American Journal of Transplantation 2013; 13: 21862190

Wiley Periodicals Inc.


C

Copyright 2013 The American Society of Transplantation

and the American Society of Transplant Surgeons
doi: 10.1002/ajt.12260

Brief Communication

Deceased Organ Donor Screening for HIV, Hepatitis B,

and Hepatitis C Viruses: A Survey of Organ
Procurement Organization Practices
N. Theodoropoulos1,2,*, A. Jaramillo3,
D. P. Ladner2,4 and M. G. Ison2,4,5

Key words: Deceased organ donor, HIV, hepatitis B,

hepatitis C, organ procurement organization, screening, nucleic acid testing, survey

Division of Infectious Diseases, Department of Internal

Medicine, The Ohio State University College of Medicine,
Columbus, OH y
2
Northwestern University Transplant Outcomes Research
Collaborative, Comprehensive Transplant Center,
Northwestern University Feinberg School of Medicine,
Chicago, IL
3
Gift of Hope Organ & Tissue Donor Network, Itasca, IL
4
Division of Organ Transplantation, Department of
Surgery, Northwestern University Feinberg School of
Medicine, Chicago, IL
5
Division of Infectious Diseases, Department of
Medicine, Northwestern University Feinberg School of
Medicine, Chicago, IL
*Corresponding author: Nicole Theodoropoulos,
nicole.theodoropoulos@osumc.edu
y
Research performed while at Northwestern University,
currently at The Ohio State University.
Although Organ Procurement and Transplantation
Network (OPTN) policy requires that all potential
deceased organ donors are screened for human
immunodeficiency (HIV), hepatitis B (HBV) and hepatitis C (HCV) viruses by serology, no current policy
requires the use of nucleic acid testing (NAT) for organ
donor screening. An electronic survey was sent to 58
organ procurement organizations (OPO) in the United
States to assess current screening practices of potential deceased organ donors. Fifty-seven responses
were collected for data analysis; not all respondents
answered all questions. All OPOs performed required
HIV, HBV and HCV serology screening and 48 (84%)
performed confirmatory testing for seropositive donors. Ninety-eight percent, 75% and 97% of OPOs
performed prospective HIV, HBV and HCV NAT,
respectively. Fifty-two percent and 47% used a
transcription-mediated amplification assay for HIV
and HCV NAT, respectively. Of the 56 respondents
that performed HIV NAT and 55 respondents that
performed HCV NAT, 39 tested all donors. Seventeen
(32%) OPOs performed confirmatory testing for all
HIV-positive NAT results, and 15 (27%) OPOs performed confirmatory testing for all HCV-positive NAT
results. Since 2008, the number of OPOs performing
NAT has increased and more OPOs are testing all
donors.
2186

Abbreviations: Ab, antibody; EIA, enzyme immunoassay; ELISA, enzyme-linked immunosorbent assay;
FDA, Food and Drug Administration; HBcAb, hepatitis
B core antibody; HBsAg, hepatitis B surface antigen;
HBV, hepatitis B virus; HCV, hepatitis C virus; HIV,
human immunodeficiency virus; IR, increased risk;
NAT, nucleic acid test; OPO, organ procurement
organization; OPTN, Organ Procurement and Transplantation Network; PCR, polymerase chain reaction;
PDOD, potential deceased organ donor; RIBA, recombinant immunoblot assay; TC, transplant center;
TMA, transcription-mediated amplification; TAT, turnaround-time.
Received 07 November 2012, revised 18 March 2013
and accepted 20 March 2013

Introduction
The Organ Procurement and Transplantation Network
(OPTN) currently mandates that all deceased organ donors
are screened for human immunodeficiency (HIV) with
a U.S. Food and Drug Administration (FDA)-licensed
serologic test and hepatitis B (HBV) and hepatitis C (HCV)
viruses with a FDA-licensed, approved or cleared serologic
test (1). The well-publicized transmission of HIV and HCV to
four organ transplant recipients by a seronegative infected
donor in 2007 brought renewed interest to the optimization
of donor screening (2). Although nucleic acid testing (NAT)
is not mandated by current OPTN policy, many organ
procurement organizations (OPOs) have added NAT to
routine serologic testing in order to detect acute infections
and thereby, reduce the risk of donor transmission of HIV,
HBV and HCV. Since NAT directly detects viral genetic
material, the period between when one is infected and
when the test can detect the infection (window period) is
substantially shortened with NAT compared to serologic
tests that detect antibody formation (Table 1) (36).
In 2008, a survey of 58 U.S. OPOs demonstrated that 78%
of OPOs performed NAT on at least some potential
deceased organ donors (PDOD) (7). Only 36% of these

