Diagnostic accuracy of serological kits for Helicobacter pylori infection with the same assay system but different antigens in a Japanese patient population
Helicobacter pylori infection is thought to be a causal risk factor for gastric carcinoma. Recently, diagnostic accuracy of serological kits for H. pylori infection that were made in Western countries has been reported to be lower when used among Oriental populations. Diagnostic accuracy of two serological kits [HM-CAP and HM-CAP with antigens extracted from clinically isolated Japanese H. pylori strains (J-HM-CAP)] was investigated in 440 samples from a Japanese patient population by using the 13C-urea breath test as gold standard. According to the original optimal cut-off value, HM-CAP provided 87.5 % sensitivity and 84.8 % specificity with 86.8 % accuracy and J-HM-CAP provided 95.5 % sensitivity and 81.9 % specificity with 92.3 % accuracy. This study suggests that antigens from HM-CAP are satisfactory for examining a Japanese patient population, but that using local antigens improves accuracy.
CrabtreeJ. E,
ShallcrossT. M,
HeatleyR. V,
WyattJ. I.1991; Evaluation of a commercial ELISA for serodiagnosis of Helicobacter pylori infection. J Clin Pathol 44:326–328[CrossRef]
EvansD. JJr,
EvansD. G,
GrahamD. Y,
KleinP. D.1989; A sensitive and specific serologic test for detection of Campylobacter pylori infection. Gastroenterology 96:1004–1008
GrahamD. Y,
EvansD. J,
PeacockJ.Jr,
BakerJ. T,
SchrierW. H.1996; Comparison of rapid serological tests (FlexSure HP and QuickVue) with conventional ELISA for detection of Helicobacter pylori infection. Am J Gastroenterol 91:942–948
JensenA. K. V,
AndersenL. P,
GaarslevK,
WachmannC. H.1993; Comparison of four second generation kits for detection of IgG antibodies against Helicobacter pylori in adults. Zentbl Bakteriol 280:221–226[CrossRef]
KhannaB,
CutlerA,
IsraelN. R,
PerryM,
LastovicaA,
FieldsP. I,
GoldB. D.1998; Use caution with serologic testing for Helicobacter pylori infection in children. J Infect Dis 178:460–465[CrossRef]
LeungW. K,
NgE. K. W,
ChanF. K. L,
ChungS. C. S,
SungJ. J. Y.1999; Evaluation of three commercial enzyme-linked immunosorbent assay kits for diagnosis of Helicobacter pylori in Chinese patients. Diagn Microbiol Infect Dis 34:13–17[CrossRef]
MarchildonP. A,
CiotaL. M,
ZamaniyanF. Z,
PeacockJ. S,
GrahamD. Y.1996; Evaluation of three commercial enzyme immunoassays compared with the 13C urea breath test for detection of Helicobacter pylori infection. J Clin Microbiol 34:1147–1152
MarchildonP. A,
SugiyamaT,
FukadaY,
PeacockJ. S,
AsakaM,
ShimoyamaT,
GrahamD. Y.2003; Evaluation of the effects of strain-specific antigen variation on the accuracy of serologic diagnosis of Helicobacter pylori infection. J Clin Microbiol 41:1480–1485[CrossRef]
MeijerB. C,
ThijsJ. C,
KleibeukerJ. H,
van ZwetA. A,
BerrelkampR. J. P.1997; Evaluation of eight enzyme immunoassays for detection of immunogloblin G against Helicobacter pylori . J Clin Microbiol 35:292–294
MiwaH,
MuraiT,
OhkuraR,
KawabeM,
TanakaH,
OgiharaT,
WatanabeS,
SatoN.1997; Effect of fasting subjects’ posture on 13C-urea breath test for detection of Helicobacter pylori infection. Helicobacter 2:82–85[CrossRef]
MiwaH,
MuraiT,
OhkuraR,
NagaharaA,
WatanabeH,
TeraiT,
WatanabeS,
SatoN.1998; Usefulness of the [13C]-urea breath test for detection of Helicobacter pylori infection in fasting patients. J Gastroenterol Hepatol 13:1039–1043[CrossRef]
NomuraA,
StemmermannG. N,
ChyouP. H,
KatoI,
Perez-PerezG. I,
BlaserM. J.1991; Helicobacter pylori infection and gastric carcinoma among Japanese Americans in Hawaii. N Engl J Med 325:1132–1136[CrossRef]
OhtsukaY,
ShimadaT,
WatanabeN,
AkiyamaH,
SuzukiY,
IshidaM,
HiraishiH,
TeranoA.1997; Analysis of the vacA gene sequences among Helicobacter pylori strains isolated from Japanese patients. Gastroenterology 112:A243abstract
RaymondJ,
SauvestreC,
KalachN,
de KorwinJ. D,
ValverdeV.1999; Evaluation of a new serologic test for diagnosis of Helicobacter pylori infection in children. Eur J Clin Microbiol Infect Dis 18:192–198[CrossRef]
WilcoxM. H,
DentT. H. S,
HunterJ. O,
GrayJ. J,
BrownD. F. J,
WightD. G. D,
WraightE. P.1996; Accuracy of serology for the diagnosis of Helicobacter pylori infection – a comparison of eight kits. J Clin Pathol 49:373–376[CrossRef]
Diagnostic accuracy of serological kits for Helicobacter pylori infection with the same assay system but different antigens in a Japanese patient population