review article: clinic-based testing for helicobacter pylori infection by enzyme immunoassay of...

Review article: clinic-based testing for Helicobacter pylori infectionby enzyme immunoassay of faeces, urine and saliva

S. KABIR

Academic Research and Information Management, Stockholm, Sweden

Accepted for publication 9 March 2003

SUMMARY

Enzyme immunoassays have been used to detect

Helicobacter pylori infection in human body materials

such as faeces, urine and saliva. The stool antigen

assay (HpSA), which uses polyclonal anti-H. pylori

antibody as a capture reagent, has been widely used in

the pre-treatment diagnosis of the infection in adults

and children. Although the assay has the potential for

monitoring eradication therapy, there are controversies

over its use, especially at an early stage after

treatment. The efficacy of the stool antigen assay can

be modified by using monoclonal antibodies towards

well characterized H. pylori faecal antigens. Two types

of enzyme immunoassays (enzyme-linked immunosor-

bent assay [ELISA] and immunochromatography) have

been used to detect antibodies to H. pylori in urine.

Immunochromatography of urine is a rapid assay well

suited for epidemiological studies. The salivary ELISA,

used in a number of studies, has shown inconsistent

results with less than optimum sensitivity and specif-

icity. Urinary and salivary immunoassays may not

distinguish between past and present infections, thus

limiting their potential to monitor eradication therapy.

INTRODUCTION

Helicobacter pylori is a Gram-negative flagellate bacter-

ium that is regarded as a major pathogen in gastritis,

gastric and duodenal ulcers, gastric carcinoma and

mucosa-associated lymphoid tissue (MALT) lym-

phoma.1, 2 Approximately half of the world population

is infected with H. pylori,3 even though most infections

are asymptomatic. A close association exists between

infection with the bacterium and gastric cancer.4

Diagnostic tests currently used for the detection of

H. pylori fall into two categories: invasive and non-

invasive, the former requiring endoscopy. The invasive

methods, which are biopsy-based, include culture, rapid

urease test (RUT) and histology. Non-invasive testing for

H. pylori can be done by the urea breath test (UBT),

serology and analysing body materials such as faeces,

urine and saliva. UBT requires instruments such as mass

spectrometer, scintillation counter and infrared spectro-

meter, which are not always available in routine clinical

laboratories. Enzyme immunoassays, which are simple,

reproducible and inexpensive, can detect either antigen

or antibody. Although serum-based enzyme immuno-

assay has been used to detect H. pylori infection,5 it can

not distinguish between past and present infections as

antibody titres decline very slowly even after successful

H. pylori eradication.6 The assay requires blood collec-

tion, which is not always suitable for children. Human

body materials such as faeces, urine and saliva, which

are collected by totally non-invasive procedures, have

been subjected to enzyme immunoassays for the diag-

nosis of H. pylori infection. Although reviews on faecal

testing by enzyme immunoassay covering the early

literature have appeared,7, 8 no review summarizing the

application of enzyme immunoassays of urine and saliva

has yet been published. The present review summarizes

Correspondence to: Dr S. Kabir, Academic Research and Information

Management, Tobaksspinnargatan 5, 11736 Stockholm, Sweden.

E-mail: [email protected]

Aliment Pharmacol Ther 2003; 17: 1345–1354. doi: 10.1046/j.0269-2813.2003.01577.x

� 2003 Blackwell Publishing Ltd 1345

our current knowledge on the clinic-based testing for

H. pylori infection in faeces, urine and saliva by enzyme

immunoassay.

FAECAL DETECTION OF H. PYLORI ANTIGENS

BY ENZYME IMMUNOASSAY

Bacterial culture, the polymerase chain reaction (PCR)

and enzyme immunoassay have all been used to detect

H. pylori in the faeces.7 While culture offers maximum

specificity and accuracy in identification, it is very

difficult to grow H. pylori from the faeces. PCR requires

special laboratory facilities and is not suitable in the

routine clinical setting.9 Sandwich enzyme immuno-

assay has been used to detect H. pylori antigens in the

faeces, and two commercial kits are currently available.

Stool antigen enzyme immunoassay (Premier Platinum

HpSATM)

Premier Platinum HpSA is a commercial kit based on

the principle of sandwich enzyme immunoassay

(Premier Platinum HpSA Test, Meridian Diagnostics,

Ohio, USA; US patent no. 5716791). A polyclonal

antibody to an H. pylori strain (ATCC 43504) can

detect the bacterium in different geographical regions

and dietary groups.10 This antibody, adsorbed to

microwells, acts as a capture reagent in the immu-

noassay.

