Evaluation of immunoassays for the diagnosis of Schistosoma japonicum infection using archived sera.
BACKGROUND
With a national program initiated recently to reduce transmission of Schistosoma japonicum in the People's Republic of China (P.R. China), there is an urgent need for accessible, quality-assured diagnostics for case detection, surveillance, and program monitoring of chemotherapy efficacy and other control interventions in areas of low endemicity. We compared the performance of nine immunodiagnostic tests developed in P.R. China for detection of antibodies against S. japonicum and established their priority for further assessment in field settings.


RESULTS
Using the Kato-Katz technique as the reference standard, 240 well-characterized archived serum specimens (100 positive and 140 negative) were evaluated in nine immunological tests developed in P.R. China. The enzyme-linked immunoelectrotransfer blot assay (EITB), which uses an adult worm extract of S. japonicum, supplied by the Center of Disease Control and Prevention, USA, was also evaluated. The sensitivity and specificity of each test were determined and the reproducibility of each test was assessed by evaluating operator-to-operator and run-to-run variation. In addition the simplicity of use for the end-user was evaluated. All tests showed good sensitivities ranging from 92.0% (95% confidence interval (CI): 86.7-97.3%) to 98.0% (95% CI: 95.3-100.0%). The test specificities varied from 70.0% (95% CI: 62.4-77.6%) to 97.1% (95% CI: 94.4-99.9%). All tests showed excellent reproducibility with a discordant rate in the range of 0-10.0% for operator-to-operator variation and run-to-run variation. All tests, except one magnetic particle-based enzyme-linked immunosorbent assay, were found to be easy to use, especially the dot immunogold filtration assays.


CONCLUSIONS
Most evaluated tests had acceptable performance characteristics and could make an impact on the schistosomiasis control programs in P.R. China. Three tests with the highest sensitivity, specificity and greatest ease of use, were selected for further evaluation in field settings.
National Institute of Parasitic Diseases, Chinese Center for Disease Control and Prevention, Shanghai, People's Republic of China.
Jing
J
Xu
Rosanna W
RW
Peeling
Jia-Xu
JX
Chen
Xiao-Hua
XH
Wu
Zhong-Dao
ZD
Wu
Shi-Ping
SP
Wang
Ting
T
Feng
Shao-Hong
SH
Chen
Hao
H
Li
Jia-Gang
JG
Guo
Xiao-Nong
XN
Zhou
D000818:Animals; D000909:Antibodies, Helminth / Q000097:blood*; D000947:Antigens, Helminth; D002681:China; D006801:Humans; D007118:Immunoassay / Q000379:methods; D010274:Parasitology / Q000379:methods*; D015203:Reproducibility of Results; D012549:Schistosoma japonicum / Q000276:immunology*; D012554:Schistosomiasis japonica / Q000175:diagnosis*; D012680:Sensitivity and Specificity
D000909:Antibodies, Helminth; D000947:Antigens, Helminth
Int J Parasitol. 2006 Jul;36(8):895-902
16759658
Trends Parasitol. 2009 Apr;25(4):151-6
19269899
Trends Parasitol. 2004 Jan;20(1):35-9
14700588
Nat Rev Microbiol. 2004 Mar;2(3):231-40
15083158
Acta Trop. 2005 Nov-Dec;96(2-3):130-6
16143288
Trop Med Int Health. 2009 Dec;14(12):1475-83
19793080
Acta Trop. 2005 Nov-Dec;96(2-3):97-105
16125655
Zhongguo Ji Sheng Chong Xue Yu Ji Sheng Chong Bing Za Zhi. 2009 Jun;27(3):223-6
19852363
Exp Parasitol. 2009 Feb;121(2):175-9
19027005
Southeast Asian J Trop Med Public Health. 2006 Mar;37(2):257-64
17124983
Adv Parasitol. 2010;73:171-95
20627143
J Immunol. 1983 Mar;130(3):1366-70
6185578
Zhonghua Liu Xing Bing Xue Za Zhi. 2004 Jul;25(7):555-8
15308031
Adv Parasitol. 2010;72:145-78
20624531
Acta Trop. 2008 Aug;107(2):128-33
18589392
Lancet. 2008 Nov 22;372(9652):1793-5
18930529
Bull World Health Organ. 1987;65(2):233-44
3111737
Emerg Infect Dis. 2007 Oct;13(10):1470-6
18257989
Am J Trop Med Hyg. 2007 Jun;76(6):1138-43
17556625
Rev Inst Med Trop Sao Paulo. 1972 Nov-Dec;14(6):397-400
4675644
Am J Trop Med Hyg. 1998 Sep;59(3):370-5
9749627
Bull World Health Organ. 1982;60(5):729-53
6983926
Zhongguo Ji Sheng Chong Xue Yu Ji Sheng Chong Bing Za Zhi. 2000;18(2):92-3
12567723
Nat Rev Microbiol. 2006 Dec;4(12 Suppl):S20-32
17366684
Chin Med J (Engl). 1996 Sep;109(9):659-64
9275331
Adv Parasitol. 2010;72:1-30
20624526
Acta Trop. 2005 Nov-Dec;96(2-3):142-7
16207482
Zhonghua Yu Fang Yi Xue Za Zhi. 2006 Jul;40(4):244-7
17097002
Acta Trop. 2005 Nov-Dec;96(2-3):69-96
16312039
Int J Parasitol. 2010 Mar 1;40(3):327-31
19735662
Lancet Infect Dis. 2006 Jul;6(7):411-25
16790382
Parasitol Int. 2008 Sep;57(3):281-6
18485807
Acta Trop. 2008 Jan;105(1):74-80
18036505
Immunol Invest. 1997 Jan-Feb;26(1-2):175-88
9037622
N Engl J Med. 2009 Jan 8;360(2):121-8
19129526
Acta Trop. 2002 May;82(2):193-8
12020892
Parasitology. 2002 Sep;125(Pt 3):221-31
12358419