Evaluation of the Accuracy of Diagnostic Tests for ... · Evaluation of the Accuracy of Diagnostic...

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Evaluation of the Accuracy of Diagnostic Tests for Helicobacter Pylori Infection Hirokatsu N>H=>BJG6, Mitsuru S:D, Mitsuo O@696, Motonobu K6C96, Motoko K6L6H=>B6 and Kazuo T6BJG6 Department of The First Internal Medicine, School of Medicine, Fukuoka University Abstract : The aim of this study was to evaluate the accuracy of five diagnostic tests for H. pylori. Each gastric specimen underwent PCR, culture and histological exam- inations. Serology and +- CUBT analyses were also performed before or after en- doscopy. The sensitivity and specificity were as follows ; for PCR : 3240and +**, for culture : 3*4-and +**, for the histological examination : 204+and +**, for +- CUBT : 3-4+and 3/42, and for serology : 3240and 114+. These results sug- gest that a combination of the above diagnostic tests would likely improve the accuracy of detecting H. pylori infection. Key words : Helicobacter pylori, diagnostic test, PCR, +- CUBT Helicobacter pylori 腇腏腁腒腀腃腍腓腂腘腄 ῍῍PCR 腖腛腚腙腜腐腌腆腔腉腋+- CUBT腈腎腊腑腚腂腗腅腉腕῍῍ 膱膹 膎膿 膭臑 腸臇 膍臁 膪臇 膃膩 膳臉 膶膗 臇膹 臤臕 臗腸膽腽腶腽臖 膾腷臍腺 腎腉 H. pylori 腠膼腕腩 / 膟臡腡膊膔臚 PCR 臏臞臚臓臟膷膨腽臅膊膔+- CUBT膉膮膏膻臚腡膰臈腠腜腌腝臐腼膊臋腔腚+,*臛腡腾膞腠膥臖膣腹膁臍膚膅腬膙膑腔PCR 臏臞臚臓臟膷膨腽臅膊膔腡腚腥腵膵臄臖膽臥腎腧腣膻臂臖膽臥腏腨腻- 膋腖腜膯膊腔 膥臖膣腹膁臍膚膅腡膵腦腔腑腢膌腠 +- CUBT 腎腧腣膉膮膏膻臚腡腚腥腡膖膉腬膑腛腚腻膊膔腡膀臈臌腴臈腢腘腪腙腪PCR 3240+**腉腁 臏臞臚 3*4-+**腉腁 臓臟膷膨 腽臅膊膔 204++**腉腁 +- CUBT 3-4+3/42腉腁 膉膮膏膻臚 3240114+腞腋腛 H. pylori 膡膆膛臠膌腡膤臢腬膡腌腝臘膲腔腚膧膒膉膮膏膻臚腡臌腴臈腢224+腠膥膢腔 膉膮膏膻臚腢膡膆膌腡膤臢腬膂腥腩腟臌腴臈腐膕腦臃腑膡膆膌腡 H. pylori 腡膫臀腠腎 腌腝腢臔臆臊腞腋腩腟膐腍腨腪腚膡膆膛臠腬臜臅腟腔腚 H. pylori 膀膴腡膫臀腠腢臏臞臚腐 臒膬腞腋腩腐膫臀腡膰臈腬膸腕腚腥膺膊膔腟腡膷腤膒腫腗腐臒臝腞腋腩腒腟腐膜膓腓腪腚腈腄腍腇 Helicobacter pylori, diagnostic test, PCR, +- CUBT 2+.*+2* 臗腸膘膦臎膇膝膈1./+ 腽腳臣臙 臗膽腶膄 Med. Bull. Fukuoka Univ.腈腃 ,2-, +,1+--, ,**+ 腌腊腃腅腋腆腎 ,2- P+,1P+--

Transcript of Evaluation of the Accuracy of Diagnostic Tests for ... · Evaluation of the Accuracy of Diagnostic...

