ORIGINAL ARTICLE
Medex Test, a Novel Modality for Liver Disease Diagnosis
A Pilot Study
Yoav Lurie, MD,* Dan-Avi Landau, MD,* Alex Kanevsky, MD,w Sara Pel, BA,*
Shira Zelber-Sagie, BSc,* and Ran Oren, MD*
Background and Aims: Liver diseases are associated with
significant morbidity and health– related expenditure. Although
cost-effective treatments are available, the disease is often
asymptomatic until late in its course. ‘‘Medex Test,’’ is the
noninvasive detection of liver abnormalities by the measurement
of changes in electrical impedance of dermal zones. This method
is based on neuroreflexology, a branch of complementary
medicine. This study addressed 2 questions: can Medex Test
detect liver disease, and can it measure the severity of a known
liver disease.
Methods: This blinded case-control study included 2 parts. First,
113 patients with a known liver disease (hepatitis C, hepatitis B,
and nonalcoholic fatty liver disease) and 85 controls with no
known liver disease were evaluated by the Medex Test device.
Second, necroinflammatory grading of biopsy results of 60
patients with chronic hepatitis C were compared with grade
determined by Medex Test.
Results: Medex Test detected with high sensitivity (85%) and
specificity (94.1%) the presence of liver disorders. The high rates
were similar for the different disorders and were independent of
age and sex. Additionally, Medex Test matched the biopsy
pathologic grading of necroinflammation in 78% of patients.
Positive predictive value was not affected by age and sex and was
better for higher degree of necroinflammation.
Conclusions: This pilot study demonstrated that Medex Test
detects with high accuracy the presence of liver disorders and the
necroinflammatory grade. This noninvasive, low cost test may
in the future become an important tool in the diagnosis and
management of liver disorders. We believe the further study of
this novel method is warranted.
Received for publication May 2, 2006; accepted August 1, 2006.
From the *Liver Disease Unit, Gastroenterology Institute, Tel-Aviv
Sorasky Medical Center, Israel, Affiliated to the Sackler School of
Medicine, Tel Aviv University, Tel Aviv, Israel; and wMedex Screen,
Ltd, Arad, Israel.
Financial support: Medex Screen Ltd. has provided the tested device
including its software as well as a skilled operator.
Conflict of interests: Yoav Lurie has previously been employed as a
consultant by Medex Screen Ltd. for several months after the
completion of the study. Alex Kanevsky is currently employed by
Medex Screen Ltd.
Reprints: Yoav Lurie, MD, Gastroenterology Institute, Tel Aviv
Sourasky Medical Center, Weizmann 6, Tel Aviv 64239, Israel
(e-mail: dr_lurie@tasmc.health.gov.il).
Copyright r 2007 by Lippincott Williams & Wilkins
700
Key Words: hepatitis C, hepatitis B, nonalcoholic fatty liver,
liver biopsy, complementary medicine, necroinflammation
(J Clin Gastroenterol 2007;41:700–705)
L iver diseases affect billions worldwide and are asso-
ciated with significant morbidity and mortality as well
as high costs on medical expenditure and work loss.1–6
Moreover, the most common liver diseases, namely
hepatitis B, hepatitis C, and Nonalcoholic Fatty Liver
Degeneration (NAFLD), are frequently asymptomatic
until late in the disease course and are thus under-
diagnosed.2,4,6
Early identification may allow affected individuals
to make valuable lifestyle modifications1,7–9 as well as
consider treatment. Effective treatment modalities are
now available and were found to be cost-effective when
initiated before the onset of cirrhosis and liver failure,10,11
favoring early diagnosis in the asymptomatic phase.
Moreover, from the public health standpoint, identifica-
tion of asymptomatic carriers of hepatitis B and C viruses
(HBV and HCV) may help limit the spread of these
agents, currently the most frequent blood-borne agents in
the United States.1,12
Available diagnostic methods are costly and are
hampered by changing or normal levels (serologic
tests and liver enzymes levels) in different disease
stages.4,5,7,13,14 Additionally, decisions regarding treat-
ment initiation are based on the level of disease
progression. Although various other modalities have
been developed, liver biopsy remains the gold standard
for evaluating liver disease progression. However, this
technique is associated with high cost, significant dis-
comfort and potential life threatening complications.15
Thus a search is warranted for novel diagnostic methods
and additional techniques for the evaluation of liver
disease progression.
