International Journal of Seocology

(Science, Education, Economics, Psychology and Technology)

Overview of Hepatitis B Virus Exposure on NAT and CLIA Blood

Examination Methods at PMI Semarang City

Rina Puspita

Politeknik Bina Trada Semarang, Indonesia

Corresponding email: rinapuspita0980@gmail.com

Abstract:
There are 421 blood bank in Indonesia, only 12 blood bank used NAT method to test
transfusion transmitted disease. Whereas NAT is a moleculer test is recommended by
WHO to detect window period. These study is to describe transfusion transmitted
disease using NAT and CLIA method on exposure to Hepatitis B virus in Red Cross
Semarang City periode April-December 2019. The result of NAT and CLIA are diviaded
to two groups, reactive or non-reactive on exposure of Hepatiti B virus. The method used
in this research is a descriptived method which is analyzed with univariat. The variabel
was obtained from medical record from Red Cross Semarang city which consist of
reactive or nonreactive in NAT and CLIA as much 6.931 population. The samples used
in this study are 100 samples, using the purposive sampling technique with predefined
criteria. In 100 samples, we found 19 reactive test with NAT methods, 17 reactive test
with NAT and CLIA and finally found 64 non reactive with NAT and CLIA. From the
population of 6.931, only 36 is reactive with NAT only, or both NAT and CLIA (19 reactive
on NAT methods and 17 reactive on NAT and CLIA methods). As the result only 0,5% is
reactive, so NAT and CLIA are important test for blood safety requirements.

Keywords:
NAT method, CLIA method, Hepatitis B

JEL: I10, I18, I19

INTRODUCTION
Hepatitis B is an infectious disease that often occurs and is caused by the Hepatitis B
virus. This virus attacks the liver, causing inflammation and causing symptoms of the disease
(Khumaedi., Gani & Hasan, 2016). Hepatitis B infection can occur prolonged/chronic or
suddenly/acute. Prolonged/chronic infection can lead to hardening/cirrhosis of the liver and
severe liver damage (Halimah & Satria, 2015); (Bustami & Anita, 2020).
According to the World Health Organization, more than 200 million people are affected
by this disease worldwide. In some areas of the world, for example Africa and Asia, infection
rates have been recorded as high as 10% of the population. This condition especially occurs
in patients who are infected at a young age. Close to 90% of patients who acquire infection
during infancy and 30-50% of patients who acquire infection before the age of 5 years will
develop chronic hepatitis B at an older age. More than 70% of patients die from symptoms and
complications of Hepatitis B infection every year (World Health Organization, 2015); (World
Health Organization, 2017).
Hepatitis B is mainly caused by the Hepatitis B virus, which is also known as HBV. This
virus can survive for 7 days outside the body, during this period, the virus can infect patients.
Transmission of the virus is through blood, which means it passes from person to person

