ARTICLE IN PRESS

Transfusion and Apheresis Science ■■ (2016) ■■–■■

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Transfusion and Apheresis Science

j o u r n a l h o m e p a g e : w w w. e l s e v i e r. c o m / l o c a t e / t r a n s c i

A strategical re-thinking on National Blood Donor Pool:

Anti-HBc positivity related re-entry mechanisms
Soner Yilmaz a,*, Aytekin Unlu b, Riza Aytac Cetinkaya c, Mehmet Yapar d,
Ismail Yasar Avci e, Sebahattin Yilmaz a, Can Polat Eyigun f
a Regional Blood Center, Gulhane Military Academy of Medicine, Ankara, Turkey
b Department of General Surgery, Gulhane Military Academy of Medicine, Ankara, Turkey
c
Military Hospital, Isparta, Turkey
d Department of Medical Microbiology, Gulhane Military Academy of Medicine, Ankara, Turkey
e Department of Infectious Disease and Clinical Microbiology, Gulhane Military Academy of Medicine, Ankara, Turkey
f
Department of Infectious Disease and Clinical Microbiology, Sanko University, Gaziantep, Turkey

A R T I C L E I N F O A B S T R A C T

Article history: Background and Objectives: Screening of blood donations for antibodies against hepatitis
Received 20 March 2015 B core antigen (anti-HBc) is used to prevent transfusion transmitted hepatitis B virus (HBV)
Received in revised form 6 October 2015 infection. In this study, we studied the magnitude of blood donor gain by using a re-entry
Accepted 9 October 2015
mechanism in our Blood Bank of Gulhane Military Academy of Medicine.
Materials and Methods: Between January and May 2013, 5148 voluntary blood donors were
Keywords:
screened by ELISA method for HBsAg, anti-HBc total and other screening markers, pro-
Anti-HBc assays
spectively. Samples with repeated reactivity for the presence of anti-HBc were further tested
Transfusion-associated HBV
Blood donor screening with four supplemental assays.
HBV DNA Results: We detected 515 (10%) anti-HBc positive and 4612 (90%) anti-HBc negative cases
Anti-HBs in 5127 HBsAg negative serum samples. A total of 461 (89.5%) blood units were reactive
for at least one additional serologic parameter and 54 were (10.5%) negative. Isolated anti-
HBc positivity rate was 1.3% (69/5127). In the isolated anti-HBc positive samples, 54 were
also anti-HBe and HBeAg negative. HBV DNA was not detected in any of the samples.
Conclusion: Applying the EDQM criteria would decrease our blood donor loss from 10%
to 5.4%. As alternative re-entry mechanisms have already been presented in the litera-
ture, institution of a new policy is needed to enhance the limited blood donor pool in our
system.
© 2015 Published by Elsevier Ltd.

1. Introduction performed in order to prevent infection transmitted by trans-

Hepatitis B Virus (HBV) infection is a serious global health
problem. It is estimated that more than two billion people
have been infected with HBV at some time in their lives, and
350 million are thought to be chronically infected [1]. Mi-
crobiological screening tests for blood donation are
* Corresponding author. Blood Training Center and Blood Bank, Gulhane
Military Academy of Medicine, Ankara 06018, Turkey. Tel.: +90 533 384
47 46; fax: +90 312 304 34 02.
E-mail address: soyilmaz@gata.edu.tr (S. Yilmaz).
fusion. Hepatitis B surface antigen (HBsAg) tests as a
serological marker have been applied in blood donor screen-
ing procedures since 1972 [2]. As a screening test, HBsAg
assays are not sensitive in pre-seroconversion window
period, in the early convalescence period (core window) of
acute hepatitis B infections and in chronic HBV infections,
where HBsAg is often present at low levels. Moreover, HBV
mutants with amino acid substitutions, within the common
“a” determinant of viral gene region, cannot be detected
by the currently available HBsAg screening assays [3,4].
Antibodies to hepatitis B core antigen (anti-HBc) and nucleic
acid tests (NAT) were included in routine microbiological

http://dx.doi.org/10.1016/j.transci.2015.10.004
1473-0502/© 2015 Published by Elsevier Ltd.