As complementary medicine is gaining momentum
with an increase in the proportion of the population
seeking nonconventional therapies,16 new diagnostic
techniques are also being developed. One of these
techniques, which has gained popularity in various
settings throughout the world, is based on a branch of
complementary medicine: neuroreflexology. It is based
on the measurement of the skin electrical impedance
of predetermined areas on the hands and feet (Fig. 1).
J Clin Gastroenterol  Volume 41, Number 7, August 2007
J Clin Gastroenterol  Volume 41, Number 7, August 2007
FIGURE 1. Dermal-visceral zones tested with the ‘‘Medex Test.’’
The rationale is that each internal organ has correspond-
ing representative zones on the skin, the physical
parameters of which are in correspondence with the
condition of the represented organs.
This method, sponsored by various commercial
companies, is considered as ‘‘complementary’’ medicine,
and has seldom been the subject of conventional scientific
study.17 The objectives of the present study are to
determine the effectiveness of this diagnostic test,
specifically the Medex device (Medex Screen Ltd.), in
diagnosing liver disease caused by hepatitis B, C, and
NAFLD and to determine the degree of liver disease
progression.
METHODS
Study Design
The study was conducted in the liver disease clinic at
the Tel-Aviv Sorasky Medical Center, Israel, during 2002,
in 2 parts:
Part 1: The first part of the study was fashioned as
a blinded case control study aimed at comparing the
efficacy of the ‘‘Medex Test’’ in detecting liver disease
with conventional methods. First demographic data and
clinical history were recorded. Additionally, subjects
completed a questionnaire including past medical history,
intravenous drug and alcohol use, prior blood products
treatment and medication use. Patients and healthy
volunteers subsequently underwent a Medex Test by
one of 2 blinded operators. All subjects were evaluated by
a hepatologist who was blinded to the Medex Test results.
Diagnosis was verified and additional liver diseases were
excluded. Tests preformed within 3 months of the Medex
Test were considered current and additional tests were
completed as needed.
Part 2: The second part of the study was also
fashioned as a blinded case-control study, and compared
the degree of necroinflammation measured by the Medex
Test with biopsy results. The grading of liver necroin-
flammation in the biopsies (expressed as histologic grade,
on a scale of 0-4 according to Batts and Ludwig18) was
compared with the Medex Test grading (also expressed on
a scale of 0-4). We also recorded the fibrosis stage
by using the Batts & Ludwig scale for fibrosis.18 Three
patients had a fibrosis stage results that were between 2
stages (eg, 2 to 3) and for the purpose of statistical
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‘‘Medex Test’’ for the Diagnosis of Liver Disease
analysis was considered as the mean of the 2 (eg, 2 to 3
was considered as 2.5).
Study Population
Part 1
Patients treated at the liver disease unit for HBV
and HCV infection and NAFLD were recruited as well
as healthy volunteers. Participation in the study was
proposed to all patients during follow-up outpatient visits
during the recruitment phase (January to April, 2002).
Healthy volunteers were recruited from hospital person-
nel and patient’s chaperons. Patients and healthy controls
were 18 years or older.
Inclusion Criteria—Patients
Chronic hepatitis C was defined as: positive HCV
antibody by a third generation enzyme-linked immuno-
sorbent assay and a positive HCV ribonucleic acid by a
commercial Roche polymerase chain reaction assay with
a sensitivity at least 50 IU/mL.
Chronic hepatitis B was defined as: (1) Positive
HbsAg and HbcAbIgG by a standard commercial kit, (2)
Compatible liver biopsy (optional), (3) Elevated alanine
aminotransferase, if liver biopsy is not available.
NAFLD was defined as: (1) Imaging findings
(abdominal ultra sound and/or computed tomography
and/or magnetic resonance imaging) compatible with
a diagnosis of NAFLD.2,19–21 (2) If NAFLD is not
definitely diagnosed by imaging, then a compatible liver
biopsy is mandatory.
Exclusion Criteria—Patients
Patients were excluded if they had any single
criterion of the criteria detailed below.
1. Amputees
2. Pregnant women
3. Local skin damage in zone of measurement
4. Radiation or chemotherapy during the last 6 months
5. Hepatic failure (Child’s score B and higher)
6. Transplantation candidates or recipients
7. HIV positive by history
8. A diagnosed hepatocellular carcinoma
9. Exclusion of other causes of liver dysfunction includ-
ing alcohol-induced hepatitis, autoimmune hepatitis,
cholestatic disease, Wilsons disease and hemochroma-
tosis by history and laboratory evaluation. In each
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Lurie et al
subgroup, the 2 other etiologies were also excluded (eg,
in HCV patients, HBV and NAFLD were excluded).