Survey of OPO Screening Practices

Table 1: Window periods by assay type (36)
Virus

Serology

NAT1

HIV
HBV
HCV

22 days
44 days
66 days

59 days
22 days
37 days

Based on individual blood donor data.

OPOs received the NAT result prior to the decision to use

organs for transplant (7). Eight OPOs stated that they would
be unable to comply if prospective NAT organ donor
screening became mandatory because of the lack of test
availability (7). Another survey of all U.S. OPOs performed
in 2008 reported that 51.7% of OPOs performed HIV NAT
on all donors, 24.1% performed HBV NAT on all donors, and
48.3% performed HCV NAT on all donors (8). Twenty-four
percent of OPOs never used HIV NAT, 65.5% never used
HBV NAT and 31% never used HCV NAT (8).
Controversy over the use of NAT in deceased organ donor
screening remains, with critics citing cost, logistical concerns
and the possibility of false-positive NAT results as the major
barriers to implementation (9). The proposed U.S. Public
Health Service Guideline for Reducing Transmission of HIV,
HBV and HCV through Solid Organ Transplantation has
advocated for a broader use of NAT in deceased organ donor
screening, adding further focus on the question of NAT
capacity of U.S. OPOs (10). We therefore conducted this
study to assess the current OPO screening practices for HIV,
HBV and HCV in the United States.

Methods
In November 2011, after approval by our Institutional Review Board, a
web-based survey was developed to assess the current screening
practices by OPOs across the United States. The survey was developed
by the co-authors using published data from prior surveys (8) and
reviewed by OPO representatives to ensure the questions were clear and
the survey would be easy to complete. The survey was disseminated
electronically by the Association of Organ Procurement Organizations
(AOPO) via SurveyMonkey (http://www.surveymonkey.com) to Executive and Procurement Directors at each of the 58 OPOs in the United
States. Respondents consented to the study by answering the first
question asking if they agree to participate. Respondents had the option
of remaining anonymous or providing contact information. Reminder
emails were sent until all OPOs responded; the last response was
received in August 2012. Survey questions can be found in the
supplemental materials. Questions were asked about potential deceased
organ donors (PDODs), defined as a deceased patient who undergoes
evaluation by an OPO and has organs offered for the purpose of
transplantation. Descriptive statistics were calculated using anonymous
survey data.

Results
We received 60 survey responses. One response was blank,
and the respondent declined further study participation. Not
American Journal of Transplantation 2013; 13: 21862190

all respondents answered all questions. Fifty-seven OPOs

answered the survey and voluntarily provided identifying
information (OPO name and name of individual respondent). The two unidentified responses had data in their
answer that matches with public OPO-level data maintained by the OPTN, and one of these respondents
appeared to represent the 58th OPO while the other
appeared to be a second response from one OPO. Since
we were not certain of the origin of the two anonymous
responses, they were excluded and we used a total of
57 responses for data analysis. The respondents reported a
total of 756 910 death notification calls, 7648 PDODs, and
7107 deceased donors with at least one organ transplanted
in 2010.
Nucleic acid testing
Fifty-six (98.2%), 43 (75.4%) and 55 (96.5%) respondents
performed prospective HIV, HBV and HCV NAT on at least
some PDODs, respectively. The majority of OPOs
performed NAT on all PDODs, regardless of risk stratification (Table 2b and Figure 1). OPOs reported a total of 8825
HIV NAT (median 82 [01623]), 6482 HBV NAT (median 43
[01671]), and 9671 HCV NAT (median 81 [01621]) were
performed to screen PDODs in 2010.
Nucleic acid test platforms
Of the 52 OPOs who responded to questions about HIV
NAT assay platforms, 27 (51.9%) used a transcriptionmediated amplification (TMA) assay and 24 (46.2%) used a
polymerase chain reaction assay (PCR) for HIV NAT, and 1
OPO did not specify. Similar numbers are noted for the 51
OPOs that responded regarding HCV NAT platforms: 24
(47.1%) used a TMA assay, 23 (45.1%) used a PCR assay
and 4 (7.8%) did not specify test name. Of the 41 OPOs
responding about HBV NAT platforms, 19 (46.3%) used a
TMA assay and 22 (53.7%) used a PCR assay.

