Rapid Diagnostic Test for Hepatitis B Virus Viral Load Based on Recombinase Polymerase Amplification Combined with a Lateral Flow Read-Out.
Diagnostics (Basel)
; 12(3)2022 Mar 02.
Article
in English
| MEDLINE | ID: covidwho-1760429
ABSTRACT
Hepatitis B (HBV) infection is a major public health concern. Perinatal transmission of HBV from mother to child represents the main mode of transmission. Despite the existence of effective immunoprophylaxis, the preventive strategy is inefficient in neonates born to mothers with HBV viral loads above 2 × 105 IU/mL. To prevent mother-to-child transmission, it is important to identify highly viremic pregnant women and initiate antiviral therapy to decrease their viral load. We developed a simple innovative molecular approach avoiding the use of automatic devices to screen highly viremic pregnant women. This method includes rapid DNA extraction coupled with an isothermal recombinase polymerase amplification (RPA) combined with direct visual detection on a lateral flow assay (LFA). We applied our RPA-LFA approach to HBV DNA-positive plasma samples with various loads and genotypes. We designed a triage test by adapting the analytical sensitivity to the recommended therapeutic decision threshold of 2 × 105 IU/mL. The sensitivity and specificity were 98.6% (95% CI 92.7-99.9%) and 88.2% (95% CI 73.4-95.3%), respectively. This assay performed excellently, with an area under the ROC curve value of 0.99 (95% CI 0.99-1.00, p < 0.001). This simple method will open new perspectives in the development of point-of-care testing to prevent HBV perinatal transmission.
Full text:
Available
Collection:
International databases
Database:
MEDLINE
Type of study:
Diagnostic study
Language:
English
Year:
2022
Document Type:
Article
Affiliation country:
Diagnostics12030621
Similar
MEDLINE
...
LILACS
LIS