Abstract
Detection of hepatitis B Virus surface antigen (HBsAg) is an established method for diagnosing both acute and chronic hepatitis B virus (HBV) infection. In addition to enzyme immunoassays (EIAs), rapid diagnostic tests (RDTs) are available for the detection of HBsAg in resource-poor settings. However, the available RDTs have inadequate sensitivity and therefore are not suitable for diagnosis of patients with low levels of HBsAg and for blood screening. To provide a high-sensitivity RDT, we developed a lateral flow immunoassay (LFIA) for HBsAg utilizing upconverting nanoparticle (UCNP) reporter. The UCNP-LFIA can use whole blood, serum, or plasma and the results can be read in 30 min using a reader device. When compared with a commercial conventional visually read LFIA, the developed UCNP-LFIA had a Limit of Detection (LoD) of 0.1 IU HBsAg/ml in spiked serum, whereas the LoD of the conventional LFIA was 3.2 IU HBsAg/ml. The developed UCNP-LFIA fulfills the WHO criterion for blood screening (LoD ≤ 0.13 IU HBsAg/ml) in terms of LoD. The UCNP-LFIA and conventional LFIA were evaluated with well-characterized sample panels. The UCNP-LFIA detected 20/24 HBsAg-positive samples within the HBsAg Performance Panel and 8/10 samples within the Mixed Titer Performance Panel, whereas the conventional LFIA detected 8/24 and 4/10 samples in these panels, respectively. The performance of the assays was further evaluated with HBsAg-positive (n = 108) and HBsAg-negative (n = 315) patient samples. In comparison with a central laboratory test, UCNP-LFIA showed 95.4% (95% CI: 89.5–98.5%) sensitivity whereas sensitivity of the conventional LFIA was 87.7% (95%CI: 79.9–93.3%).
Highlights
Hepatitis B virus (HBV) can be transmitted through contact with infected blood or other body fluids as well as perinatally from infected mothers to neonates
HBV can cause chronic liver infection which may result in cirrhosis and hepatocellular carcinoma leading to death [4]
The following commercial sample panels were purchased from SeraCare Life Sciences Inc. (MA, USA): AccuSetTM hepatitis B Virus surface antigen (HBsAg) Performance Panel (0805-0340), AccuSetTM HBsAg Mixed Titer Performance Panel PHA207(M) (0805-0217), AccuSetTM HBV Worldwide Performance Panel (08050313), HBV Seroconversion Panel PHM941 (0606-0060) and 24 HBsAg-positive disease-state samples
Summary
Hepatitis B virus (HBV) can be transmitted through contact with infected blood or other body fluids as well as perinatally from infected mothers to neonates. HBV is a major health problem in low- and middle-income countries (LMIC) [3]. Over 67% of chronically infected carriers of HBV are living in Asia and Africa. Prevalence is highest in the African (6.1%) and Western Pacific regions (6.2%) [1]. Many countries in these regions have HBV prevalence higher than 10%. Most of the infected individuals are asymptomatic at the early stage of infection. HBV can cause chronic liver infection which may result in cirrhosis and hepatocellular carcinoma leading to death [4]
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