Biologicals 38 (2010) 59–64

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Biologicals
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Nucleic acid testing (NAT) in high prevalence–low resource settings

Magdy El Ekiaby a, *, Nico Lelie b, Jean-Pierre Allain c
a
Shabrawishi Hospital Blood Transfusion Center, Finni Square, Dokki, Giza, Egypt
b
Chiron, Novartis Vaccines & Diagnostics SAS, 10 Rue Chevreul, Suresnes, France
c
Department of Haematology, University of Cambridge, Cambridge, UK

a r t i c l e i n f o a b s t r a c t

Article history: Blood screening by NAT for major transfusion transmitted viral infections (TTIs) was originally intended
Received 23 October 2009 to complement serology for detection of infected donations. Reports from developed countries showed
Accepted 23 October 2009 limited marginal value to NAT blood screening in improving blood safety. Reports on NAT results from
Europe indicated yield of 1:0.6 million donations for HBV, <1:M for HCV and HIV-1-related to low
Keywords: prevalence of TTI. In contrast, prevalence of TTI in resource-limited countries is almost always high. As
Nucleic acid testing
a result, more incident cases can be expected among first-time blood donors. Most reports of NAT blood
NAT
donation screening in these countries showed NAT confirmed yield as high as 1/2800 for HBV and 1/3100
HIV
HBV blood donations for HCV as reported from Thailand and Egypt, respectively. The issues for low resource
HCV countries are mostly the high cost of NAT but also the requirements of staff qualification, adequate
Developing countries facilities, reagent procurement and maintenance of delicate equipment. Alternatives to commercial NAT
are the use of combos antigen-antibody for HIV and HCV, anti-HBc for HBV and in-house NAT. Most of
these alternatives have been reported but very few comparisons are available. Once yield data is avail-
able, models for estimation of feasibility and cost-effectiveness are proposed to help decision-making.
Ó 2009 The International Association for Biologicals. Published by Elsevier Ltd. All rights reserved.

1. Introduction period at the time of donation is generally very low. Only in

NAT blood screening for key TTIs was originally intended to
complement serological screening for detection of donations
infectious for those viruses. The main advantage of NAT screening is
interdiction of new incident cases during the window period
infections. An additional benefit, which was identified as a result of
accumulated experience of the use of the NAT was the identifica-
tion of occult hepatitis B carrier status, which can potentially be
infectious. Most populations in resource-limited regions suffer
from high prevalence rate of these TTIs, and are expected to have
more frequent incident cases, as well as more occult carriers.
Consequently NAT screening of TTIs in these populations would be
expected to identify more yield cases as compared to the developed
world and thus to be more cost-effective.
The introduction of NAT should be considered only when an
efficient and effective program of serological testing is in place [1]
and there is clear evidence for additional benefits of NAT. Although
NAT reduces the window period of infection, in many cases the
incremental gain is minimal as the actual reduction in the window
period may be very small and the number of donors in the window
countries with a high prevalence and incidence of infection are
likely to yield a significant number of window period donations.
Thus although the risk of transfusing a blood unit collected during
the window period may be decreased using NAT, the actual benefit
in most populations should be determined and balanced against
the complexity and high cost of setting-up, performing and
sustaining NAT [2–4].
The implementation of NAT blood screening at the national or
blood establishment level requires an appropriate infrastructure,
defined test algorithm, existing quality assurance and quality
control, confirmatory assays for reactive results, management
procedures for donors with confirmed positive test results. In
addition, an evaluation of cost-effectiveness should be performed
before considering such a screening program. Several developing
countries have recently implemented NAT screening and have
published their experience and presented their conclusions on the
value of this strategy according to locally or nationally defined
criteria. This review summarizes these experiences and their
conclusions.
1.1. Blood screening program for TTIs

* Corresponding author. Tel.: þ20 2 338 4684; fax: þ20 2 3338 4679. A screening program may be developed to implement the
E-mail address: elekiaby@tedata.net.eg (M. El Ekiaby). national policy on blood screening to identify and prevent the