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Transfusion and Apheresis Science (2015), doi: 10.1016/j.transci.2015.10.004
 ARTICLE IN PRESS
2 S. Yilmaz et al. / Transfusion and Apheresis Science ■■ (2016) ■■–■■
screening tests to decrease the risk of post-transfusion HBV
infections [4]. The IgM form of anti-HBc occurs within the
first 1–2 weeks after the appearance of HBsAg and per-
sists for 4–6 months. During the core window phase, HbsAg
is cleared and the long lived IgG form of anti-HBc devel-
ops and serves as a useful serological marker for Hepatitis
B infection [5,6]. However, anti-HBc testing would not detect
HBsAg-negative donors in the pre-seroconversion window
period. Due to the slow ramp-up in viral load and the short
diagnostic window period, NAT was expected to require a
very high sensitivity to identify those donors [7].
Inclusion of anti-HBc test in the microbiological
screening tests has been proposed by Food and Drug Ad-
ministration (FDA) in 1991 and successively been
implemented by France, Germany and Japan [6,8]. Imple-
mentation of this test in routine screening programs has also
been recommended for countries with an anti-HBc
seroprevalence of <10% [9]. However, anti-HBc test has a low
specificity rate and this may result in significantly high false
positivity rates. False positivity of anti-HBc tests may be due
to non-specific EIA related reactions, Ig A and Ig M related
substances derived from non-specific HBV-activated B lym-
phocytes or cross reactions caused by various serum-
derived substances [10]. This situation inadvertently leads
to the elimination of anti-HBc test positive donors unex-
posed to HBV from the already limited blood donor pool.
Lack of anti-HBc confirmation tests led to the develop-
ment of re-entry mechanisms to re-gain these test positive
donors.
In this study, we aimed to stimulate the initiatives for
national test algorithms to regain anti-HBc positive donors
in to the donor pool, using the assessment of anti-HBs (quan-
titative), HBeAg, anti-HBe and HBV DNA (PCR) test results.
2. Materials and methods
2.1. Study group
After the approval of Gulhane Military Academy of Med-
icine (GMAM) Ethical Committee, serum specimens from
5148 blood donors, between January and May 2013, were
included in the study. Of these, 4998 (97.1%) were female
and 150 (2.9%) were male. Mean age of the blood donors
was 27.54 ± 9.36. The donor population had not been pre-
viously screened for anti-HBc.
2.2. Serological study methods and test algorithm
Routine screening tests (HIV Ag/Ab combo, anti-HCV,
syphilis TP, HBsAg and anti-HBc total) for 5148 blood donors
were tested according to the manufacturer’s instructions on
an Architect i2000SR (Abbott Laboratories, Abbott Park, IL,
USA) chemiluminescence immunoassay (CLIA). Donors with
HBsAg positivity were excluded from the study. Samples that
yielded repeated reactivity for the presence of anti-HBc was
further tested with four supplemental assays: anti-HBs,
HBeAg, anti-HBe and HBV DNA PCR.
Specimens with concentration values ≥10 mIU/mL are
considered reactive by anti-HBs criteria. HBsAg, HBeAg and