1 (1.8%)

Never
Other
OPO IR & TC Request
OPTN IR & TC Request
TC request
OPO-dened IR donors
OPTN IR donors
All donors

14 (24.6%)

2 (3.5%)
0

1 (1.8%)
1 (1.8%)
2 (3.5%)
2 (3.5%)
2 (3.5%)
3 (5.3%)
3 (5.3%)
3 (5.3%)
1 (1.8%)
2 (3.5%)
1 (1.8%)
4 (7%)
3 (5.3%)
4 (7%)
6 (10.5%)
3 (5.3%)
5 (8.8%)
30 (52.6%)

10

HIV

39 (68.4%)
39 (68.4%)

20
30
40
Number of responses
HBV

50

HCV

Abbreviaons: IR increased risk; NAT nucleic acid tesng; OPO organ procurement organizaon;
OPTN Organ Procurement and Transplantaon Network; TC transplant center

Figure 1: Indications for which OPOs perform nucleic acid

testing on potential deceased organ donors.

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Theodoropoulos et al.

Nucleic acid test result confirmation

Of the responses to questions about confirmation of
positive NAT results, 17/54 (31.5%) OPOs performed
confirmatory testing for all HIV-positive NAT results and 10
(18.5%) confirmed positive results only some of the time,
whereas, 15/55 (27.3%) OPOs performed confirmatory
testing for all HCV positive NAT results and 6 (10.9%) did so
only sometimes. Nine of 43 (20.9%) OPOs performed
confirmatory testing of positive HBV NAT results.

1 (1.8%)
1 (2.2%)
2 (3.6%)

>24 hours

17 (30.4%)
13 (28.3%)
16 (28.6%)
16 (28.6%)
14 (30.4%)
20 (35.7%)
21 (37.5%)
16 (34.7%)
17 (30.4%)

12-24 hours

8-12 hours
4-8 hours
1 (1.8%)
2 (4.3%)
1 (1.8%)

2-4 hours

0
Nucleic acid testing laboratory specifics
Most OPOs are using an out-of-state reference laboratory
to perform NAT (Figure 2A). The lack of an available
laboratory for HBV NAT and HCV NAT was reported by 5
and 2 OPOs, respectively. When asked to name the
laboratory that is used, 17 OPOs named a blood donor
testing center that performed NAT for them. NAT results
were usually received by the OPO within 12 h (Figure 3).
Most OPOs reported they always had the NAT result prior
to the transplant center making a decision to accept the
PDOD for transplantation (Figure 4).
Nucleic acid testing costs and transportation
In 2010, the total amount spent by OPOs on testing PDODs
for HIV, HBV and HCV with serology and NAT was a median
of $135 000 (range $1700$7 014 358). The median cost
for HIV, HBV and HCV NAT per PDOD was $490 ($30

0
2 (3.5%)

5 (9.6%)

6 (10.7%)
4 (7.7%)
6 (10.5%)
7 (12.5%)
6 (11.5%)
7 (12.3%)

OPO on-site

12 (21.4%)
10 (19.2%)
11 (19.3%)
10 (17.9%)
8 (15.4%)
10 (17.5%)

Reference lab in same city

Out-of-state lab

19 (36.5%)

HIV

HBV

OPO on-site

24 (42.9%)
23 (40.4%)

10
15
20
25
Number of responses

30

HCV

6 (10.5%)