1045-1056/$36.00 Ó 2009 The International Association for Biologicals. Published by Elsevier Ltd. All rights reserved.
doi:10.1016/j.biologicals.2009.10.015
60 M. El Ekiaby et al. / Biologicals 38 (2010) 59–64
release of any donations reactive for specific TTIs using the most
reliable and cost-effective approach [5]. As a general philosophy, it
is understood that for any country, particularly those with scarce
resources, the most important priorities should be considered. First
is the adequacy of the blood supply for patient requirements. There
is no definitive number establishing the extent of such need but in
developing countries where most blood demand is for emergency
indications of massive blood loss or acute anemia, a supply ranging
between 10 and 20 units/1000 inhabitants is generally cited.
Second, this blood should be as safe as possible within the limits of
affordability. Depending on resources, blood testing might be only
for anti-HIV, or anti-HIV and HBsAg or for all three main markers
(HIV, HBV, anti-HCV). The use of combo antibody/antigen to
improve HIV or HCV safety depending on local epidemiology can be
considered at relatively modest increase in costs over antibody
testing alone. Envisaging the introduction of NAT requires a number
of preliminary steps described below. These include: (1) defining
local or regional epidemiology; (2) performance of pilot studies to
generate data as well as to establish operational and financial
parameters; and (3) determination of strategy taking into consid-
eration not only technical and operational issues but most impor-
tantly cost-effectiveness. These preliminary steps usually imply the
existence of a national blood policy that should address national
requirements for the screening of whole blood and apheresis
donations prior to their release for clinical or manufacturing use.
Such a policy should define mandatory screening for specific
infections markers and screening for other TTIs, based on national
epidemiological data on blood-borne pathogens. It should also
outline the measures taken to ensure that all screening is per-
formed in the context of effective, quality-managed blood trans-
fusion services and require the most efficient use of available
resources. The need for, and the role of, confirmatory testing should
also be clearly defined.
2. National blood collection and screening strategy
Blood safety depends on donor selection and donor/blood
testing. In areas of high prevalence of viral infection, donor-
dependent blood safety may rely more upon assuring repeat
donation than on the classical distinction between volunteer and
replacement donors. Laboratory screening of blood donations is the
second step that determines whether or not a donor or a donation
are non-reactive for specific markers of infection and blood is
therefore safe to release for clinical or manufacturing use. In most
cases, laboratory screening is performed after the blood donor
selection and the donation process. The expectation is that the
majority of the donations collected would be from healthy, unin-
fected, individuals and would be non-reactive. However, some
donations will be repeat reactive and procedures must be in place
to distinguish between true and false reactivity by the process of
confirmation.
Consideration should also be given to the management of
donors who are deferred after their blood is reactive in screening
tests and deferred and then of those confirmed infected. Reliable
confirmation of screening reactivity is essential, helping both in the
management of donors and in the understanding of the epidemi-
ological profile of blood-borne infections in the donor population.
In addition to the screening strategy, the blood screening program
should define the confirmation algorithm for repeat reactive test
results. Each country must decide on the TTIs to be tested as part of
the blood screening program and select a screening strategy
appropriate to its specific situation. This will be influenced by the
incidence and prevalence of infection, the costs of testing,
the capacity and infrastructure of the blood transfusion service and
the available resources.
3. Collecting epidemiological evidence
Epidemiological evidence should be collected on a relatively
large, representative, cross-section of the donor population
including first-time volunteer and replacement donors, as well as
repeat donors. In many areas, only screening data is available but
this may not provide accurate information as only confirmed
positive results are informative. For antibody or antigen assays,
reactivity with two separate assays is the minimum approach for
confirmation, particularly where prevalence is high. When
combo assays are used, the presence of antigen only (separate
antibody assay negative) indicates window period infections,
which can be used to determine the incidence of infections. The
next step would be to collect NAT data, within or prior to
the pilot stage to determine the potential added efficacy of the
method. NAT data collected with a Triplex system provides data
