantine prior collections, notify the consignees and request them to quarantine prior collections.  Then ... 
     
If the historical  And the historical additional  Then ... 
initial test is a  testing1  is a licensed or 
licensed ...  investigational  ... 
        Notify   Destroy/  Transfusion  Release prior collection 
  Consignee of test  Relabel prior  services notify 
result  collection  recipients or 
recipients 
physician of 
record 
         
EIA 2.0  RR  NFT  Sample available  See Table 4 
or  
3.0 
               
    RIBA 2.0  Positive       
EIA 2.0  RR  X  X  X 
NAT  Reactive, 
or 3.0 
Nonreactive or NP 
               
EIA 2.0  RR  RIBA 2.0  Negative  X  X 
  NAT  Nonreactive or NP 
               
EIA 3.0  RR  RIBA 2.0  Negative  X  X  X 
NAT  Nonreactive or NP 
    RIBA 2.0  Negative       
EIA 2.0   RR  NAT  Reactive  X  X2  X2  X3 
    RIBA 2.0  Negative         
EIA  3.0  RR  X  X  X 
NAT  Reactive 
    RIBA 2.0  Indeterminate         
EIA 2.0  RR  NAT  Nonreactive or NP  X  X  X 
or 3.0 
    RIBA 2.0  Indeterminate         
EIA 2.0  RR  X  X  X 
or 3.0  NAT  Reactive 
    RIBA 2.0  Indeterminate         
    (MTA)        
    EIA 3.0 or  Nonreactive     
EIA 2.0  RR  alternative  X  X 
NAT  Nonreactive or NP   
    RIBA 2.0  Indeterminate         
    (MTA)          
    EIA 3.0 or         
EIA 2.0  RR  alternative  Reactive  X  X  X 
NAT  Nonreactive or NP 
    RIBA 2.0  Indeterminate   
     
NAT  Nonreactive or NP 
EIA 2.0  RR  See Table 3 
or 3.0  RIBA 3.0   
EIA 2.0  NR  NAT only  Reactive  X  X2  X2   
or 3.0 
1Appropriate additional testing includes all the antigens contained in the screening test that was performed 
2Collections during the 12 months prior to the date of the donation testing NAT reactive 
3Release collections more than 12 months prior to the date of the donation testing NAT reactive 
NR means non-reactive 
RR means repeatedly reactive 
MTA means may test again 
NFT means not further tested 
NP means not performed
15 
  Contains Nonbinding Recommendations 
 
Table 3  Historical Review 
 
You must take the following steps when donor test results for antibody to Hepatitis C Virus (anti-HCV) by Licensed HCV 
EIA 2.0 or EIA 3.0 are repeatedly reactive, or a licensed or investigational HCV RNA Nucleic Acid Test (NAT) is 
reactive.  You must identify and quarantine prior collections, notify the consignees and request them to quarantine prior 
collections.  Then ... 
   
If the historical initial  And the historical additional  Then ... 
test is a licensed ...  testing1 is a licensed or 
investigational ... 
        Notify   Destroy/  Transfusion  Release prior 
  Consignee of test  Relabel prior  services notify  collection 
result  collection  recipients or 
recipients 
physician of 
record 
               
    RIBA 3.0  Positive       
EIA 2.0 or 3.0  RR  X  X  X 
NAT  Reactive, 
Nonreactive or NP 
    RIBA 3.0  Negative         
EIA 2.0 or 3.0  RR  X  X 
NAT  Nonreactive or NP 
    RIBA 3.0  Negative         
EIA 2.0 or 3.0  RR  X  X2  X2  X3 
NAT  Reactive 
    RIBA 3.0  Indeterminate                                                                                                                                                                                                     
EIA 2.0 or 3.0  RR  X  X 
NAT  Nonreactive or NP 
    RIBA 3.0  Indeterminate         
EIA 2.0 or 3.0  RR  X  X  X 
NAT  Reactive 
1Appropriate additional testing includes all the antigens contained in the screening test that was performed 
2Collections during the 12 months prior to the date of the donation testing NAT reactive 
3Release collections more than 12 months prior to the date of the donation testing NAT reactive 
RR means repeatedly reactive 
NFT means not further tested 
NP means not performed
16 
  Contains Nonbinding Recommendations 
Table 4  Historical Review 
 
You must take the following steps when donor test results for antibody to Hepatitis C Virus (anti-HCV) by Licensed HCV 
EIA 2.0 or EIA 3.0 are repeatedly reactive, or a licensed or investigational HCV RNA Nucleic Acid Test (NAT) is 
reactive.  You must identify and quarantine prior collections, notify the consignees and request them to quarantine prior 
collections.  Then ... 
     