anti-HBe were interpreted using a ratio of the sample rel-
ative light unit (RLU) rate to cut off RLU(S/CO), where
Please cite this article in press as: Soner Yilmaz, et al., A strategical re-thinking on National Blood Donor Pool: Anti-HBc positivity related re-entry mechanisms,
Transfusion and Apheresis Science (2015), doi: 10.1016/j.transci.2015.10.004
S/CO ≥ 1.00 was positive and S/CO ≤ 1.00 was anti-HBe
positive.
An isolated positive test for anti-HBc is defined as the
presence of anti-HBc positivity simultaneously with neg-
ative HBsAg and negative anti-HBs (without further testing
for anti-HBe, HBeAg and HBV-DNA).
2.3. PCR study
Aliquots of 200 μL each of serum samples were tested
by RTA HBV Real-Time PCR Kit version 2.0 on RTA VOLTRAN
Viral Load Detection System, followed by amplification and
detection using Bio-Rad CFX96 Real-Time PCR Detection
System. Quantification of the amount of target in unknown
samples is accomplished by measuring Ct and using the stan-
dard curve to determine starting copy number or IU/mL. RTA
HBV Real-time PCR assay utilizes four external standards to
gather quantitative results. It also includes an internal
control, which controls for target isolation and amplifica-
tion and detected in the HEX fluorescence channel. The
target region is situated in S gene region of HBV genome
and is 104-bases long. The kit has a linear range between
9.9 IU/mL and 1 × 109 IU/ mL; and it can detect HBV DNA
at concentration of 10 IU/mL with a probability rate of 95%
(confidence range is 7.9–14.9 IU/mL). RTA HBV Real Time PCR
Kit can detect and quantify HBV genotypes A, B, C, D, E, F,
G and H; and no cross-reactivity has been observed with
other potential cross-reactive markers (RTA HBV Real-
Time PCR Kit v2.0 Handbook, 2014). The assay has the
Conformite Europeenne/European Conformity – In Vitro Di-
agnostic Medical Devices (CE-IVD) approval (Notified Body
number: 0483).
2.4. Statistical analysis
Data analysis was performed with computer software
(SPSS, Version 15.0, SPSS Inc., Chicago, IL). Frequencies and
percentages were computed to present test positivity. Age
of blood donors was presented as mean ± SD.
3. Results
Out of 5148 blood donors, 536 had anti-HBc positivity.
HBsAg was detected in 21 of 536 donors and these donors
were excluded from the study. The remaining anti-HBc pos-
itive 515 donors were investigated for the presence of HBV
DNA by using the PCR method and the additional sero-
logic markers (anti-HBs, HBeAg, anti-HBe).
Among 515 anti-HBc positive donors, 446 had anti-
HBs titers ≥10 mIU/mL. In serum samples of 446 anti-HBs
positive donors, 238 (46.2%) were highly positive (100 ≥ mIU/
mL) and 208 (40.3%) were low positive (<100 mIU/mL)
(Fig. 1). The isolated anti-HBc positivity rate was derived
from the remaining 69 (1.3%) donors. Within the 515 anti-
HBc total positive donors, 201 (39%) were anti-HBe positive.
Of the 201 anti-HBe positive donors, 186 (93%) were tested
positive for anti-HBs.
All of the HBeAg test results were negative. The exact se-
rologic profile of 515 anti-HBc positive blood donors is
shown in Table 1. None of the anti-HBc positive donors had
HBV DNA positivity.

