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Discrepancy between anti-hepatitis E virus immunoglobulin G prevalence assessed by two assays in kidney and liver transplant recipients

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Abstract

Background

Hepatitis E virus (HEV) is an emerging clinical threat in Europe among kidney and liver-transplant recipients. The incidence and prevalence of HEV infection in this special population are poorly known. False-negative results have been observed for anti-HEV IgG detection in severely immunocompromized persons. Moreover, large discrepancies have been reported between rates of anti-HEV IgG detection in blood donors and hepatitis E cases.

Objectives

To compare anti-HEV IgG and IgM prevalence using two different commercial microplate enzyme-immuno assays (MEIAs) (Adaltis and Wantai) in 64 kidney-/liver-transplant recipients.

Study design

Serum samples tested in our routine clinical practice over the 12/2009–12/2011 period with Adaltis MEIAs were retrospectively tested using Wantai MEIAs. IgG-positive sera were further tested by an immunoblot while those found IgM-positive were further tested with an immunochromatography rapid test and for the presence of HEV RNA.

Results

Positive results on anti-HEV IgG testing were obtained for seven (10.9%) compared to 20 (31.3%) serum samples with Adaltis and Wantai assays, respectively (p = 0.005). Then, 6/7 (86%) of the serum samples positive with Adaltis and 16/20 (80%) of those positive with Wantai were positive with the immunoblot. One patient with chronic HEV infection was IgG-negative with both MEIAs. Regarding anti-HEV IgM, Adaltis and Wantai assays were concordant for 97% of the serum samples, prevalence being 8% with both MEIAs.

Conclusions

The accuracy of currently available commercial or in-house anti-HEV IgG MEIAs should be tested comparatively on a panel of serum samples collected from solid organ-transplant recipients, including some who experienced PCR-documented HEV infection.

Section snippets

Background

Hepatitis E virus (HEV) is an emerging clinical threat in Europe among kidney and liver-transplant recipients. Thus, >50% of infections turn chronic and subsequent rapid cirrhosis has been described.1, 2 Incidence and prevalence of HEV infection in this special population are poorly known. The rate of previous exposure has been tentatively assessed through anti-HEV IgG testing and was ≈4%.3, 4 However, a long-lasting considerable distrust exists regarding anti-HEV microplate enzyme-immuno

Objectives

We compared anti-HEV IgG and IgM prevalence using two different commercial MEIAs including Wantai assays in 64 solid organ transplant recipients.

Study design

Patients studied were 50 kidney-transplant, 12 liver-transplant, and 2 kidney- and liver-transplant recipients for whom serum collected over the 12/2009–12/2011 period has been tested for anti-HEV IgG and IgM in our routine clinical practice with Adaltis MEIAs (EIAgen, Adaltis, Casalecchio Di Reno, Italy). These serum samples were retrospectively tested using Wantai MEIAs (Wantai Biologic Pharmacy Enterprise, Beijing, People's Republic of China). Tests were performed according to manufacturers’

Results

Comparative analysis of anti-HEV IgG results on the 64 serum samples showed 7 positive results (10.9%) and one ‘gray zone’ result with Adaltis MEIA versus 20 positive results (31.3%) and three ‘gray zone’ results with Wantai assay (p = 0.005; Table 1). Thus, prevalence was 2.9 times higher when assessed by Wantai compared to Adaltis. The two assays were concordant for only 77% (49/64) of serum samples. Regarding positive results, mean SCR was 5.5 ± 4.7 (range, 1.2–10.6) with Adaltis assay and 8.2 ± 

Discussion

Reliable assessment of HEV exposure is influential in improving our knowledge on HEV epidemiology, identifying sources and routes of HEV transmission, studying duration of protection post-HEV exposure, or diagnosing HEV reactivation. This is particularly important among kidney-/liver-transplant recipients in whom HEV infection is a considerable clinical concern.1, 2, 13 Present findings indicate that anti-HEV IgG prevalence is high in kidney/liver-transplant recipients in our geographical area

Funding

None for all authors.

Competing interest

None for all authors.

Ethical approval

None required.

Acknowledgement

None.

References (20)

There are more references available in the full text version of this article.

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