Page 1: Evaluation of the Accuracy of Diagnostic Tests for ... · Evaluation of the Accuracy of Diagnostic Tests for HelicobacterPyloriInfection Hirokatsu N>H=>BJG6, Mitsuru S:D, Mitsuo O@696,

Evaluation of the Accuracy of Diagnostic Tests for

Helicobacter Pylori Infection

Hirokatsu N>H=>BJG6, Mitsuru S:D, Mitsuo O@696,

Motonobu K6C96, Motoko K6L6H=>B6 and Kazuo T6BJG6

Department of The First Internal Medicine, School of Medicine, Fukuoka University

Abstract : The aim of this study was to evaluate the accuracy of five diagnostic testsfor H. pylori. Each gastric specimen underwent PCR, culture and histological exam-inations. Serology and +-C�UBT analyses were also performed before or after en-doscopy. The sensitivity and specificity were as follows ; for PCR : 3240� and +**�,for culture : 3*4-� and +**�, for the histological examination : 204+� and +**�, for+-C�UBT : 3-4+� and 3/42�, and for serology : 3240� and 114+�. These results sug-gest that a combination of the above diagnostic tests would likely improve theaccuracy of detecting H. pylori infection.

Key words : Helicobacter pylori, diagnostic test, PCR, +-C�UBT

Helicobacter pylori �����������PCR �� ��� ��������� +-C�UBT� �����������

�� �� �� � � �� �� �� �� �� ��

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�� � H. pylori !"# /$%&'() *PCR )� +,)� -./0�1'(� +-C�UBT�2345)6 &78 9:;<='>?@A +,*B&CD E�FGH�IJKLM?� PCR)� +,)� -./0�1'(&@NOPQ��RSTU5V��RWXYZ -[\9]'?@A E�FGH�IJ&P^?_`a +-C�UBT STU2345)&@N&b2KMc@AY'(&d8�ef8`ghih� PCR )j 3240��+**�� +,)j 3*4-��+**�� -./0�1'( j 204+��+**�� +-C�UBT j 3-4+��3/42�� 2345) j 3240��114+�klc@A H. pylori mnopa&qrKm:;st?@uv�2345)&ef8`224+� Ew?@A 2345)`mna&qrKxN#yef8z{^|_� mna& H. pylori &}~ S:;`���kl#y��Xh@A mnopK�1y?@ H. pylori d�&}~ `+,)z��kl#z� }~&78K�"@N�'(y&/�v��z��kl#�yz���h@A

���� � Helicobacter pylori, diagnostic test, PCR, +-C�UBT

�2+.�*+2* �������1�./�+����

���� *Med. Bull. Fukuoka Univ.6 � ,2*-6, +,1�+--, ,**+

��� � �,2� - � � P+,1�P+--

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pylori �*+��,����- ��.� MALT

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+331�++RS)+333�+*ROD�.T/;�U0C�V�J4�W1��X�<=890YZ�([�� in-formed consent �2)�+,*3�([0,\� �����<=��54]++3 ���-33 ��.13 ^5_6� -3 �^5_6� 13 �� /3 �`!"#$ ,3 78� +3 �a!bc .3 ^5_6a!bc +3D:��� �Table +��9d�:eSD 5.3e+1f �+3g2,f� D;0-3 h/13D:���H. pylori *+i<�jk�:�([5 03 jk��4([5++.3D:���

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Dt�m���PCR �5 Agglutination Partition method �Sepa-

gene� :wxyE *+� 0F4� DNA 0Gzt Clayton )1� � ureA {H|0}b~��� �c���b �HPU�+ HPU�,� 0F4�m��� DNA poly-

merase 5 Ampli Taq� �#b�"���b USA� 0F4 3.� +*�r�c��"���b��t IJ�3.� +�r� ��b!"� �.,� +�r� KLM� �1,� +�r� 0-/����m4 �t�1,� +*