on HIV, HCV and HBV in a single study. For HBV safety, identi-
fying window period infection is important but it is also impor-
tant to detect HBV DNA in HBsAg negative, anti-HBc positive
donations. The alternative strategy for additional HBV safety is
screening for anti-HBc. This approach may lead to discarding
large proportions of donations unless anti-HBc positive samples
are also tested for anti-HBs and only donations without anti-HBs
or with anti-HBs titer <100 IU/L are discarded. In such circum-
stances, the cost of discarding collected units and of recruiting
new donors to compensate for such loss of supply as well as the
percentage of repeat donors have to be taken into consideration
in the costing of the strategy [6–8]. For instance, a unit of blood
may cost $20 in Sub-Saharan Africa when collected mostly from
replacement donors, $50 in India or in African centralized
volunteer only systems, making these estimations widely
different. Preliminary calculations indicate that at a $20 blood
cost, NAT becomes cost-effective above 30% anti-HBc positive
units but at 15% discard rate when blood cost reaches $50 or
above (van Hulst, personal communication).
4. Pilot phase
The pilot phase is critical as it provides not only the addi-
tional epidemiologic data needed but also an evaluation of the
technology(ies) available, exposure of staff to equipment and
methods, assessment of algorithms for screening and confir-
mation, and defines the changes in facilities and operations
created by the new method. In some cases such as in Thailand,
Hong Kong or Taiwan, both commercial triplex assays were
successively or concomitantly evaluated [9–11]. In these three
countries, centralized high throughput systems were already in
place and some funding was available for the evaluation. As
HBV was the only high prevalence infection, screening in pools
of six to eight or in individual unit samples revealed differ-
ences in the frequency of yield cases both window period and
occult HBV infection (OBI) as well as in the frequency of HBsAg
confirmed positive cases negative for HBV DNA. The data were
then presented to the authorities for decision-making in which
both testing efficacy and cost of screening were taken into
consideration. In other evaluations, only one assay was
assessed, either commercial or in-house [12–15]. In situations
where resources and expertise are limited, it may be appro-
priate to utilize evaluation data from external sources to assess
potential assays and systems. In all cases, however, it is
essential that an effective process is defined and put in place to
ensure that new assays and systems are considered and
possibly introduced only following extensive investigation,
evaluation and validation.
 M. El Ekiaby et al. / Biologicals 38 (2010) 59–64
5. Laboratory quality systems
Effective quality systems are essential for the overall effective-
ness of the blood screening program and to prevent the trans-
mission of infection through transfusion. Quality systems should
not be limited to laboratories only but should encompass all BTS
activities to ensure that all donations are screened correctly and
handled appropriately before and after laboratory testing. For
instance, in blood services where the number of blood samples
collected is modest, screening is performed at several day intervals
during which part of the blood stock is quarantined. The distur-
bances of such quarantine might create for storage of blood and to
the blood availability must be carefully evaluated. Meeting defined
quality standards will ensure the safety and clinical efficacy of
blood and blood products as well as protecting the health and
safety of all staff that come into contact with them.
6. Human resources
A sufficient number of qualified, trained and competent staff
should be available to perform the laboratory activities associated
with blood screening, including the implementation of quality
systems. Such training prior to the pilot phase of the evaluation will
be provided either on site supervised by commercial company staff
or, probably more effectively, through in depth training in an
external laboratory for people already knowledgeable in molecular
biology would be very beneficial as it would provide the blood
center with new skills that may be applied to a range of targets.
During the weeks required for such training, not only the screening
method(s) but also methods for confirmation and in depth under-
standing of the methodologies involved is needed as most of the
time, staff will be without external support when problems occur.
Continued support by electronic communication for data inter-
pretation or technical issues by the specialists at the training site
are often psychologically and technically very helpful. Blood
transfusion services would benefit from working with national
health and education authorities to ensure that education and
training institutions provide suitable opportunities for staff quali-
fication and training. In-service training programs established and