Pre-treatment diagnosis of H. pylori infection in adults

and children by HpSA

Several studies in adults using HpSA have produced

results with high sensitivities and specificities11–24

(Table 1). H. pylori infection appears to be acquired in

early childhood, and about 90% of children with

duodenal ulcers are infected with H. pylori.25 Biopsy-

based tests are not convenient for children, as endo-

scopy may necessitate sedation or general anaesthesia.

Besides, false-positive results can occur with UBT in

younger children, affecting the accuracy of the test.26

Faecal testing is particularly suitable for children, as

faeces can be obtained from them without their active

Table 1. Evaluation of the HpSA test for

the pre-treatment diagnosis of H. pylori

infection in adults and children

References Patients (no) Gold standard Sensitivity (%) Specificity (%)

Adult populations

Vaira et al.11 501 RUT, H, C 94 92

Ohkura et al.12 309 RUT, H, UBT 94 96

Trevisani et al.13 300 RUT, H 97 90

Forne et al.14 188 RUT, H, UBT 89 78

Trevisani et al.15 146 RUT, H 94 90

Vakil et al.16 108 RUT 86 91

Monteiro et al.17 104 RUT, H, C 89 94

Lehman et al.18 102 RUT, H, C 96 93

Makristathis et al.19 100 UBT, S 89 95

Braden et al.20 90 UBT 92 97

Fanti et al.21 84 H, C 98 96

Puspok et al.22 72 H 80 98

Agha-Amiri et al.23 54 RUT, H, UBT, S 96 92

Chang et al.24 62 H, C, UBT, RUT 94 89

Child populations

Kato et al.27 264 UBT 96 97

Oderda et al.28 203 RUT, H 100 93

Braden et al.29 162 UBT 92 99

Konstantopoulos et al.30 145 RUT, H, C 89 94

Shepherd et al.31 119 UBT 88 82

Gosciniak et al.32 107 RUT, C 89 96

van Doorn et al.33 106 H, C 100 92

Makristathis et al.34 78 UBT, S 94 97

Rothenbacher et al.35 69 UBT 85 98

Husson et al.36 58 H, C 87 97

C, culture; H, histology; RUT, rapid urease test; S, serology; UBT, urea breath test.

1346 S. KABIR

� 2003 Blackwell Publishing Ltd, Aliment Pharmacol Ther 17, 1345–1354

collaboration. HpSA produced a high degree of sensi-

tivity and specificity in detecting H. pylori infection in

children27–36 (Table 1). The European Helicobacter

pylori Study Group has recommended the use of HpSA

in the initial diagnosis of H. pylori infection.37

Post-treatment diagnosis of H. pylori by HpSA

Four or more weeks after therapy. The efficacy of

eradication therapy is generally tested by UBT after a

minimum of 4 weeks. Recently HpSA has been used to

monitor eradication therapy. A number of studies

monitored four or more weeks after therapy demon-

strated high sensitivities and specificities, suggesting

that HpSA can be used to determine the efficacy of

eradication therapy (Table 2).

Less than 2 weeks after therapy. A group of H. pylori-

infected patients in a multi-centred study were subjected

to HpSA on various days until day 35 after the

completion of therapy.43 On day 7 after treatment, the

stool antigen test was predictive of eradication (positive

predictive value, 100%; negative predictive value 91%),

suggesting that a positive HpSA test shortly after the

completion of eradication therapy identifies patients in

whom therapy for H. pylori was unsuccessful.

HpSA has been used to monitor eradication treatment

in children with gastritis.46 The sensitivity and speci-

ficity of HpSA on stools obtained 2 weeks after therapy

were 100%, suggesting that HpSA can be used to

monitor treatment efficacy as early as 2 weeks after

therapy. Similar results of high sensitivity and specificity

with HpSA in adults at an early stage after treatment

have been reported in a Japanese study.44

Controversies related to HpSA’s reliability

in monitoring eradication

A number of studies have questioned the efficacy of

HpSA in monitoring the outcome of the eradication

treatment. When patients in a study were monitored

1 month after therapy, HpSA offered a low specificity of

68%, indicating that 1 month may not be the ideal time

to monitor eradication efficiency.19 HpSA performed 8

and 12 weeks after the end of therapy did not produce

any false-positive results.34 Another study showed that

the diagnostic accuracy of HpSA increased from 82% to

97% when patients were monitored at 1 and 3 months

Table 2. Evaluation of HpSA test for the

post-treatment diagnosis of H. pylori infec-

tion in adults and childrenReferences

Patients

(no)

