Evaluation of the diagnostic accuracy of an affordable rapid diagnostic test for African Swine Fever antigen detection in Lao People's Democratic Republic

J Virol Methods. 2020 Dec:286:113975. doi: 10.1016/j.jviromet.2020.113975. Epub 2020 Sep 18.

Abstract

African Swine Fever (ASF) is a transboundary animal disease of pigs and wild suids that appeared in Lao People's Democratic Republic (Lao PDR) in mid-2019, having spread across China and Vietnam in the months prior. Despite the scale of the Asian ASF pandemic and the availability of pen-side rapid diagnostic tests (RDT) on the market, few locally produced and easily available ASF RDTs have been evaluated for diagnostic accuracy. In this study, an ASF antigen detection RDT from Shenzhen Lvshiyuan Biotechnology Co. Ltd was evaluated using clinical field samples submitted to the National Animal Health Laboratory (NAHL) from ASF suspect cases between June and December 2019 in Lao PDR. Positive (n = 57) and negative (n = 50) samples of whole blood, serum and haemolysed serum were assessed by RDT and PCR, with the latter used as the gold standard reference comparator. Overall the RDT had a diagnostic sensitivity (DSe) of 65 %, 95 % CI [51-77] and diagnostic specificity (DSp) of 76 %, 95 % CI [62-87]. The RDT demonstrated improved performance on samples with lower PCR cycle threshold (ct) values with each additional cycle reducing the odds of the RDT returning a positive by 17 % relative to the previous cycle, 95 % CI [8 %-28 %] (P < 0.01). While this test shows promise for field application, complete validation of diagnostic accuracy requires a larger sample size.

Keywords: African Swine Fever; Diagnostic accuracy; Lao PDR; Polymerase chain reaction; Rapid diagnostic test.

Publication types

  • Research Support, Non-U.S. Gov't
  • Research Support, U.S. Gov't, Non-P.H.S.

MeSH terms

  • African Swine Fever* / diagnosis
  • Animals
  • Diagnostic Tests, Routine
  • Immunologic Tests
  • Laos
  • Polymerase Chain Reaction
  • Swine