Transplant Center

Reference lab in another city

Out-of-state lab
0

Serologic testing
Twenty-one (36.8%) OPOs performed serologic testing
(HIV, HBV and HCV combined) on PDODs using a reference
laboratory in a different state (Figure 2B). When asked to
name the laboratory that is used, 15 (26.3%) OPOs named
a blood donor testing center. When asked if they confirmed
positive serology results for HIV, HBV and/or HCV, 48
(84.2%) OPOs affirmed that they did, 7 (12.3%) OPOs
stated they did not confirm positive results, and 2 (3.5%)
respondents did not provide a response. Of the 40 OPOs
that gave additional information on confirmatory testing, 27
(67.5%) stated they always reflexively performed a
Western Blot for a positive HIV-1/2 enzyme-linked immunosorbent assay (ELISA), whereas three used an immunofluorescence assay. Twenty (50%) OPOs reported they

0
1 (1.8%)
0
0

5
10 15 20
Number of responses

25

*Total will not add to 57 as some OPOs responded with mulple answers

50-75% of the me

1 (1.9%)
1 (1.8%)
2 (3.5%)
1 (1.9%)
2 (3.6%)
16 (28.1%)
13 (24.1%)
16 (28.6%)

75-99% of the me

36 (63.2%)
28 (51.9%)
33 (58.9%)

Always

10
20
30
Number of Responses

Abbreviaons: HBV hepas B virus; HCV hepas C virus; HIV human immunodeciency virus;
NAT nucleic acid test; OPO organ procurement organizaon

Figure 2: Type of laboratory utilized for screening of potential

deceased organ donors. (Panel A) Laboratories utilized for nucleic
acid tests (NAT). (Panel B) Laboratories utilized for serologic
screening tests.

2188

8 (14.8%)

1 (1.9%)
3 (5.3%)
2 (3.7%)
3 (5.4%)

25-50% of the me

21 (36.8%)

HCV

$2976). OPOs report the median NAT transportation cost

per PDOD was $340 ($0$6000). Twenty-six of the 55
(47.3%) OPOs that responded noted they use plane
transportation to laboratories for at least some of their
PDOD screening.

<10% of the me

9 (15.8%)

HBV

25

Figure 3: Nucleic acid test results turn-around times.

Never

11 (19.3%)

10
15
20
Number of responses

HIV

Not applicable
14 (24.6%)

Reference lab in same city

HIV

HBV

40

HCV

Figure 4: Percentage of time that nucleic acid test results are

available prior to transplant decision.

American Journal of Transplantation 2013; 13: 21862190

Survey of OPO Screening Practices

performed a recombinant immunoblot assay (RIBA) to

confirm a positive HCV antibody result, although 1 OPO
noted they only performed a RIBA if a donor is HCV
antibody-positive with a negative NAT result. Seven OPOs
commented that they used NAT alone for confirmation of
positive serologic results.

Discussion
Since the last survey of OPO NAT screening practices
conducted in 2008, more OPOs are using NAT to screen
potential deceased organ donors for HIV, HBV and HCV
(Table 2a). Furthermore, more OPOs are screening all
PDODs with NAT, regardless of OPTN-defined increased
risk status (Table 2b). Importantly, NAT results are usually
now available before the transplant decision is made. These
data also reveal that a minority of NAT results are
confirmed. Considerable variability between OPOs remains
regarding NAT result turn-around time (TAT) and NATassociated costs, particularly related to transportation of
specimens.
The use of NAT to screen PDODs will reduce the possibility
of unexpected transmissions of HIV, HBV and HCV to
transplant recipients by detecting acute or window period
infections, and may also improve the publics opinion on the
safety of organ transplantation (2,9). NAT advocates also
propose that NAT screening could increase utilization of
organs from deceased donors, especially organs from
donors at increased risk for infectious transmission as
defined by OPTN policy (9,11). A 2009 consensus conference endorsed a more limited role for NAT in PDOD
screening because of concern for: (1) loss of donors and
organs due to false-positive NAT results; (2) logistical issues
leading to increased TAT of test results; (3) loss of organs or
increased cold ischemic time due to longer NAT result TAT;
(4) relatively high cost of NAT (9). The data obtained from
this survey updates our knowledge and assessment of the
risks and benefits associated with NAT for PDOD