Time

(weeks)

Gold

standard

Sensitivity

(%)

Specificity

(%)

Adult populations

Vaira et al.38 235 4 UBT 96 95

162 4 RUT, H, C 93 95

Ishihara et al.39 112 4 UBT 90 98

Manes et al.40 106 4 UBT 87 95

Braden et al.20 115 4 UBT 91 95

Makristathis et al.19 55 4 H,C 86 68

Arents et al.41 65 4 UBT 40 95

Leodolter et al.42 30 4–6 UBT 93 94

Vaira et al.43 84 5 RUT, H, C 94 97

Odaka et al.44 43 2 H,C,UBT 89 91

6 89 97

Trevisani et al.15 116 8 RUT, H, UBT 93 82

Forne et al.14 142 6 UBT 70 82

Costa et al.45 155 4 RUT, UBT, H 92 82

153 13 96 97

Child populations

Gosciniak et al.32 62 4–6 RUT, C 89 96

Oderda et al.46 60 2 UBT 100 100

6 100 94

Makristathis et al.34 40 4 UBT 100 93

8 100 100

Husson et al.36 11 5–6 H, C 67 100

C, culture; H, histology; RUT, rapid urease test; UBT, urea breath test.

H. PYLORI DIAGNOSIS IN FAECES, URINE AND SALIVA 1347


after treatment, suggesting that a longer period of

follow-up may be appropriate for monitoring eradica-

tion therapy.45

HpSA showed higher sensitivity and specificity in

untreated patients compared to those observed in

treated patients.15 It offered a pre-treatment sensitivity

and specificity of 96% and 82%, respectively, among

128 H. pylori-positive patients.41 However, when the

test was performed in 65 patients who had received

eradication treatment, it showed a sensitivity of 20%

and 40% 1 and 4 weeks after treatment. The low

sensitivity might be due to the presence of insufficient

antigen load in faeces, as the eradication treatment

could suppress the growth of bacteria.

Although a favourable correlation between 13C-UBT

and HpSA has been demonstrated in a group of

untreated patients,24 the discrepancy between the two

tests was significantly greater in treated patients.47, 48

This might be because UBT measures a metabolic

function of the bacterium (i.e. urease activity), while

HpSA can detect H. pylori antigens from the coccoid

form and/or of degenerate forms of dead bacteria over a

prolonged period in faeces. Besides, HpSA can cross-

react with antigens from other non-pylori Helicobacter

species which may colonize the human stomach.49

A recent multicentre-based study has observed reduced

accuracy of HpSA in comparison to UBT.50 Also the

study failed to detect any coccoid forms of H. pylori in

most of the endoscoped patients with negative UBT and

positive HpSA, thus necessitating further study to clarify

these discrepancies.

Controversies among the studies related to HpSA’s

efficacy in monitoring eradication have been suggested

to have arisen out of the use of gold standards.51 While

two tests (RUT and histology) or culture have been used

as the gold standard to claim reliability of HpSA in

monitoring eradication therapy,38 a single test such as

UBT has been used as a gold standard in a study that

has disputed HpSA’s efficacy in eradication therapy.14 It

is possible that a single test as a gold standard can

increase error.