reviewed at appropriate intervals and measures adopted to retain
experienced staff will help to ensure that laboratories function
effectively.
7. Financial resources
Experience has demonstrated that in terms of blood safety,
either economic or political criteria are usually critical in the
decision-making process. It is therefore essential that detailed and
evidence-based information be given to the decision-making
bodies. Recently, several articles have been published examining
cost-effectiveness issues related to HIV and HBV blood safety since
they are the most critical in most developing countries. The case of
Egypt is unique since HCV is the most frequent infection in blood
donors. The Working Party on Infectious Diseases of the Interna-
tional Society of Blood Transfusion has developed a program which
uses the input of basic operational and epidemiologic information
to determine the cost-efficiency of a given intervention. Prelimi-
nary results obtained with this program indicated that HIV NAT in
Ghana where the prevalence is around 4% in the general population
and 2% in blood donors was not cost efficient [16]. In contrast, it
demonstrated that an in-house Triplex NAT in pools of 10 samples
following pre-donation screening for anti-HIV, anti-HCV and
HBsAg performed with rapid tests was more cost efficient than
microtiter plate EIAs (Van Hulst, 2009, submitted). One of the main
uncertainties in the assessment of cost-efficiency is the infectivity
61
of HBV outside of the window period. The implementation of new
systems for screening is best undertaken in a stepwise fashion with
appropriate data collected, cost-effectiveness calculated and
resources allocated for establishing long-term operations and
quality systems [16].
8. Procurement and supply of test kits and reagents
Once the decision is made to implement a strategy including
NAT, continuity in the supply test kits, reagents and consumables
required for quality testing depends on reliable procurement and
supply systems is needed. Interruptions in the supply of test kits
and reagents may result in the temporary inability of screening
facilities to screen for TTIs thus resulting in issuance of unscreened
blood for transfusion. Similarly, maintenance of the delicate
equipment required to perform the assays needs to be assured.
Formal procurement processes, where appropriate using existing
national procurement systems are recommended to ensure the
sustainability of the screening program. A reliable procurement and
supply system not only benefits the BTS, but also ensures that each
supplier is fully aware of the test kits and reagents required, the
usage rates and the quantities needed. Transportation and storage
of reagents (some of them need to be kept frozen), particularly
during airport transit in tropical conditions can be a challenging
problem. The manufacturer and the BTS should ensure that reliable
cold chain systems are in place to assure compliance at all times
[17,18].
9. Testing approaches
9.1. Commercial and In-house NAT blood screening assays
Since the late 1990s several European blood centers imple-
mented NAT blood screening. These centers used either in-house or
commercial assays. The technologies used were either direct and
reverse transcription-mediated amplification by polymerase chain
reaction (PCR) or transcription-mediated amplification of particular
genome sequences. In-house assays must be carefully validated,
should include positive, negative, and internal controls and should
always be monitored by the use of external quality assurance
panels [19]. In contrast to the situation in developed countries, in
many developing countries, no specific requirements are in place to
make commercial assays mandatory. In-house assays can be more
easily implemented at a fraction of the cost offered by western
commercial companies. However, as mentioned above, assay
quality and quality assurance rules must be equally applied all
assays whether commercial or in-house.
9.2. NAT blood screening experience in resource-limited countries
Several resource-limited countries have implemented NAT
blood screening either on a national or center level. For example,
the Thai National Blood Center collected 486,676 seronegative
blood donations in 2007 tested by NAT using the Novartis TIGRIS/
Procleix Ultrio test and the Roche Cobas s 201/Cobas TaqScreen
multiplex (MPX) test (Table 1). The NAT yield rate for human
immunodeficiency virus Type 1 (HIV-1), hepatitis C virus (HCV),
and hepatitis B virus (HBV) was 1:97,000, 1:490,000, and 1:2800,
respectively. A majority of occult HBV infections, detected by both
tests, were identified. HIV-1 and HCV window period cases were
detected with both tests [9]. In Taiwan (which is not a developing
country but a country with high HBV infection rate) among 10,727
seronegative donations, 12 HBV NAT yield cases (0.11%) and one
HCV NAT yield case (0.01%) were detected. Follow-up results for 1–
8 months showed that the HCV yield case was a window case and
62 M. El Ekiaby et al. / Biologicals 38 (2010) 59–64