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through exposure to infected blood or body fluids. In general, transmission is through blood
transfusions with infected blood, sharing needles or repeated use of needles that often occur
in drug users, sexual contact with someone who is infected, and spread from mother to child
(decreasing spread). If not treated, the infected mother has a 20% risk of transmitting the virus
to her baby during the delivery process. Various prevention strategies have been implemented
around the world to prevent the transmission of the virus. These include screening for blood
products during blood donation, safe injection strategies, proper disposal of used needles, and
use of barrier protection (condoms) during sexual intercourse (Plaß, et al., 2014); (Shrivastava
& Mishra, 2017).
Patients with prolonged/chronic Hepatitis B may progress to hardening/cirrhosis of the
liver, causing permanent damage and formation of connective tissue/injury to the liver
parenchyma and liver failure. Patients with cirrhosis may also have symptoms of jaundice, fluid
in the abdominal cavity (ascites) causing abdominal enlargement and taste changes. In some
patients can also develop into cancer (Sari., Windi & Mutiara, 2019).
Data Centers for Disease Control and Prevention (CDC) in 2008, the prevalence of
HBsAg in Indonesia showed a fairly high number, which was more than 8% in 2006 data
(WHO, 2015). The prevalence of hepatitis in Indonesia in 2013 was recorded at 1.2%. This
figure has doubled compared to the prevalence in 2007 which showed a figure of 0.6%
(Infodatin Ministry of Health, 2017). The Ministry of Health's Infodatin records in 2014 showed
that the five provinces with the highest prevalence of Hepatitis B in Indonesia were East Nusa
Tenggara, Papua, South Sulawesi, Central Sulawesi and North Maluku (Infodatin, 2014).
Differences in hygiene and sanitation are the cause of the high pattern of transmission, so the
prevalence of Hepatitis-B infection in Indonesia varies greatly between islands. Blood donation
data shows that areas on the island of Java have a lower prevalence of about 5% compared
to areas outside Java of 8% (Sulaiman, et al., 2010).
NAT is a screening test technology that is able to detect the presence of viral DNA/RNA
with a shorter window period, thereby significantly increasing blood safety (Shrivastava &
Mishra, 2017). This tool is very sensitive in examining even the DNA-RNA part of the blood.
“Examination using NAT can also shorten the window period of the disease. The presence of
the virus can also be detected earlier before the body's antibodies are formed (Baruah & Pal,
2019); (Pramudya, 2020).
The CLIA method is a type of biochemical test immunoassay measuring the
concentration of a substance in fluid, usually blood serum or water art by looking at the reaction
of antibodies against the antigen. HBsAg pemeriksaan test material can use serum or plasma
(Mathur, et al., 2017). The CLIA method is also used for researching HIV, HCV, HBSAG, and
Syphilis in the blood of the donor. The working principle of CLIA uses derivative of luminol with
peroxidase and H2O2 (or other enzymatic system which produce H2O2, such as oxidase
glucose or uricase) plus the addition of (derivatives of Phenol, such as p-iodophenol), which
increases light emission up to 2,800 times ((Murniasih, 2018).
Recapitulation of Hepatitis B data from the Central Java Health Office in 2018 showed
that 66 cases of Hepatitis B were found in 2014, in 2015 11 cases were found, in 2016 160
cases were found and then in 2017 & 2018 there was a decrease in Hepatitis B cases. Annual
report of results IMLTD test examination at UDD PMI Semarang City in 2018, donor blood
samples that were reactive to exposure to the Hepatitis B virus were found to be 432 donor
samples examined using the CLIA method.
This study was conducted to describe the results of the examination of infectious
infections through blood transfusion (IMLTD) using the NAT and CLIA methods on exposure
to Hepatitis B in UDD PMI Semarang City.

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RESEARCH METHOD
This research was conducted at UDD PMI Semarang City in April-December 2019. The
population in this study was 6,931 IMLTD examination results using the NAT and CLIA
methods. The samples used were 100 which were selected by purposive sampling technique.
This study is a retrospective study, which is presented descriptively. Data collection in this
study used monthly and annual reports in the IMLTD Screening Test (Transmitted Infection
Through Blood Transfusion) section in the form of the results of the IMLTD examination using
the NAT and CLIA methods for exposure to the Hepatitis B virus. Hepatitis B virus is processed
and calculated using the SPSS Statistics 23 application.

RESEARCH RESULTS AND DISCUSSION

The results of the IMLTD examination using the NAT and CLIA methods in April-
December 2019 are presented in Table 1.
Table 1. Exposure to Hepatitis B Virus on blood tests using the NAT and
CLIA methods for the period April-December 2019
Month Donation/Month NAT & CLIA NAT reactive Reactive NAT & Non Reactive
Checks CLIA
April 6761 38 0 0 38
May 5847 393 1 1 391
June 7833 223 2 0 221
July 7724 443 1 0 442
August 6945 1151 7 0 1144
September 7564 1522 1 3 1518
October 6769 1057 1 3 1053
November 6761 783 3 3 777
December 6725 1321 3 7 1311
Total 62929 6931 19 17 6895

Total donations during the April - December 2019 period were 62,929 donations, 6931
through NAT and CLIA checks. April is the month with the least samples of IMLTD examination
using the NAT method, which is 38 samples. Then in September, the month where the highest
number of donor blood samples were taken, the NAT method IMLTD examination was 1522.
The highest reactive NAT results were in August 2019, as many as 7 samples. Meanwhile, the
highest reactive NAT and CLIA samples were in December with a total of 7 samples. A total
of 6895 samples were declared non-reactive.
The lowest total donation occurred in May, amounting to 5847. Because that month is
the month of Ramadan, the month where the majority of Indonesian people fast. The highest
total donations occurred in June, which was 7724. In the month there was an increase in
donations of 2237, due to the large number of people who started donating blood again after
the month of Ramadan ended.
Table 2. Table of NAT-reactive, reactive and non-reactive NAT-CLIA
reactive sample frequencies
Frequency Percent Valid Percent Cumulative
Percent
Valid NAT reactive 19 19,0 19,0 19,0
Reactive NAT & CLIA 17 17,0 17,0 36,0
Non Reactive NAT & CLIA
64 64,0 64,0 100,0
Total 100 100,0 100,0