Advantages and limitations of HpSA

HpSA is suitable for the pre-treatment diagnosis of

H. pylori infection in adults and children. It is ideal for

screening as well as for epidemiological studies. It does

not require any specially trained technician to

perform. Results can be obtained rapidly, within

approximately 2 h. Although the test results are read

by a spectrophotometer, the colour developed can also

be monitored visually.28 Stool specimens kept frozen at

)70 �C for up to 7 months can be satisfactorily tested

by HpSA.52 H. pylori-infected patients can be treated by

general practitioners, who may utilize HpSA as a cost-

effective near-patient kit.53

HpSA is a qualitative test that does not offer any

quantitative evaluation. The cutoff point in the assay as

provided by the manufacturer does not always offer

satisfactory results, as investigators had to determine

the best cutoff point by receiver operating characteris-

tics (ROC) curves.12, 27, 42, 54 It should not be applied to

patients who are on medications containing antimicro-

bials, proton pump inhibitors and bismuth preparations,

as these substances may suppress the growth of

H. pylori and cause false-negative results.55, 56 While

the test has been accepted for the pre-treatment diag-

nosis of H. pylori infection, its use in early monitoring of

treatment efficiency remains controversial, making UBT

the recommended first-line post-treatment diagnostic

test.37, 57 What the test actually detects in the faeces

has not been established. It is possible that the test

detects either living or dead H. pylori and partially

digested bacteria from the stomach. According to the kit

manufacturer, HpSA is highly specific and does not give

false-positive results when test materials are spiked with

a number of other enteric organisms. However, cross-

reactivity of the assay with non-pylori Helicobacter

species colonizing humans has not been tested. Stool

handling can be problematic with adult patients, thus

questioning patient compliance of HpSA in routine

clinical practice.58 The kit’s application in large parts of

the developing world, where the prevalence of H. pylori

is very high, has not been adequately reported. It has

not been validated for use on watery diarrhoeal stools,

despite the fact that diarrhoeal episodes are very

common in developing countries.

Stool antigen enzyme immunoassay

(FemtoLab H. pyloriTM)

Another stool enzyme immunoassay kit (FemtoLab

H. pyloriTM, Comex GmbH, Germany), which uses a

mixture of monoclonal antibodies (MoAbs) against

H. pylori antigens, has shown high levels of sensitivity

(96–98%) and specificity (88–97%) in the pre-treatment

diagnosis of H. pylori infection.34, 59 When used to

monitor eradication after treatment, the assay produced

1348 S. KABIR


specificity of 97% with stool specimens obtained

4 weeks after therapy. This value increased to 100%

with samples collected 6 and 8 weeks after the end of

treatment.34 FemtoLab H. pyloriTM showed a greater

distinction between positive and negative results in

comparison to that obtained by the Premier Platinum

HpSA EIA.34, 60 Only a limited number of reports using

this kit are available in the literature, and more

multicentre-based studies are needed to establish the

acceptability of this kit.

MoAbs against coccoid H. pylori cells were raised in

mice to produce one kind of MoAb recognizing a faecal

H. pylori antigen.61 This MoAb produced a positive

reaction in a direct enzyme immunoassay against 41

clinical H. pylori isolates and faecal specimens from

seven H. pylori-positive patients. Preliminary studies

indicate that the MoAb recognizes H. pylori catalase

present in human faeces.62

URINARY ENZYME IMMUNOASSAYS

Two types of enzyme immunoassays, namely ELISA and

immunochromatography, have been used to detect

antibodies to H. pylori in urine.

Urinary ELISA

H. pylori immunoglobulin G (IgG) was first detected

by ELISA in urine of a number of patients undergo-

ing endoscopy using a mixture of H. pylori-specific

protein as antigens.63 The assay provided results

with high sensitivity and specificity (Table 3). When

urine samples were analysed by the Western blot

method, a great variation in antibody response was

observed, each patient producing a unique antibody

pattern.

A number of studies have used a commercial ELISA

kit (URINELISA, Ostuka Pharmaceutical, Tokyo,

Japan) to detect H. pylori antibody in human

urine64–68 (Table 3). The assay plates contained

antigens from an H. pylori strain having important

genes such as vacA, ureB and cagA. Sensitivity and

specificity of URINELISA were found to be high.

Infants below 1 years of age were positive for

H. pylori IgG, but negative for H. pylori immunoglobulin

A (IgA).68 It is possible that IgG-seropositive infants

were false-positive, as they might have acquired

H. pylori-specific IgG antibodies transplacentally from

their mothers.

Immunochromatography

RAPIRUN, a commercial kit (Ostuka Pharmaceutical,

Tokyo, Japan) based upon the principle of immuno-

chromatography, has been used in a few countries as a

near-patient test kit for the detection of H. pylori

antibody in urine.69–74 It has offered results with high

sensitivies and specificities (Table 3).

Advantages and limitations of urinary enzyme

immunoassays

Most of the studies using urinary enzyme immunoassays

have demonstrated an accuracy comparable to that of

serum-based ELISA for the detection of antibody to

H. pylori. Urine-based enzyme immunoassays are advan-

tageous as these tests are non-invasive and the sample

collection is very simple. In addition, antibodies to

H. pylori in urine are stable for 60 days at 4 �C and for

3 days at 37 �C, thus making routine transportation

of urine samples to laboratories convenient.66 In

URINELISA antibody activity in random single-void urine

in individuals was relatively constant during a day and on

different days, except for first-void morning urine.64 In a

serum-based ELISA, sample preparation is lengthy, as it

involves blood collection and separation of serum. In

contrast, urine can be applied directly in enzyme

immunoassays, thereby reducing the length of time to

obtain results. RAPIRUN takes only about 20 min to

Table 3. Evaluation of urinary enzyme immunoassays for diag-

nosing H. pylori infection

Reference

Patients

(no)