Exclusion Criteria: Healthy Volunteers
1. Chronic or previous liver disease by history
2. Abnormal liver function tests by history
3. Injecting drug use
4. Previous treatment with blood products
5. Chronic medical illnesses (eg, diabetes, renal failure,
congestive heart failure, ischemic heart disease) or
chronic medical treatment
6. HIV positive by history
Part 2
In the second part of the study treatment naive
patients with chronic HCV infection and a current biopsy
were included. The same exclusion and inclusion criteria
as in part 1 for HCV patients were used in the second
part. The study population in the 2 parts did not include
the same patients.
Medex Test
In this study we have evaluated a device developed
by Medex Screen Ltd. (Arad, Israel). It consists of a
handheld, pressure operated, electrode and an additional
electrode held by the patient in the opposite hand (Fig. 2).
Through the electrode a small, unfelt, electrical current is
applied to the defined skin areas called the dermal-visceral
FIGURE 2. ‘‘Medex Test’’ device.
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J Clin Gastroenterol  Volume 41, Number 7, August 2007
FIGURE 3. Examples of output graphs of the ‘‘Medex Test.’’
0, No apperent liver disease; 1, Liver disease with grade 1
necroinflammation; 2, Liver disease with grade 2 necroin-
flammation; 3, Liver disease with grade 3 necroinflammation;
4, Liver disease with grade 4 necroinflammation.
zones. The device measures the skin impedances in these
areas (in kO), which are then processed by the device
software (patent number US 10/210,223 ‘‘Non-invasive
method for internal diseases’ diagnosis’’). Before testing,
the skin is cleaned with 70% ethyl alcohol solution to
avoid possible effects of sebum or humidity on the skin.
Measurements are conducted using the skin electrode on
24 predetermined zones on the hands and feet. The
measurements are repeated twice. Between the 2 measure-
ments standard transcutaneous electrical stimulation
of the specific skin areas is performed (1 min, 100 Hz,
25 mA). Subsequently, the measurements are processed
by the device software. The normal value range is created
by incorporating the patient’s measurements into a preset
algorithm. Deviations from the normal range are
recorded and studied (Fig. 3).
Safety Considerations
The electrical measurements are performed with an
electrical current of up to 20 mA (voltage of 5 V) lasting
approximately 0.5 seconds. This low electric current is
considered very safe and is not associated with skin or
any other damage.
Ethical Considerations
The study was approved by the hospital’s Helsinki
ethical committee for clinical investigations. All patients
provided written informed consent before entering
the study.
Statistical Analysis
Statistical analysis was conducted using the SPSS
for Windows 10.0 program. The Medex Test diagnosis
was statistically compared with the results obtained from
the conventional diagnostic methods. The statistical
analysis estimated agreement between the Medex Test
diagnosis and the results of the conventional diagnostic
examinations. A standard measure of agreement (Cohen
k) between the 2 variables was estimated. In addition, all
measures of agreement (sensitivity, specificity, positive,
and negative predictive values) for the Medex Test
diagnosis were calculated using the conventional
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J Clin Gastroenterol  Volume 41, Number 7, August 2007
TABLE 1. Baseline Characteristics of Patients and Controls in Part 1
No. Patients
Healthy volunteers 85
Liver disease patients 113
HCV 91
NAFLD 12
HBV 10
Liver biopsy group 60
diagnosis as the gold standard. P values <0.01 were
considered significant.
To evaluate whether there is a covariate effect in
the accuracy of the test (sex, age, and time since biopsy) a
multivariate logistic regression was performed.
To achieve a significance level of 95%, a sample size
of 200 valuable subjects will be sufficient for estimation of
k between 90% and 100%.
RESULTS
A total of 113 patients with liver disease and 85
volunteers were evaluated during the study. Cases and
controls were age matched (P value for difference NS),
with an average age of 47 years in cases and 46 years
for control (range 21 to 75 for cases and 22 to 76 for
controls). Cases and control did not match by sex,
(P = 0.004) with females comprising 68.2% of health
volunteers and 47.8% of patients with liver disease. The
most common diagnosis was HCV infection with 91
patients, followed by NAFLD with 12 patients and 10
with HBV infection. Basic demographic characteristics
are presented in Table 1.
In the first part of the study, the Medex Test
correctly identified 96/113 of cases and 80/85 of controls.