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Based on the data presented in Table 2, the frequency of reactive NAT samples is 19,
reactive NAT and CLIA is 17 and the frequency value for non reactive NAT and CLIA is 64.
The percentage of samples that are reactive NAT is 19%, reactive NAT and CLIA is 17% and
non reactive NAT and CLIA by 64%. The hepatitis B virus exposure diagram calculated above
is explained in Figure 1.

Figure 1. Diagram of Hepatitis B Virus Exposure on NAT and CLIA

blood tests for the period April-December 2019

The percentage of examination results from 100 samples taken showed the highest
results of 64% non-reactive samples in the NAT and CLIA methods, 19% reactive in the NAT
methods, and 17% reactive in the NAT and CLIA methods against exposure to the Hepatitis B
virus. A total of 19 donor blood samples the results of the examination are only reactive on the
NAT method, meaning that hepatitis B virus DNA is found in the blood sample. Then as many
as 17 donor blood samples whose examination results were reactive on the NAT and CLIA
methods, meaning that the hepatitis B virus DNA was found and the hepatitis B virus antigen
(HBsAg) was found in the examined donor blood samples.
One of the benefits of testing with the NAT method is that it can shorten the window
period, when HBsAg has not yet been formed and should be detected by the CLIA method.
The NAT method can detect it first by detecting the presence of Hepatitis B virus DNA in the
donor blood samples that have been examined. Thus, the examination of IMLTD with the NAT
molecular method can provide an additional layer to reduce or minimize the transmission of
infection through blood transfusions. If the blood sample is not tested for IMLTD using the NAT
method, then the 19 blood samples may transmit infection, especially the Hepatitis B virus, to
the recipient of the blood. Because in 19 donor blood samples that were reactive in the NAT
method, Hepatitis B virus DNA was detected which can only be detected using the NAT
method.
The results of the research above are in line with previous research, namely research
conducted by Mathur, A., Dontula, S., & Jagannathan, L. (2017) both found that the results of
the IMLTD examination carried out by two methods, namely the NAT method and the CLIA
method, found only reactive results in the NAT method. Another similar research result was
also conveyed by Baruah & Pal (2019), where the results of the examination showed that there
were similarities, namely reactive results only occurred in the NAT method. These results can
be used as the basis for a conclusion where the NAT method can detect hepatitis B virus
exposure earlier, namely detecting the presence of Hepatitis B virus DNA.

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The number of blood samples that will be tested for the NAT IMLTD method is very
dependent on the availability of reagents and the number of donations collected in that month.
One of the drawbacks of the NAT method is the price of reagents which is quite expensive, so
that some UDD only rely on assistance from the government. Donor blood samples examined
by the NAT method are prioritized for recipients of blood who perform multiple transfusions
such as exchange transfusion in infants, hemodialysis patients, thalassemia disease, and
pregnant women who experience postpartum hemorrhage. Therefore, the effective use of
reagents is needed to support inspection activities.
The NAT and CLIA methods of IMLTD examination are theoretically carried out at the
same time in parallel with the aim of shortening the examination time. So that blood
components whose blood samples are examined by the NAT and CLIA methods can be
immediately distributed to patients in need. The examination of the NAT method in this study
used the Procleix Panther System, while the examination of the CLIA method used the
Architect I2000SR.

CONCLUSION
Based on the research, it can be concluded that from 100 samples taken in this study,
19 test results were found that were reactive on the NAT method and non-reactive on the CLIA
method. Thus, in 19 donor blood samples, only the presence of Hepatitis B virus DNA was
detected using the NAT method of IMLTD examination. 5.1.2. Then in this study also found 17
test results that were reactive on the NAT and CLIA methods. Thus, in 17 donor blood samples,
the presence of Hepatitis B virus DNA was detected using the IMLTD examination using the
NAT method and the presence of Hepatitis B virus antigen (HBsAg) was detected using the
IMLTD examination using the CLIA method.

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