Gold

standard

Sensitivity

(%)

Specificity

(%)

Urinary ELISA

Alemohammad et al.63 306 H, RUT, C 96 90

Kato et al.64 238 H, RUT, C 96 79

Miwa et al.65 132 UBT 86 91

Katsuragi et al.66 119 UBT 99 100

Adachi et al.67 100 UBT 91 95

Kato et al.68 816* S 85 95

Immunochromatography

Miwa et al.69 155 UBT 96 88

Wong et al.70 123 H, RUT 97 95

Yamamoto et al.71 117 H, S 92 93

Graham & Reddy72 104 UBT 95 97

Wu et al.73 93 H, RUT,

C, UBT

95 90

Fujisawa et al.74 21 H, RUT, C 100 67

C, culture; H, histology; RUT, rapid urease test; S, serology; UBT, urea

breath test. *Children.



complete, thus helping patients to proceed to the next step

for investigation. It is a qualitative test that may suffer

from a few drawbacks. Although it can be used with

randomly collected urine samples, too much water intake

before urination should be avoided as it can produce urine

with a very low concentration of IgG, thus producing

invalid tests. Proteinuria can contribute to false-positive

results, suggesting that patients with proteinuria should

be examined by other tests.63, 68 The two urine-based

assay systems produced sensitivies and specificities which

were found to be higher than the stool antigen assay

HpSA.67 Urine samples should not be kept frozen, as the

sensitivities of URINELISA and RAPIRUN with such

specimens were very low.67 Urine samples kept at 4 �C for

up to 18 months offered satisfactory results.

Like serology, urine tests may remain positive for an

extended time after successful eradication of the infec-

tion, thus giving false-positive results. Urine based

immunoassays are suitable for screening and large-

scale epidemiological studies concerning the prevalence

of H. pylori infection. Antigens used in URINELISA and

RAPIRUN were from an H. pylori strain (OHPC-040)

isolated from a Japanese patient. Since there is genetic

diversity among H. pylori strains,75 the test kit should

use antigens from H. pylori strains obtained from

different geographical regions. Additionally, more multi-

centre studies should be carried out in order to

determine the acceptability of these kits.

SALIVARY ENZYME IMMUNOASSAYS

Detection of H. pylori infection by salivary IgG ELISA

Since saliva can be obtained easily, it has been analysed

by enzyme immunoassay to detect antibodies to

H. pylori. Saliva contains IgA and low levels of IgG,

the former being produced locally by salivary glands.76

The salivary IgG is mainly derived by transudation from

blood to gingival fluid. The presence of H. pylori-specific

IgG in saliva was first detected by ELISA in a group of

patients undergoing gastrointestinal endoscopy.77

Salivary IgG distinguished between H. pylori-positive

and -negative cases, while salivary IgA did not. The

sensitivity and specificity of the assay using salivary IgG

were both 85% and were found to be better than those

obtained by salivary IgA (sensitivity 76%, specificity

61%). Although a good correlation existed between

salivary IgG and serum IgG in this study, a number of

subsequent studies showed that the sensitivity and the

specificity of the salivary IgG measurements were

inferior to those of the serum IgG assay (Table 4).

While salivary IgG testing showed promise in screening

a group of selected dyspeptic patients before endo-

scopy,77 it is not considered as a procedure to screen

patients for endoscopy in general practice, as false-

negative results obtained by the salivary IgG assay are

significant. IgG, which appears in saliva by transcapil-

lary leakage, is present in low concentration as

compared to that present in serum. Factors such as

the low concentration and variable transcapillary

leakage may make the salivary IgG assay less reliable

than the serum IgG assay.

Oral fluid, a complex mixture of saliva, gingival

crevicular fluid and secretions from the mucous mem-

branes, has been used in ELISA to detect H. pylori-specific

IgG.79 Results obtained with the assay performed on

adults were superior (sensitivity 94%, specificity 85%) to

other salivary ELISA results, the performance being

similar to that of the serum IgG assay. This is probably

because the IgG concentration in oral fluid is higher

Table 4. Evaluation of the salivary and

serum ELISA for diagnosing H. pylori

infection

References

Patients

(no)

Salivary ELISA Serum ELISA

Sensitivity

(%)

Specificity

(%)

Sensitivity

(%)

Specificity

(%)

Patel et al.77 119 85 85 90 90

Luzza et al.78 213 81 73 90 78

Luzza et al.85 152 82 71 97 91

Christie et al.86 86 88 71 85 78

Simor et al.87 195 81 75 n.d. n.d.

