鞠申AgMon重abTest㊥ 〔C
MO-80400125TESTS 。巧めSt胸堀。rian陶枕肋細[回
A rapid′ One SteP teSt for the qualitative detection of HelicoZJaCfer
pyZori (H.卿lon) antigens in human feces.
For professional in z履ro diagnostic use only.
ll一・ ‘1 /i励¥.: M`‘i-i-l、il"StQ iS ‘一`a【-一d (l一〇一I。一“itograI一一一i、
i。lilll-i一一i-SSav to- tl一・ ` lliiil・一ti、・" d・'一・。i・一l一一一I且pl/l《'7事.一l-llger`S m
l-1一一l一・一一一l`‘I ‘'` SPe( ll一一一ilSt。 Ild ii- tl-t d一・即・棚。f見f7]/硯I-1ie{ll一'一1
囲めbacfeγ pリZo71 q卿Zo予y〉 is a small, SPiral-Shaped bacterium血at
is found in血e §urface of the stomach (epi血elial lining) and
duodenun (mucous layer). H. pyZoγi causes duodenal ulcers and
gas血c血ce富s.
The importan⊂e Of rmcobac卸卿lon testing has increased greafty
Since血e strong correlation between血e pre§en⊂e Of bacteria and
COnfirmed gastrointes血al diseases (stomach and duodenum) 1ike
gas血tis′ PePtic ulcer disease and gastric carcinoma.血LVaSive and
non-invasive methods are used to diagnosis H nyforf infee[ion in
Patients with symptoms of gastrointestinal disease.
」曲e
Store as packaged in the sealed pouch either at refrigerated or room
temperature (2-30OC). The test is stable血rough the expiration date
Printed on the sealed pouch. The test must remain in血e sealed
POuCh until use. Do not freeze.
書誌器器。ry 2。23 ㌦豊監護蓋nfab SL C/Co軸o 74 08940 Corne畦uobregat (闘ona′ Spain) +34 93 433 58 60 Fax +34 93 436 38 9固唾麺塑al麺曲
Collect su鯖cient quantity of feces (1-2 g or mL for liquid sample).
StooI samples should be collected in clean and dry containers (no
PreServatives or transport media).
The und血ted samples can be stored′ for l year′ in the refrigerator
(2-80C/3646.4OF) or frozen at -20OC/-40F. It is recommended to
freeze for longer storage・ In this case′ the sample wi11 be tota11y
thawed′ and broug匝to room temperature before testing.
The diluted samples wi血buffer can be stored for l week at room
temperature (approx. 21OC/70OF) or in the refrigerator (2-8OC/36-
46.40F). It is recommended that wherever possible′ keeping samples
refrigerated.
To proces§血e colleぐted stoo書samples (See il]ustration l):
Use a separate specimen collection vial for each sample. Unscrew
血e cap of the vial and introduce the stick′ Only血e part of the
PrOPeller and as vertical as possible, four times into the same faecal
SPeC血en to pick up quite a lot of sample (approx・ 50 mg). Close the
Vial wi血the buffer and stooI sample. Shake血e vial in order to
assure good sample dispersion. For liquid stooI samples′ aSPirate
瓜e fa∝al specimen wi血a dropper and add 125prL into the
SPeCimen co皿ection vial wi血buffer.
Test Procedure (see illustration 2)
Ailow the tests′ StOOl §amPles and buffer to reach to room
0上止敦血中曲調hes u皿宜し
1. Remove血e H. z’yloγi Ag MonlabTest⑱ from its sealed pouch and
use it as soon as possible.
2- Shake the specimen collection vial to assure good sample
dispersion- Break off the亀p of血e via⊥
3. Use a separate device for each sample. Dispeuse exactly 3 drops
into血e specimen we皿(S). Start血e timer.
4. Read the result at lO minutes after dispensing血e sample.
IⅡus血a債on l
Pickupthesample Mixthesample
Withbl竜虎重
耳E
瑚 掴 里 ×・50mg Breakthe
哩皿哩e十脚 理
∴ ∴l
 一 ∵
鱒蹄鞘闘輔

Illustration3

日子 当∴ ∴ -j Detection limit
The range for the detection limit values for H. p3/ioγi Ag
POSITIVE NEGATIVE INVALID INVALID
MonlabTest㊥ is between O.78-0.09 ng/mL of H. WZo7? recombinant

POSFTIVE: Two lines appear across血e ceutral window′ in the
result line re豆on (a red test line marked with the letter T) and in血e
control line region (a green control血e marked with the letter C).
NEGATIVE: Only one band appears across the control line region
outer membrane protein.
Sensitivity and Specificity
It was performed an evaluation using H.砂ioγi Ag MonlabTest⑧
with specimens obtained from patients with the same as H. WZoγi

marked wi血the letter C (control line). infection symptoms and from asymptomatic individuals. The H.

