Review Article

iMedPub Journals 2022

Health Science Journal
www.imedpub.com Vol. 16 No. 8: 963
ISSN 1791-809X
DOI: 10.36648/1791-809X.16.8.963

Diagnostic Effectiveness of All Test HBsAg Rapid Zhang Lei1, Yang Feng2, Zhu
Test Kit Compared with ELISA Serology Junzhe
3

1 Zhejiang Gongshang University

2 Community Health Service Center, Yipeng
Abstract Street, Qiantang District, Hangzhou
Background: HBsAg Rapid Diagnostic Tests (RDT) has been developed for the detection 3 Wenzhou Medical University
of hepatitis B surface antigen (HBsAg). They represent a promising alternative to
enzyme immunoassays and a powerful tool for large-scale screening and diagnosis of
HBV infection, especially in regions without access to serological and molecular testing *Corresponding author:
(3). Zhang Lei

Objective: This study aimed to evaluate the effectiveness of the AllTest HBsAg Rapid
Test Kits for the qualitative detection of Hepatitis B Surface Antigen (HBsAg) in whole
 [email protected]
blood, serum or plasma to aid in the diagnosis of hepatitis B virus (HBV) infection.
Zhejiang Gongshang University China
Method: A rapid in vitro diagnostic test device for detection of HBsAg in Whole Blood,
Serum or Plasma was evaluated and compared with ELISA serology. Sensitivity (Se) and
specificity (Sp) were used to estimate test performance. Citation: Lei Z, Feng Y, Junzhe Z (2022)
Results: The relative Se and Sp (lower bound of 95% CI) were as follows: >99.9% Diagnostic Effectiveness of All Test HBsAg
and 99.6% for serum or plasma specimens; and >99.9% and 99.5% for whole blood Rapid Test Kit Compared with ELISA
specimens. Serology. Health Sci J. Vol. 16 No. 8: 963.
Conclusion: The All Test HBsAg Rapid Test Kit could be considered an ideal method
for HBV screening, given the ease of use, fast testing time, and high accuracy. The test
utilizes a combination of monoclonal and polyclonal antibodies to selectively detect
elevated levels of HBsAg in whole blood, serum or plasma.
Keywords: Antenatal care; Ethiopia; Gondar city; Perceived Stress

Received: 01-Jun-2022, Manuscript No. iphsj-22-12835; Editor assigned: 03-Jun-2022, Pre-qc

No. iphsj-22-12835; Reviewed: 25-Jul-2022, QC No. iphsj-22-12835; Revised: 30-Jul-2022,
Manuscript No. iphsj-22-12835 (R); Published: 08-Aug-2022, DOI: 10.36648/1791-809X.16.8.963

Introduction 2 to 4 weeks before the ALT level becomes abnormal and 3 to

5 weeks before symptoms or jaundice develop. HBsAg has four
Hepatitis B virus (HBV), a DNA virus with a human-only reservoir, principal subtypes: adw, ayw, adr and Ayr. Because of antigenic
is a worldwide public health issue [5]. In Far-East Asia and tropical heterogeneity of the determinant, there are 10 major serotypes
Africa, chronic carriers of the HBV represent 10% or more of the of the HBV.
population and chronic active hepatitis and liver cirrhosis are
major causes of mortality (6). Moreover, epidemiological studies HBV Prevention
have clearly shown the importance of HBV in hepatocellular
More than two billion people have been infected worldwide, and
carcinoma (HCC), one of the most common cancers in the world
of these, more than 350 million suffer from chronic HBV infection
[1, 7]. In China, between 500,000 and one million new cases
[7]. The incidence of HBV infection and patterns of transmission
appear every year. HBV is one of the few viruses known to be
vary greatly throughout the world in different population
involved in human cancer [1, 8]. Viral hepatitis is a systemic
subgroups [7]. In Western countries, chronic HBV infection is
disease primarily involving the liver. Most cases of acute viral
relatively rare and acquired primarily in adulthood, whereas
hepatitis are caused by hepatitis A virus, hepatitis B virus or
in Asia and most of Africa, most infections occur from infected
hepatitis C virus. The complex antigen found on the surface of
mother to child, from child-to-child contact in household settings,
HBV is called HBsAg. Previous designations included Australia or
and from the reuse of unsterilized needles and syringes.
Au antigen [2]. The presence of HBsAg in whole blood, serum or
plasma is an indication of an active HBV infection, either acute or Due to the often silent nature of the disease, testing for HBV is
chronic. In a typical hepatitis B infection, HBsAg will be detected imperative for public health, particularly for blood screening.

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 Health Science Journal
2022
Vol. 16 No. 8: 963
ISSN 1791-809X