Table 1
Pilot studies of Triplex NAT in four blood centers in four developing countries.

Country Author Dominant Serology NAT Mode N samples Seroþ/ Seroþ/ Sero-/ WP infection
genotypes NATþ DNA DNAþ
South Africa Vermeulen [20] A1/D HBV Ultrio ID 732,250b 358 17 14 4
C HIV 483 2 4
5 HCV 24 3 0
Thailand Nantachit [14] B/C HBV Ultrio ID 5083 268 10 7 0
CRF-AE HIV 13 0 0
3 HCV 34 0 0
Thailand Phikulsod [9] B/C HBV Ultrio ID 486,676 126 94 24
CRF-AE HIV S201 MP6 5
3 HCV 2
Ghana Owusu-Ofori E HBV In- MP10 5109 13 13 0
[15] house
E HBV ID 709 17 0 12 0
CRF02_AG HIV 0
2 HCV 0
Egypt El Ekiaby [22,23] D HBV Ultrio ID 15,655 164 23 6 0
HIV 0 0
4 HCV 444 130 5

all HBV NAT yield cases were occult carriers. The authors concluded
that Triplex NAT detected occult HBV and reduced the HCV window
period. The yield rate, especially occult HBV, was 10- to 100-fold
higher than that in developed, HBV non-endemic, countries.
Therefore, NAT implementation for routine donor screening in
a more cost-effective manner should contribute to safer blood
transfusion in Taiwan [10].
In South Africa, NAT and serology yield rates in first-time,
lapsed, and repeat donors were analyzed (Table 1). The HIV, HBV,
and HCV ID-NAT window phase yield rates in 732,250 blood
donations tested as single samples were 1:45,765, 1:11,810, and
1:732,200, respectively [20]. In Ghana, an in-house Triplex NAT for
HIV-1, HCV and HBV in pools of 10 individual plasmas has been
evaluated in a pilot mode in over 5109 samples seronegative after
pre-donation serological screening with rapid tests (Table 1) [15]. In
this case, NAT identified not only samples missed by the HBsAg and
anti-HCV rapid test initial screening but also 1:400 occult HBV
cases. This rate increased to 1:60 when tested in individual dona-
tions. Of note, Ghana is one of the countries in the world with the
highest rate of HBV seropositivity (80%) and chronic HBV infection
(15%). Despite a 4% prevalence of HIV infection in the general
population (2% in blood donors), no HIV window period infections
were identified.
In Brazil, an ‘‘in-house’’ RT-PCR method was developed that
allows the simultaneous detection of the RNA of HCV and an
external control. Samples were analyzed in pools of six to 12
donations, each donation included in two pools, one horizontal and
one vertical, permitting the immediate identification of a reactive
donation, obviating the need for pool resolution. The whole process
took 6–8 h and results were issued in parallel with serology. The
method was shown to detect all six HCV genotypes with a sensi-
tivity of 500 IU/mL. Until July 2005, 139,678 donations were tested
and 315 (0.23%) were found reactive for HCV RNA. Except for five
false–positives, all reactive samples were also antibody positive and
no WP donations were identified (Table 2). Detection of WP
donation in the population studied would probably require testing
of a larger number of donations [12]. This method detects all HIV-1
group M subtypes, plus group N and O, with a detection threshold
of 500 IU/mL. After validation, the method replaced p24 Ag testing
which had been in use for blood donation screening since 1996.
From July 2001 to February 2006, 102,469 donations were tested
and 41 (0.04%) were found HIV-RNA reactive (Table 2). One window
period infection was observed giving a yield of 1:102,469 [13].
In Mexico an exploratory comparison of the performance of the
standard immunoassay-based screening tests for the HBV and HCV
and NAT, in blood donations was conducted [26]. From January
1999 to March 2005, 94,806 blood donors were screened for anti-
HCV antibodies and for hepatitis B surface antigen (HBsAg).
Molecular screening was performed on 100 consecutive blood
donations to detect HBV DNA and HCV RNA by home-made PCR

Table 2
Pilot screening for single virus by NAT in blood donors from developing countries.