Table 2a: OPOs performing NAT for screening of potential

deceased organ donors in 2008 and 2010(8)
Year

HIV NAT

HBV NAT

HCV NAT

2008
2010

44/58 (76%)
56/57 (98%)

20/58 (34%)
43/57 (75%)

40/58 (69%)
55/57 (97%)

Table 2b: OPOs performing NAT for screening of all potential

deceased organ donors, regardless of risk status, in 2008 and
2010(8)
Year

HIV NAT

HBV NAT

HCV NAT

2008
2010

30/58 (52%)
39/57 (68%)

14/58 (24%)
30/57 (53%)

28/58 (48%)
39/57 (68%)

American Journal of Transplantation 2013; 13: 21862190

screening. Specifically, the data suggest that nearly all

OPOs have access to prospective NAT and that NAT is
increasingly utilized for screening of all potential deceased
organ donors. Most OPOs have reasonably rapid TAT for
results and most have results available prior to organ offer.
Unfortunately, there is significant variability in the cost of
performing the assays and the cost of the transportation
associated with conducting NAT. Efforts should be directed
at further reducing these costs. Overall, logistical issues
surrounding the use of NAT have improved since 2008 and
future studies can focus on how NAT affects organ
utilization.
Our survey reveals that over half of the OPOs do not
perform confirmatory testing of positive NAT results. This is
likely due to the current lack of a confirmatory algorithm for
the PCR assay. The TMA assay is a multiplex assay which
tests for two (Procleix HIV-1/HCV Assay) or three (Procleix
Ultrio) viruses initially and if positive, requires a second
discriminatory step that determines which of the viruses is
present in the donor sample. This allows for internal
confirmation of an initially positive result. If the initial and
discriminatory results are discordant, the package insert
has an algorithm for repeating the assay. In contrast, there
is no approved confirmatory algorithm for positive PCR
results. Therefore, the test is usually interpreted based on
one result, which could be falsely negative or positive.
Unfortunately, the lack of confirmatory testing of donors
with positive NAT results will inhibit the ability to assess the
impact of non-reproducibly positive (initially reactive with
repeat test result nonreactive) NAT results on organ
availability and utilization. These data suggest that retrospective studies alone will not be able to define the true rate
of non-reproducibly positive NAT results. Instead, funding
will need to be dedicated to conducting prospective studies
that re-test residual specimens on NAT-positive donors and
determine the true rate of non-reproducibly positive NAT
results. Such studies may also inform confirmatory
algorithms for existing assays and help determine which
of the approved assays, TMA or PCR, provides improved
specificity in the setting of deceased donor screening.
The strength of this study is that it captures the most up-todate information on the current practices of deceased organ
donor screening at the 58 U.S. OPOs. The limitations of this
study include those intrinsic to survey studies, such as the
potential for respondent misinterpretation of questions and
recall bias. We did not collect donor-specific details of
costs, TAT and results for all individual donors screened in
this study. Second, as the respondents had the option of
remaining anonymous, we can only say that 57 of the 58
OPOs responded to this survey for certain, although
available data suggests that all OPOs responded to the
survey.
In conclusion, this study provides insight into the current
screening practices of the 58 U.S. OPOs. Most OPOs have
the capacity to perform NAT on PDODs and most are
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Theodoropoulos et al.

performing NAT on all PDODs with acceptable costs and

TAT. Confirmatory testing is infrequently performed on
donors with positive NAT results. Further studies are
needed to define an optimal donor screening strategy.

Acknowledgments
The authors thank the Association of Organ Procurement Organizations
(AOPO), specifically Elling Eidbo and Mark Paster, for their assistance in
distributing our survey. A portion of this work was presented at the American
Transplant Congress, June 26, 2012, Boston, Massachusetts. This work
was funded, in part, through the Northwestern University Transplant
Outcomes Research Collaborative (NUTORC).

Disclosure
The authors of this manuscript have no conflicts of interest
to disclose as described by the American Journal of
Transplantation.

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Supporting Information
Additional Supporting Information may be found in the
online version of this article at the publishers web-site.

American Journal of Transplantation 2013; 13: 21862190