�r�a���"���b��"0�l �� �b������b5 PJ,*** �#b�"���b USA� 0�F �� PCR NO�P5 ,����b�~�DQ��Rt ���� ¡���¢�S0m4 .++bp �£"¢��1)�s�0T� � �Figure +�����8!589�mH�OD Hanks ¤�GIBCO, BRL, USA� � +g -*rUV �� ¥¦��§�¨b��¥¦��§�© �t Skirrow �W�XY �� ���"���b}b �ASTEC, BL�+0**, *+� 0F4 -1� Zª�«¬ � /�­[ +*�5­�\[ 2/�][� D /g 1*r�� �� ®��b�¯^ �� �S°D���b±²³ ´}�b±²³ µ��¶b±²³�TD:�s�0 H. pylori

T� �2������;�895· ¨�S�� H. pylori �+!J�o H. pylori _�ZAP��1)�s�0T� �� ��� ����;�89�`89�s=>1/

Table + Endoscopic diagnosis and the incidenceof H. pylori infection in +,* study pa-tients

Diagnosis n H. pylori positive

Normal ++ ,14-�Gastritis .1 /-4,�Duodenitis - 0041�Gastro�duodenitis 1 ,240�Peptic ulcer

Gastric ulcer ¸ +2 1142�Duodenal ulcer ¸ +3 1243�Combind ulcer ¸ , +**�

Malignant tumor

Gastric cancer / +**�Malignant lymphoma , /*4*�

Others 0 /*4*�

All patients +,* 0*4*�

¸ Includes ulcer scar.

�128�

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�� ��������� �� ���������H. pylori ��������

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assay EJ^_`a� F GHIJKLMNQ !$\ H.

pylori IgG \�)RS�� ELISA value �,4-XY�b�)�����+*Q�Thijs �0Q ��]!cde� PCR ]� fg]� hijklm�n� +-C�UBT� Z[\�]�� ,opXY��n]�����qrs) H. pylori ��� .tXY�

�n]�u��rs) H. pylori u��Sv��� w�n]�xy� z{y� ��|}m�V� u�|}m�V)~�� w�n]��y)@������

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1,/+,* E0*4*�Q ���� H. pylori ���.2/+,*

E.*4*�Q � H. pylori u������ H. pylori x��y���������134/� E-+/-3Q� ���+**�� �������/*�� ���/-4,�� ;����0041���;�����,240�� ���,14,����� ETable+Q�

������ ETable ,� -QPCR ]�� H. pylori �����1+/1,��� Exy

3240� � 3/� CI 3/43�+**�Q �� H. pylori u����.2/.2�u� Ez{y+**� � CI 3,43�+**�Q �����+�����u������ �� ��¡� .t��n]���������fg]�xy�z{y ECIQ �¢�£�3*4-� E2-4/�

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+-C�UBT �xy�z{y ECIQ � 3-4+� E214,�334*�Q� 3/42� E3*�+**�Q ����� �u�����

Figure + Detection of H. pylori DNA Elane +, ,,.Q

Table , Comparison of detection of H. pylori among diagnostic tests E�Q

Sensitivity Specificity PPV NPV

PCR 3240 E3/43�+**Q +** E3,43�+**Q +** E3.43�+**Q 324* E3.4+�+**QCulture 3*4- E2-4/�314+Q +** E3,43�+**Q +** E3.4/�+**Q 214- E124/�304+QHistological examination 314, E3-4.�+**Q +** E3,43�+**Q +** E3.4,�+**Q 304* E3*40�+**Q+-C�urea breath test 3-4+ E214,�334*Q 3/42 E3*4+�+**Q 314+ E3-4+�+**Q 3*4, E2,4*�324.QSerological test 3240 E3/43�+**Q 114+ E0/4,�234*Q 2040 E134,�3.4*Q 314- E3,4+�+**Q

PPVªpositive predictive value ; NPVªnegative predictive valueE Q 3/� Confidence Intervals