Chronic carriers with undetected acute infection and low levels For Venipuncture Whole Blood specimen
of viremia are vulnerable to HBV transmission [3]. Studies also
show that early diagnosis and treatment can reduce the risk of Three drops of whole blood (approximately 75 μl) are added
the development of long-term complications and prevent further to the specimen area and then one drop of buffer solution
transmission [4]. The World Health Organization (WHO) aims to (approximately 40 μl).
contribute to the global prevention and control of viral hepatitis For Finger stick Whole Blood specimen
infections by [5-7]
Fill the capillary tube and transfer approximately 75 μl of finger
• Recommending that hepatitis B vaccine be included in routine stick whole blood specimen to the specimen area and then one
immunization services in all countries. The goal for the future drop of buffer solution (approximately 40 μl). The intensity of
is the establishment of national immunization programs for the color in the Test line region (T) will vary depending on the
hepatitis B in all countries where such are not yet in place or are concentration of HBsAg present in the specimen. Therefore, any
not completely implemented. The Global Alliance for Vaccines shade of color in the Test line region (T) should be considered a
and Immunization (GAVI) created in 1999 is a unique coalition of positive result. A colored line will always appear at the Control
public and private institutions that provide support for the 74 low- (C) location on the cassette to indicate that the assay worked
income countries to reinforce their national vaccine programs correctly. The test result is obtained in 30 minutes or less.
and introduce hepatitis B, yellow fever, and Hemophilic influenza
type b vaccines into their national immunization programs. As of The AllTest HBsAg Rapid Test Kit correctly identified specimens
now, a total of 147 countries have implemented mass vaccination of a seroconversion panel and was compared to ELISA, which
of newborns and infants [8]. served as the gold standard. The results show that the relative
sensitivity of the HBsAg Rapid Test Kit to plasma and serum
• Promoting safe injection techniques that are essential for specimens is >99.9% and the relative specificity is 99.6%. The
reducing the global HBV-related morbidity and mortality. relative sensitivity of the HBsAg Rapid Test Kit to whole blood
• Raising the awareness of HBV infection among health care specimens is >99.9% and the relative specificity is 99.5%.
providers, policymakers, and the public. (See Table 1 &2: AllTest HBsAg Rapid Test Compared to ELISA
HBsAg Test Kit) Within-run precision was determined by using
• Collaboration with patient support groups to improve health 10 replicates of six specimens containing 0ng/ml, 1ng/ml, 2ng/
education, prevention efforts, and treatment compliance. ml, 5ng/ml, 12ng/ml, and 20ng/ml of HBsAg. The negative and
• Stressing the potential impact of preventive strategies. positive values were correctly identified >99% of the time.
Between-run precision was determined by using the same six
HBsAg Rapid Test Kit Materials and Method specimens of 0ng/ml, 1ng/ml, 2ng/ml, 5ng/ml, 12ng/ml, and
The AllTest HBsAg Rapid Test Kit (Whole Blood/Serum/Plasma) 20ng/ml of HBsAg in 3 independent assays. Three different lots
is a new rapid immunochromatographic test for the qualitative of the HBsAg Rapid Test Cassette (Whole Blood/Serum/Plasma)
detection of HBsAg that is performed manually. The single test have been tested using negative, low positive and high positive
specimens. The specimens were correctly identified >99% of the
kit consists of a test cassette, a dropper, a buffer and a package
time (Tables 1 and 2).
insert. The membrane is pre-coated with anti-HBsAg antibodies
on the test line region of the cassette. During testing, the whole Table 1. All Test HBsAg Rapid Test Compared to ELISA HBsAg Test Kit
blood, serum or plasma specimen reacts with the particle coated Serum or plasma specimens.
with anti-HBsAg antibodies. The mixture migrates upward on the
Method   ELISA   Total Results
membrane chromatographically by capillary action to react with
HBsAg Rapid Test Results Positive Negative
anti-HBsAg antibodies on the membrane and generate a colored (WB/Serum/Plasma) Positive 180 2 182
line. The presence of this colored line in the test region indicates
Negative 0 550 550
a positive result, while the absence of the colored line indicates
Total Results 180 552 732
a negative result. To serve as a procedural control, a colored
Relative Sensitivity: ＞99.9% (95%CI: *98.3%-100%)
line will always appear in the control line region indicating that
Relative Specificity: 99.6% (95%CI: *98.7%-99.9%)
the proper volume of specimen has been added and membrane Overall accuracy: 99.7% (95%CI: *99.0%-99.9%)
wicking has occurred.
Table 2. AllTest HBsAg Rapid Test Compared to ELISA HBsAg Test Kit
The HBsAg Rapid Test Kits can be performed using whole blood
Whole Blood specimens.
(from venipuncture or finger stick), serum or plasma. The three
specific operation methods are as follows: Method   ELISA   Total Results
HBsAg Rapid Test Results Positive Negative  
For Serum or Plasma specimen (WB/Serum/Plasma) Positive 180 1 181
The first step is to separate serum or plasma as soon as possible Negative 0 200 200
to avoid hemolysis. The instructions note to only use clear non- Total Results   180 201 381
hemolysis specimens. Next, three drops of serum or plasma Relative Sensitivity: ＞99.9% (95%CI: *98.3%-100%)
(approximately 75 μl) are added to the specimen area and start Relative Specificity: 99.5% (95%CI: *97.3%-99.9%)
the timer. Overall accuracy: 99.7% (95%CI: *98.5%-99.9%)

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 Health Science Journal
2022
Vol. 16 No. 8: 963
ISSN 1791-809X

Compared to conventional testing methods, rapid tests can easy-to-run and highly sensitive assay that can be used in both
be performed directly at the point-of-care (POC) and produce high- and low-risk populations for the diagnosis of HBsAg carriage
results in 15-30 minutes, enabling healthcare providers to quickly with 99.7% accuracy. As many studies indicate, rapid diagnostic
share results with patients. Therefore, in the last 20 years, the tests appear as promising new tools for large-scale screening and
availability and use of POC tests have markedly increased and diagnosis of HBV infection in clinical settings [3]. However, the
expanded to all fields of medicine. In the setting of infectious laboratory evaluation could differ from test performance outside
diseases, most existing POC tests consist of immunoassays, of a laboratory due to factors such as limited sample size and
including agglutination or immunochromatographic strips (strip staff training. From the results of the tested samples, it presents
tests). These methods can be used to accurately detect HBsAg. that the HBsAg Rapid Test Kit developed by Hangzhou AllTest
Biotech Co., Ltd meets the requirements of intended use.
Summary
In conclusion, the AllTest HBsAg Rapid Test kit is a simple, fast,

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