INVALID: A total absence of the controI coIoured band regardless 卿zorj Ag Mo血abTest⑧ was evaluated compared with a commercial

the appearance or not of the test line. Note: Insufficient specimen qpcR kit (助icobacteγ砂oタイReal Time Detection Kit)・

volume′ incorrect procedural tec量miques or deterioratien of the

qpcR:HeJicobacter砂vorZRealTimeDetection
reagents are the most likely reasons for contro1 1ine failure. Review
kit
the procedure and repeat the test with a new test. If血e problem

persists′ discon血ue using the test kit and contact your local 十 54 1 55
ICtest:H型/Jori AgMonlabTest⑧ 十 Total
distributor.
1 60 61
Total 55 61 116

H.卿JoγiAgMonlabTest⑪vsHencoZ,aCfer砂わri
The iritensity of the red ⊂OIoured band in the result line region O RealTimePCRDetectionKit
wi11 vary depending on the concentration of antigens in血e 95%C重
specimen. However′ nei血er血e quantitative value′ nOr the rate of (Corfidenceinterval)
increase in antigens can be determined by址s qualitative test. Sensi瞳vi吋 98.2% 90.3%-100,0%
Spec並iぐi吋 98.4% 91.2%-100.0%
PPV 98.2% 90.3%-100.0%
QUALITY CONTROL
NPV 98,4% 9l.2%-100.0%
Intemal procedural controIs are ineluded in士he test:
- A green line appearing in the contro=ine region (C). It confirms
Cr oss-Reactivity
sufficient specimen volume and correct procedural technique. It was perfomed an evaluntion to determine the cross reactivity of
H・相加Ag MonlabTest⑧∴mere is not cross reactivity with
common intestinal pathoge叫y other organism§ and substances

∝CaSionally present in feces.

1.H. pyf諦Ag Mor心bTest㊥ w皿only indicate血e presence of H.

即/如扉in the specimen (qualitative detection) and should be used

Adenoひiγ躍 東Gbo窃m(immunqgiobunms)
for the detection of H. mZon antigens in feces specimens only.
αmpγiobacteγCO砺eiuni Liste7高まmOnOCl/tO又eneS
Neither the quantitative value nor the rate of increase in H.卿Zo7i

antigens concentration can be determined by皿s test. Cわs諦dilImd砺dね 5aimoneiiaenteγ拐di夕

pamtl仰h狗仰h励hiγm諦um
2.An excess of sample could cause wrong results (brown bands
appear). Dilute the sample with the buffer and repeat the test. どsd拡房d夢iaconO工57:H7 S穣e脇boydii
〃γSenteタイaq伊e尤neγ妨omei
3. Some stooI samples can decrease the intensity of the control line. Gね1diaきamb脆a 5taph所ococ側SauγeuS
HCGho肋u)mf均man YとγSiniaenteroooiiti∽
4.If the test result is negative and clinical symptoms persist′
α重0γわnicGomdotro章1in)
additiorral testing using other clinical methods is recommended・

A negative result does not at any time preclude the pos§脚ity of

H鋤や如0坊mhumm

H・ pリioγi infection.

5・ This test provides a presumptive diagnosis of H. pyioγi infectious.

1-Cutler AF. Testing for HdicoZ,aCter PyZo汚in clihical practice. An待
All results must be interpreted together wi血o血er dinical
勅ed. 1996i l(調:35S-41S
information and laboratory丘ndings avaぬble to the physician.
2-SoIL AH. Pathogenesis of pectic ulcer and implications for
6. Mucous and/or bloody stooI samples could ・auSe nOn-SPeCific
theraphy. New England J. Med. (1990), 322: 909-16.
reactions in the test. Mucous and/ or bloody stooI samples whose
3-Ma血J. Blaser. Heiicobacteγ pUZon and gastγic虎scases. BMJ声16:
result is positive should be followed up with o血er tedmiques to
1507-1510 (1998).
confirm the result.

獲 Manufacturer 園芸三豊rOdlag_tic
回 Dontie-uSe 関霊霊tinstructious

▽n =霊Suffieientfor f Keepdry

回 Catalogue Code 才 Temperature limitation

回 LotNumber E useby

嵩認諾器ry 2。23 ul盤iab SL qCobaito 74 08940 Corne畦]obregat (Barcetona′ Spa n) +34 93 433 58 60 Fax十34 93 436 38 94 Q辿i踵哩蛙幽