30
Percentage of anti-HBc total
25
positive samples
20
15
10
0
4. Discussion
In Turkey, HBsAg has been used as microbiological
screening test to prevent transfusion related HBV infec-
tions, since 1983 [11]. However, in order to increase the
blood safety program, there are no legal restrictions for the
use of various tests, such as anti-HBs, HbeAg and/or NAT
tests. Anti-HBc test has been used by Regional Blood Center
of GMAM as a screening test since January, 2013. Thus,
donors tested positive for anti-HBc have not been ap-
proved for blood donation in our center.
HBV transmission is possible in case of isolated anti-
HBc positivity (HBsAg and anti-HBs negative) or concomitant
anti-HBs positivity [4,12]. Special cases that cause isolated
anti-HBc positivity are recovery from an acute infection,
immune from an earlier infection with undetectable levels
of anti-HBs and low grade chronic infection when HBV DNA
is below detection levels [13]. During the later stages of HBV
infection, HBV DNA levels are extremely low and that se-
rologic screening, rather than NAT screening, maybe more
effective for the detection of chronic carriers. Studies show
that 0.5–1.0% of anti-HBc-positive, HBsAg-negative dona-
tions contain very low HBV DNA levels, which are unlikely
to be detected by pooled-sample NAT or even single-
donor NAT [14]. Kosan et al. investigated the applicability
of NAT for HBV screening and showed that HBsAg-negative
and NAT positive; 11 of 11 cases were found to be anti-
HBc positive [15].
Table 1
Serologic profiles of anti-HBc total positive individuals.
Serologic markers Number
positive
Anti-HBc (+), anti HBs (+), 260
anti-HBe (−), HBeAg (−)
Anti-HBc (+), anti HBs (+), 186
anti-HBe (+), HBeAg (−)
Anti-HBc (+), anti HBs (−),
anti-HBe(−), HBeAg (−)
Anti-HBc (+), anti HBs (−),
anti-HBe (+), HBeAg (−)
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S. Yilmaz et al. / Transfusion and Apheresis Science ■■ (2016) ■■–■■ 3
Negative Low positive High positive
(n=69) (n=208) (n=238)
0-<10 >10-50 >50-100 >100-200 >200-1000 >200-1000
Anti-HBs levels (mIU/mL)
Fig. 1. Anti-HBs levels in anti-HBc total test result positive individuals.
In our study, isolated anti-HBc positivity rate was 1.3%.
In the literature, the reported isolated anti-HBc positivity
rates show huge variations between geographical loca-
tions, which vary between 3.7% and 19.8% [13,16,17].
Countries of particular concern are the US and Europe that
already have low HBV endemicity and their positivity rates
have been reported as 1–4% [18]. In our country, isolated
anti-HBc positivity rates seem to vary between 2% and 5.1%
[19–21]. The isolated anti-HBc rates, which are lower than
the rates reported in national studies, are probably due to
national vaccination program, blood safety policies estab-
lished and serological tests with higher specificity rates.
In the presence of HBV DNA positivity, isolated anti-
HBc positivity increases the risk of HBV virus transmission
to blood recipients. In some studies, HBV DNA positivity rates
of isolated anti-HBc positive blood donors have been re-
ported as 24.4%–30% [22–24]. Interestingly, other studies
have demonstrated extremely low (0%–0.91%) positivity rates
[20,21,25,26]. The current study also showed no HBV DNA
positivity among isolated anti-HBc positive donors. The dis-
cordances between the above mentioned studies may
depend on the epidemiological differences between the in-
vestigated populations, sample selection criteria for PCR
testing and differences in sensitivity and specificity of NAT
methods, which promote great disparity in HBV DNA test
results [10]. The PCR method used in the current study has
a lower sensitivity limit of 10 IU/L which is within the safety
limits set by Paul Ehrlich Institute [8].
The above data stressed on the crucial role of anti-HBc
positivity on HBV transmission to recipients in blood banking
settings. However, the major point seems to be the assess-
ment of the significantly high false positive anti-HBc rates.
Percentage Studies proved that the reported positives can signifi-
(%) cantly be attributed to false positivities, which may be as
50.5 high as 40.4% and 60.6% in different studies [5,8]. In re-
sponse to the high positivity rates, various re-entry
36.1
mechanisms to prevent donor loss have been developed
54 10.5 in countries that mandate anti-HBc test among the micro-
biological screening tests. In the absence of accurate
15 2.9 complementary tests to confirm isolated anti-HBc positiv-
ity, the re-entry mechanisms of choice vary between
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Table 2