Country Author Dominant genotypes Serology NAT Mode N samples Sero-/NATþ NAT yield
Brazil Wendel [12] 1 HCV In-house MP6–12 139,678 0
Brazil Levi [13] B HIV In-house MP6–12 102,469 1
Mexico Chiquete [20] D/F HBV In-house ID 100 1
Mexico Chiquete [20] 1 HCV In-house ID 100 1
Mexico Garcia-Montalvo [26] HBV In-house ID 11,240 >13 <1:865
Lebanon El-Zaatari [27] D HBV In-house ID 5511 11 1:501
Lebanon Ramia [28] D HBV In-house ID 2505 7 1:358
Mongolia Tsatsralt-Od [29] D HBV In-house ID 403 5 1:81
China Ren B/C HBV S201 MP8 14,305 10 1:1430
Malaysia Lam B/C/D HBV Ultrio ID 43,393 12 1:3,616
India Makroo [7] D HBV Ultrio ID 12,224 6 1:2037
C HIV Ultrio ID 12,224 2 1:6112
1/3 HCV Ultrio ID 12,224 1
Chaudhuri [30] D HBV In-house ID 24,674 >40 <1:617
Iran Behzad-Behbahani [6] D HBV In-house ID 2000 16 1:125
Kuwait Al Radwan D HBV In-house 121,384 5 1:24,275
Pakistan Bhatti [31] D HBV In-house ID 966 5 1:193
Mozambique Cunha [32] A1 HBV In-house ID 1577 23 1:69
 M. El Ekiaby et al. / Biologicals 38 (2010) 59–64
techniques without sample pooling. In the 75-month period of
serologic screening, HBsAg was detected in 219 donors (0.23%; 95%
CI, 0.20–0.26%) and anti-HCV antibodies in 922 (0.97%; 95% CI,
0.90–1.03%). The annual trend for HBsAg prevalence had a signifi-
cantly decreasing pattern over the years, whereas that for anti-HCV
did not. In the molecular screening of seronegative samples, HBV
DNA was detected in one donor (1%) and HCV RNA in another (1%).
Conclusion was that NAT can detect cases of HBV and HCV infec-
tions that standard immunoassay techniques cannot, even in
a highly selected population such as blood donors. Large-scale
studies are warranted for NAT to be considered as a method for
routine screening of HBV and HCV in Mexican blood banks [21].
As shown in Table 2, a relatively large number of preliminary
studies of NAT applied to blood donors in developing and high
prevalence countries have been published. Most studies targeted
HBV because of its high prevalence in many areas. The frequency of
HBV DNA in HBsAg seronegative blood donations was as high as
1:69 in Mozambique. These numbers however do not distinguish
between different donor populations, particularly between repeat
and first-time donors. Only three studies addressed HIV or HCV
NAT testing and yield was generally low.
While most reports on NAT blood screening in resource-limited
countries have focused on the NAT yield in serology negative blood
donors, there were no studies comparing the possible three
scenarios of NAT only yield, NAT/serology concordant yields and
serology only yield in a cohort of blood donors. A recent study
conducted in Shabrawishi Blood Transfusion Center, Cairo, Egypt
compared the NAT (Procleix Ultrio ID_NAT on Tigris, Chiron,
Novartis) and serology (CLIA on Architect, Abbott) yields by
screening 15,655 first-time blood donors for both. While HIV yield
was identical by both NAT and serology, there were differences in
yield cases of HBV and HCV. Egyptian blood donors tested for
HBsAg and HBV DNA in individual donations (ID) identified 187
(1.2%) HBV infections: 164 (87.7%) both HBsAgþ/HBV DNA reactive
and 23 (12.3%) HBsAgþ/HBV DNA non-reactive (anti-HBcþ/anti-
HBeþ). The medium (and range) of HBV DNA and HBsAg concen-
trations in the 23 NAT-negative carriers was 3.4 cps/mL (<1–230)
and 22 ng/mL (0.3–6253), respectively. Sequencing indicated all
samples to be wild type genotype D. The sensitivity of Q-PCR,
ULTRIO Plus and Taqscreen was similar. The estimated risk of HBV
transmission by ULTRIO Plus screened RBCs was reduced to 0–13%
in 17/23 donations with viral load <25 cps/mL [22].
In the same population of first-time donors 701 (4.5%) were
reactive to either HCV antibody or RNA. HCV Ab and ID-NAT reac-
tivity of 444 samples (63,3%) were concordant, five samples (0.7%)
were only ID-NAT reactive and probably WP infections and 252
(35,9%) were anti-HCV CLIA reactive, but ID-NAT non-reactive of
whom 130 (18.5%) had anti-HCV S/CO > 2.0. For red cell trans-
fusions of first-time Egyptian donors the residual HCV transmission
risk was estimated to be 1:3100 or 1:89,800 if anti-HCV CLIA or ID-
NAT alone was used, respectively. The residual risk after combined
anti-HCV screening and ID-NAT was estimated at 1:150,000 [23].
10. Discussion and conclusions
Reports from developed countries have shown the limited value
of NAT blood screening in improving blood safety. The Scottish BTS
reported a NAT yield rate for HIV and HCV of 1 per 1.9 and 0.77
million donations [18]. Reports on NAT yield of screening 3.6
million blood donations from continental Europe for HBV, HCV and
HIV-1 were 1 per 0.6 million donations for HBV, HCV and 1 per 1.9
million for HIV-1 [24,25]. This is primarily due to the low preva-
lence of HIV-1, HBV and HCV in these countries. In contrast to this,
the prevalence of these viral infections in resource-limited coun-
tries is generally high. In these circumstances, more incident cases
63
can be expected among first-time blood donors. Most of the reports
of NAT screening in these countries showed NAT yield cases as high
as 1:60 blood donation [15] for HBV and 1/3100 blood donations for
HCV [23]. Also of importance in the consideration of NAT blood
screening in resource-limited areas is the importance of assessing
infectivity for HCV and HBV [22,23]. While these reports and their
projections suggest to support recommending the use of the NAT
blood screening in resource-limited countries, there are many
critical elements to carefully evaluate before any recommendation
can be made. The level of development of the blood services in
these countries and their ability to adapt this complicated and
expensive technology as well as its integration in the general blood
service is very challenging. Most importantly, cost/effectiveness
and affordability of implementation are paramount in making such
decision.
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