Diagnosis of H. pylori E«¬�¡Q �129�

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/���� .�������� ����� ,

������������� ������������ �CI� �3240� �3/43�

+**��� 114+� �0/4,�234*�� � ��� +�� ++�������

H. pylori �������� 0���� �Table /��� .�������� 0� !"#�$�%�&�'(���� ����������114+�()224+�*�+#�

� �

H. pylori �,�-.*�/��01�2345�� gold standard 6#��78��9:58 #(#� H. pylori �;<�=>#$?��*@�8$��'%� AB9*;<C8D6++�� �EF�G�HI�JKC8D6� L�M&E�;<C8NO�H�EPQ'7D6+,� ()D� ,������RSTUSVWXY�EZ8[\��8 D��]� ^I���� 2_`@a� H. pylori �, -.C8D6���6C8�b0�+-�+.� $c� d efghYijk�lmnXmS+/�+0� $op qr#�78 PCR ��s<tu9:�v5*�w�xp�7'7�Crayton1� )��by�� z]�{��|76xp�78 d � PCR � }]� H. pylori -.~���{�*�7���*��#��b�'7�]� PCR � }� /��� H. pylori -.~��*�7�o�-.\�{�*�#���� ���

PCR �����3240�� ����+**�c� ����#�/������G�$�p� H. pylori ��\ �#�7� PCR ����*|7{�����b0�1�+1�+2� 69�#�7� +���_��� �#�������������� D���6#�PCR ��F���0��xp*%7�� DNA �;<'�+3� ���)p� PCR ����* ¡8�]*¢£¤0E��¥*¦(*§¨#�H$��xp�c+3�,*�� PCR �©ª«S¬­®Y¯°S�EZ8[\��8 #(#'�)� H. pylori !H±*fc

Table - Result of H. pylori infection in +,* studypatients

HP PCR Cul His UBT Ser n �

positive

² ² ² ² ² /1 .14/�² ² ² ² ³ + *42�² ² ³ ² ² + *42�² ² ² ³ ² / .4,�² ³ ² ² ² 0 /4*�³ ² ² ² ² + *42�² ³ ³ ² ² + *42�

negative

³ ³ ³ ³ ² ++ 34,�³ ³ ³ ² ³ , +41�³ ³ ³ ³ ³ -/ ,34,�

Total +,* +**�

HP : H. pylori, Cul : culture, His : histological exami-nation,Ser : serological test, ² : positive, ³ : negative

Table . Accuracy of Histological detection of H.pylori ���

Sensitive Spcificity

� 314, �3-4.�+**� +** �3,43�+**�� 204+ �124+�3.4+� +** �3,43�+**�

� : One experienced pathologist examined all mate-arials

� : Some pathologists examined matearials� � 3/� Confidence Intervals

Table / Comparison of detection of H. pylori among diagnostic tests �exclude eradicated pa-tients�

Sensitivity Specificity PPV NPV

PCR 3240 �3/43�+**� +** �3+4,�+**� +** �3.43�+**� 3141 �3-4,�+**�Culture 3*4- �2-4/�314+� +** �3+4,�+**� +** �3.4/�+**� 2/41 �1/43�3/4/�Histological examination 314, �3-4.�+**� +** �3+4,�+**� +** �3.43�+**� 3/4/ �234.�+**�+-C�urea breath test 3-4+ �214,�334*� 3/4, �2241�+**� 314+ �3-4+�+**� 2243 �1341�324+�Serological test 3240 �3/43�+**� 224+ �124-�3143� 3-4, �214/�3243� 314- �3,4+�+**�

PPV´positive predictive value ; NPV´negative predictive value� � 3/�Confidence Intervals

�130�

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���������� H. pylori � coccoid form ����� �����������,,�

��� PCR �� H. pylori ������,-�,.� � ���� PCR ���������� ! "RFLP��#� H. pylori �$�%��,/�,0� ��� &�' ()���*�+,�-��.�/0�%��� � �1�� 2�34�2567(���� �89��:����; ���<5����� H. pylori �!� ="�>&?�@A���� �5B #�� � H. pylori C�D$%E&�F�'G(��H�� ,1� �8� C�D$IJBK���������L� � ���&��3*4-M��� Thijs N)O0� P02</1Q���*)O+2� ��+��Q�� Xia N,2� �C�D$R����ST�,��2</ U�I)O��5 � -VW�C�D$I?X�./IC5�0���%���Y#Z1234[�.\&��5]��6�/1Q�U�#� H. pylori C�D$�7.\� ���89^_����`aNb/1Q�� �1��PCR �&�����&�#�:+*M;b�5 U�#�� ���ST��/ %� H. pylori ���c<�����5�����defb�� gR�C�D$=h�>5'G(��?i�jC�@A�"k� ����fN�l��/Q�< U��BCfb �1234[�.\��m�34 ����� ��n ����D��12[opA�H�� 0�,3��qrVW�stu�DI�5� ��� v!wx!yz{ IE|F�GHI�JI ,}~1N".IJQ�� K�12[o� �����&��204+M�Q��� pA� +L���MN12�� �����&��314,M�Q�� UU�1N%1234[�.\ ���12[opA�H�� U��defb��

+-C�UBT �*)O-*��--� ��O�&� "3-4+M��5]� "3/42M� �%21Q�� SP�Id�� ,/�*.\�Q�T��Q�� +-C�UBT ���RS����� ����#�SP�I"k ����� �8� @'T�R���RI�0�UV� U�����fb�5 -*��--�� U ,./���RUV��0SP��"k��`aNb�� +-C�UBT �WX��/.\���� Y�5Z[\��]�.\��� � ��� ^�%2<� �QJ��� �����_I`�� U�1N H. pylori C�a�����-*��--� � � �1�� +-C�UBT �67(�25�5

BL#�� ��b=J���cd67(� U�1N H.

pylori &��[e\��5Nb U��f5� �1�� C�D$R����=J��2<-.�-/�� SP��/ ����� � ��� C�D$%E +ZgR%.*M�P�Id��5B)O%� �8-.�� C�D$R ���hi� �j-Y#Z� ������{�!+/�+0� %�k��5 � UVW�25&�"3240M� Id���5]��114+M� /�.\l�%d1Q�� SP��Q�++./R� 0/�C�D$I?X������� H. pylori �&��#�=J��25�`aNb�� �K� C�D$I?X� 0mIC5�0����U � 5]��114+M1N224+M�n¡�� "Table /�� *+,�8� H. pylori �!��=���I¢�="�>D$I?X�,o��m�C�fb������ 0� U�1N� £� //%SP��/Q�1%�b/5� �1�� �K�,o�="�>IT���5�1�o�Q�� &�¤<¥¦�2[oY#Zp�d§,o��b=J�ST��"k U��� +*�� -VWST��Q� +/�*.\��¨�P�©ª/%Z� U�1N&�¤<¥¦q«�� �`aNb��C�D$IF���� H. pylori &� ��������r� �� �^�I?��8*.\�3¬�­®���� U��defb�� ��� C�%E./� H. pylori �������5 �8���� 1234[�.\�� *.\��<N¨�ST��"k ����25� �K H. pylori C�Rp¯I¬�VW�j&�#�%js����25�fb�5 ,2�� H. pylori &� ���^��2<1��c� dX��/t��2C���� -VW /

�.\�u°1N +-C�UBT ��%h��5 �`aNb��

� �

H. pylori �±7(��²r�:�/v~w~�¬Nb � PCR ��&��5]��%�%2<� H.

pylori &� ����� �9���/5� +-C�UBT � PCR ��³5^��2<� ��� WX��� U�#� H. pylori &� ����� � ���� H. pylori 'G(�.´���/�8� C�D$Iµx�yb� H. pylori &� �����I¶-��K�.\�I�5�� ��¨·� �

Diagnosis of H. pylori "z{�*� �131�

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