Fallone et al.88 106 66 74 66 83

Reilly et al.89 303 84 70 95 70

Loeb et al.90 157 86 58 n.d. n.d.

Marshall et al.79,* 81 94 85 91 91

n.d., not determined; * Oral fluid used.

1350 S. KABIR


than that in whole saliva.76 When oral fluid samples

from children were analysed by ELISA to detect IgG

antibodies to H. pylori, variable results were obtained.80

Children aged 0–4 years displayed very low sensitivity

(33%), which improved to 81% in children aged

5–18 years. Therefore oral fluid ELISA may not be

suitable for the diagnosis of H. pylori infection in

children, especially those under the age of 5 years.

Because of ease of sample collection, salivary testing

may have a role in epidemiological studies in children in

whom venipuncture is more difficult and blood samples

are not easily available. The salivary anti-H. pylori IgG

was determined in a large number of German school

children (477, age 5–6 years) by a commercial ELISA

kit (HM-CAPTM; Enteric Products Inc., Stony Brook,

NY), and satisfactory results (sensitivity 81%, specificity

95%) were obtained.81 In another study involving 112

Italian children (2–18 years) the salivary IgG assay

showed significantly higher IgG levels in H. pylori-

positive children than in H. pylori-negative children, the

sensitivity and specificity of the assay being 93% and

82%, respectively.82 These results suggest that the

salivary IgG assay may be used as a tool to screen

children in epidemiological studies. However, another

study involving 287 asymptomatic children showed low

sensitivity (65%) and high specificity of the salivary IgG

assay (98%).83 A commercial salivary ELISA kit was

used in an epidemiological assay to detect the preval-

ence of H. pylori in school children from Sri Lanka, and

the results were compared with those obtained by the

stool antigen assay.84 While the rate of prevalence

detected by the stool antigen assay was 6%, that

detected by the salivary ELISA assay was 28%.

Advantages and limitations of salivary enzyme

immunoassays

The collection of saliva is rapid, uncomplicated and no

specialized technician is required. It can be collected by

patients themselves and therefore leads to greater

patient compliance than blood drawing. While in a

serum-based ELISA serum has first to be separated from

blood, saliva can be used directly for analysis.

Salivary IgG assay has provided inconsistent results

with less than optimum sensitivity and specificity. Since

the IgG concentration in saliva is low, care should be

given in sample collection and handling so that an

adequate amount of IgG is obtained. Also, the collected

IgG should be protected from bacterial growth and

proteolytic breakdown of immunoglobulins. Specialized

collection devices that enhance the level of immuno-

globulins in saliva are now available commercially.

However, a number of studies have obtained unstimu-

lated saliva without using any devices. Therefore more

work is needed to standardize assay protocols so as to

avoid controversies. Since oral fluid contains more IgG

than that present in saliva76 and has provided better

sensitivity and specificity in adults,79 it may be used to

detect H. pylori infection in adults.

CONCLUDING REMARKS

Use of body materials such as faeces, urine and saliva,

instead of whole blood and serum, reduces the potential

danger that health care professionals encounter through

blood exposure. The stool antigen assay is suitable for the

pre-treatment diagnosis of H. pylori infection and has

potential for monitoring eradication therapy. However,

more studies are needed to clarify the controversies over

its use, especially at an early stage after treatment.

Immunochromatography of urine offers a rapid assay to

detect H. pylori infection. It is well suited in epidemio-

logical studies related to the prevalence of H. pylori

infection. Although the salivary IgG assay has shown

inconsistent results, the use of oral fluid can offer

encouraging results in adults. Antibody-based immuno-

assays can not distinguish between past and present

infections. Therefore enzyme immunoassays using urine

and saliva are not suitable to monitor eradication

therapy. The stool antigen assay using monoclonal

antibodies can offer better distinction between positive

and negative results. Therefore the efficacy of the existing

stool antigen assay kits can be further modified by

characterizing the H. pylori antigens present in the faeces

and using monoclonal antibodies towards such well

defined antigens as capture reagents in immunoassay.

DECLARATION

This work did not receive support in any form (i.e.

financial, share holdings, consultancy fees) from the kit

manufacturers mentioned in the study.

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1354 S. KABIR


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