If the historical  And the historical additional testing1  Then ... 
initial test is a  is a licensed or investigational ... 
licensed ... 
        Notify   Destroy/  Transfusion  Release prior 
  Consignee of test  Relabel prior  services notify  collection 
result  collection  recipients or 
recipients 
physician of 
record 
         
    RIBA 2.0  See Table 2 
EIA 2.0  RR 
     
RIBA 3.0  See Table 3 
    EIA 3.0 or           
EIA 2.0  RR  alternative  Nonreactive  X  X 
    EIA 3.0 or           
    alternative  Reactive       
EIA 2.0  RR  X  X  X 
     
(NFT) 
    EIA 3.0 or     
    alternative  Reactive   
EIA 2.0  RR  See Table 3 
   
RIBA 3.0 
    RIBA 3.0     
EIA 3.0  RR  See Table 3 
    NAT  Nonreactive   
     
EIA 2.0  RR  See Table 3 
(MTA)   
or 3.0 
RIBA 3.0 
 
      Nonreactive or         
    NAT  Reactive         
EIA 2.0  RR  X  X2  X2  X3 
   
or 3.0 
(NFT) 
 
         
    NAT  Reactive   
EIA 2.0  RR  See Table 3 
(MTA)   
or 3.0 
RIBA 3.0   
 
               
             
EIA 2.0  RR  (NFT)  No Sample   X  X  X 
or 3.0  Available 
1Appropriate additional testing includes all the antigens contained in the screening test that was performed 
2Collections during the 12 months prior to the date of the donation testing NAT reactive 
3Release collections more than 12 months prior to the date of the donation testing NAT reactive 
RR means repeatedly reactive 
MTA means may test again  
NFT means not further tested
17 
  Contains Nonbinding Recommendations 
 
Table 5  Historical Review 
 
You must take the following steps when donor test results for antibody to Hepatitis C Virus (anti-HCV) by Licensed HCV 
EIA 1.0 are repeatedly reactive.  You must identify and quarantine prior collections, notify the consignees and request 
them to quarantine prior collections.  Then ... 
     
If the historical initial test is  And the additional testing1 is a  Then ... 
a licensed ...  licensed or investigational ... 
        Notify   Destroy/  Transfusion  Release prior 
  Consignee of test  Relabel prior  services notify  collection 
  result  collection  recipients or 
recipients 
physician of 
record 
    (NFT)           
EIA 1.0  S/CO  X  X 
 2.5 
    (NFT)           
  S/CO >2.5 or       
EIA 1.0  cannot be  X  X  X 
calculated 
    EIA 2.0 or 3.0  Reactive         
    or alternative       
EIA 1.0  RR  X  X  X 
(NFT)   
 
    EIA 2.0 or 3.0  Reactive   
    or alternative   
EIA 1.0  RR   
(MTA)   
  See Below 
RIBA 2.0 or 
 
3.0 or NAT 
    EIA 2.0 or 3.0  Nonreactive         
EIA 1.0  RR  or alternative  X  X 
 
    NAT  Reactive         
         
EIA 1.0  RR  X  X  X 
(NFT)   
 
    NAT  Reactive   
     
     
EIA 1.0  RR  (MTA)  Negative  X  X2  X2  X3 
  RIBA 2.0 
Indeterminate  X  X  X   
(MTA)  Negative  X  X2  X2  X3 
RIBA 3.0 
Indeterminate  X  X  X2   
    RIBA 1.0, 2.0,  Positive         
    or  3.0; or       
EIA 1.0  RR  Neut-Peptide  X  X  X 
  EIA 
 
18 
  Contains Nonbinding Recommendations 
Table 5 (Continued)  Historical Review 
You should take the following steps when donor test results for antibody to Hepatitis C Virus (anti-HCV) by Licensed HCV 
EIA 1.0 are repeatedly reactive.  You should identify and quarantine prior collections, notify the consignees and request 
them to quarantine prior collections.  Then ... 
     
If the historical  And the additional testing1 is a  Then ... 
initial test is a  licensed or investigational  ... 
licensed ... 
        Notify   Destroy/  Transfusion  Release prior 
Consignee of test  Relabel prior  services notify  collection 
result  collection  recipients or 
recipients 
physician of 
record 
    RIBA 1.0 or 2.0;  Indeterminate         
    or Neut-Peptide       
EIA 1.0  RR  EIA  X  X  X 
  (NFT)   
    NAT  Nonreactive         
EIA 1.0  RR  (NFT)    X  X  X 
    RIBA 1.0 or 2.0;  Indeterminate         
    or Neut-Peptide         
    EIA   X  X 
   
EIA 1.0  RR   NAT  Nonreactive 
(MTA) EIA 3.0 or     
alternative; or  See Table 3 
RIBA 3.0  
    RIBA 1.0 or 2.0;         
EIA 1.0  RR  or Neut-Peptide  Indeterminate     
EIA     
     
NAT  Nonreactive or NP  X  X 
 
(MTA) EIA 3.0 or 
alternative; or   Nonreactive 
 
RIBA 3.0  Negative 
           
RIBA 3.0  Indeterminate 
EIA 1.0  RR  X  X 
    RIBA 2.0 or 3.0  Negative         
EIA 1.0  RR      X  X 
NAT  Nonreactive or NP 
    RIBA 2.0 or 3.0  Negative         
EIA 1.0  RR    X  X3 
NAT  Reactive 
    RIBA 1.0 or Neut- Negative         
    Peptide EIA     
EIA 1.0  RR  X  X 
(NFT)   
    RIBA 1.0 or Neut- Negative   
    Peptide EIA   
     
(MTA) EIA 2.0 or   
EIA 1.0  RR  See outcomes above 
3.0 or alternative; 
or RIBA 3.0; or 
NAT 
1Appropriate additional testing includes all the antigens contained in the screening test that was performed 
2Collections during the 12 months prior to the date of the donation testing NAT reactive 
3Release collections more than 12 months prior to the date of the donation testing NAT reactive 
NR means non-reactive 
RR means repeatedly reactive 
MTA means may test again 
NFT means not further tested 
19