Application of our results to other studies which researched different re-
entry mechanisms.
Studies Our applied re-gain rates, % (n)
Schmidt et al. [5] 314 (3.9%)
EDQM criteria [27] 238 (5.4%)
Sato et al. [28] 182 (6.5%)
concerned countries. German Advisory Committee Blood rec-
ommended re-entry of anti-HBc positive donors with
negative ID-NAT and anti-HBs titer above 100 IU/L. Hourfor
et al. showed that the established re-entry mechanism in
Germany decreased their donor loss from 1.75% to 0.45% [6].
According to the The European Directorate for the Quality
of Medicines& HealthCare (EDQM) criteria, re-entry of anti-
HBc positives should have anti-HBs titers of at least 100 IU/L
and each subsequent donation should be analyzed with ap-
proved assays and tested negative for HBsAg and HBV DNA
[27]. In accordance with the EDQM criteria, our isolated anti-
HBc positivity related donor loss would decrease from 10%
to 5.4%, which totals to a gain of 238 donors.
Another re-entry mechanism is the confirmation of anti-
HBc positivity as an indicator of a past HBV infection has
not yet been established. It is likely that anti-HBc positiv-
ity, concomitantly with both anti-HBs and anti-HBe, suggest
a past HBV infection. Anti-HBe positivity alone may also
suggest a past HBV infection [5]. In our study, of 515 anti-
HBc positive donors 186 were also anti-HBs and anti-HBe
positive, 15 were only anti-HBc and anti-HBe positive, which
totaled to 201 blood donors. These donors must be re-
garded as true positives according to the above mentioned
re-entry mechanism. This emphasizes the regain of 314
blood donors to the donor pool in our study (donor loss ratio
decrease from 10% to 3.9%). In Japan, results gained from
anti-HBs titrations were reported to be parallel to the risk
for the presence HBVDNA and they approved the re-entry
of anti-HBc positive donors if their anti-HBs levels were
above 200 mIU/L [28]. These criteria would permit the regain
of 182 donors in 515 in our study, a decrease of donor loss
from 10% to 6.5%. Application of our results to other studies
which researched different re-entry mechanisms is sum-
marized in Table 2.
In the US, FDA suggests re-testing of anti-HBc positive
donors after a period of 8 weeks by using FDA approved
HBsAg, anti-HBc and NAT tests, disapproval of donors if any
of those re-test results are positive and approval of donors
in the re-entry mechanism if all re-tests are negative [29].
In studies from Germany and Switzerland, results suggest
re-testing of anti-HBc positivity by other anti-HBc kits and
approval of donors into re-entry mechanism. Juhl et al. re-
ported 38.7% re-gaining of blood donor loss by the use of
more specific anti-HBc test [8]. In this context, another study
showed a 61.5% re-gain rate by using the positive test results
of two different test kits [30]. However, these alternative re-
entry mechanisms were not included in our study design
and re-gain rate could not be determined and shall be subject
to future studies for establishing better national re-entry
policies.
To our knowledge, the current study is the first study that
investigates anti-HBs levels for blood donor re-gain. In the
Please cite this article in press as: Soner Yilmaz, et al., A strategical re-thinking on National Blood Donor Pool: Anti-HBc positivity related re-entry mechanisms,
Transfusion and Apheresis Science (2015), doi: 10.1016/j.transci.2015.10.004
United States, a comprehensive study investigated data from
3350 blood donors positive by two anti-HBc assay systems
showed that anti-HBs negativity rate was 12%, the anti-
HBs titers were below 100 IU/L in 25%, above 100 IU/L in 63%
of donors [31]. In UK, another study showed the above men-
tioned rates were 12%, 17% and 71%, respectively [32]. When
compared to these international studies, our results were
similar. The current study does not involve HBV vaccina-
tion history of donors, which could provide more insight
to criticize these results.
Turkey lacks adequate blood resources, and anti-HBc
positivity related rejection of blood donors further com-
plicates the issue in the absence of a valid re-entry
mechanism. Establishing a re-entry mechanism with anti-
HBc screening tests may prevent unnecessary donor loss and
also increase blood safety. Until the application of NAT test
for donor screening becomes widely available, the EDQM
criteria seem to be a feasible and promising alternative to
alleviate current burdens in blood supply.
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Transfusion and Apheresis Science (2015), doi: 10.1016/j.transci.2015.10.004
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