False-Negative Hepatitis B Virus (HBV) Surface Antigen in a Vaccinated Dialysis Patient with a High Level of HBV DNA in the United States

Abstract

Screening with hepatitis B surface antigen (HBsAg) is highly recommended for at-risk individuals. Mutations in the HBsAg can result in an inability to detect the virus during routine screening. We describe a hemodialysis patient found to have high levels of hepatitis B virus (HBV) DNA and HBV antibody but negative HBsAg on two routine assays.

Hepatitis B Virus Mutant Infections in Hemodialysis Patients: A Case Series

“…These cases demonstrate the varying ability of different HBsAg assays to detect mutant HBV strains, as has been previously described, [11][12][13][14][15]19 and highlight the potential public health risk to hemodialysis patients. 13,15 In some instances, patients who had had active HBV infection diagnosed had subsequent false-negative HBsAg test results (eg, at a different health care facility), which led to delays in applying appropriate infection control measures. 13,15 Considerations for monitoring of HBV-susceptible dialysis patients are summarized in Figure 1.…”

“…13,15 In some instances, patients who had had active HBV infection diagnosed had subsequent false-negative HBsAg test results (eg, at a different health care facility), which led to delays in applying appropriate infection control measures. 13,15 Considerations for monitoring of HBV-susceptible dialysis patients are summarized in Figure 1. Clinicians should be aware that in some instances it is possible for a patient to have HBV infection in the absence of detectable HBsAg.…”

“…Of note, while the ETI-MAK-2 PLUS enzyme-linked immunosorbent assay detected a strain with sG145R mutation in 2017, 15 it failed to detect a strain with multiple mutations in a 2010 investigation. 13 It is important that dialysis providers report HBV seroconversions and suspected mutant HBV infections to the appropriate public health authority.…”

Reactivation of a Vaccine Escape Hepatitis B Virus Mutant in a Cambodian Patient During Anti-Hepatitis C Virus Therapy

“…Prior studies in China and France have noted between 3.4 ( 26 ), 4.9 ( 27 ), and 8.9% ( 14 ) of HBV-infected patients to have coexistent HBsAg and anti-HBs. Anti-HBs escape mutations have been described in the USA in infants born to HBV-infected mothers following postnatal HBV vaccine and hepatitis B immune globulin (HBIG) prophylaxis and in many liver-transplant recipients who develop HBV re-infection despite HBIG prophylaxis ( 28 – 30 ) as well as one HBV vaccinated patient post lung transplant on hemodialysis ( 31 ). To the best of our knowledge, this is the first report of a mutation in the “a”-determinant region (G145A) in a patient in the USA with chronic HBV infection in the absence of receiving HBV vaccine or HBIG ( 28 , 31 , 32 ).…”

Donor screening for hepatitis B: hepatitis B surface antigen—a belt, suspenders, and another belt?

“…Pathogen evolution can allow false‐negative assay results, due to genome sequence changes that affect NAT, or to epitope changes that alter the performance of serologic tests . Current donor molecular screening assays, while relevant details are proprietary, can reduce this risk using several strategies.…”