The sensitivity of the method was 85 ± 7% (sensitiv-
ity ± 95% confidence interval), and the specificity was
94.1 ± 5% (specificity ± 95% confidence interval). Posi-
tive and negative predictive values were 95% and 82.5%,
respectively. There was a statistically significant agree-
ment between the results of the Medex Test and the
clinical diagnosis k = 0.777, P<0.001.
A multivariate logistic regression was performed to
evaluate whether the accuracy of the test in predicting
liver disease depends on sex or age. No significant
interaction was found between sex or age and Medex
Test in the prediction of disease, z = 0.157, P = 0.692 and
z = 0.248, P = 0.957 (for sex and age, respectively).
The size of the sample did not afford statistical
significance for a subgroup analysis evaluating accuracy
of prediction for specific disease groups (HCV, HBV,
NAFLD). Sensitivity was high regardless of the liver
disease with a rate of 100% and 92.5% for HBV and
NAFLD, respectively, and a slightly lower rate of 82.5%
for HCV infection.
In the second part of the study, 60 treatment naive
chronic HCV patients with a current biopsy underwent a
Medex Test (demographic characteristics—Table 1). The
Medex Test was conducted in average 6.3 months after
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‘‘Medex Test’’ for the Diagnosis of Liver Disease
Sex Female (Male) Age Mean (Range)
58 (27) 46 (22-76)
54 (59) 47 (21-75)
45 (46) 47 (21-71)
7 (5) 57 (36-69)
2 (8) 39 (23-53)
30 (30) 40 (18-67)
the biopsy (range 1 to 23 mo). The necroinflammatory
grade in the biopsies was on average 2.05 with a median
of 2. The Medex grading of necroinflammation matched
the pathologic score in 47 cases (78%). In 7 cases there
was a 1 point difference and in 6 cases a 2 point difference
between the Medex Test grade and the pathologic
biopsy-based grade. Rates underestimation was some-
what higher.
Statistical analysis demonstrated that agreement,
presented by k, is significant with a k value of k = 0.704,
P<0.001. To evaluate the effect of the covariates (sex,
age, severity, and time between tests) on the accuracy of
the test, due to the small number of degrees of freedom,
the results of both tests, Medex Test and Biopsy grades,
we recoded as 0, 1, 2 = low and 3, 4 = high. The k value
slightly improved k = 0.772, P<0.001. When values of
both biopsy grade and Medex Test results were recoded
as (1, 2 = low and 3, 4 = high) the k value was k = 0.764,
P<0.001.
For high values (3, 4), corresponding with greater
severity, the positive predictive value of the test was
100%. For low values (1, 2) positive predictive value is
84.6%. This difference was statistically significant
(P<0.05). Additionally, we found that the accuracy of
the Medex Test was not affected by sex or age (P = 0.515
and 1, respectively) nor was it affected by the time lag
between the biopsy and the Medex Test (P = 1). Finally,
as expected, Medex Test did not accurately detect the
degree of fibrosis with a high rate of false positive results.
DISCUSSION
Current diagnosis of hepatic disease is a complex
and often costly process. Liver enzymes tests are often
negative in the presence of significant disease,7,22–24 or
may be persistently elevated in the absence of an
identifiable pathology.25,26 Serologic tests may not
diagnose occult disease and may fail to distinguish
between past and active disorders.13,27,28 Moreover, even
liver biopsy, an invasive costly technique which is
considered the ‘‘gold standard,’’ is subject to sampling
and interpretation errors29–32 and its use is controversial
in many clinical scenarios.33–36
This has brought about a surge of novel diagnostic
tests using new37–39 and adapted40–44 modalities in the
understanding that no single test will replace its pre-
decessors. Instead, new measures will be incorporated in
existing diagnostic algorithms to enhance their cost-
effectiveness.
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Lurie et al
In this study we have evaluated the efficacy of
a novel test—Medex Test which is a development of a
practiced branch of complementary medicine called
neuroreflexology. This diagnostic test is intended to
detect the presence of liver disorders and to assess their
severity although it does not define the exact diagnosis.
It has several advantages, namely, it is noninvasive,
safe, relatively inexpensive, and is preformed in a short
time.
Our first main finding is that the Medex Test
detected, with high sensitivity and specificity, the presence
of liver disease. High sensitivity was maintained for
different liver diseases (HCV, HBV, and NAFLD) and
regardless of patients’ age and sex.
A second important finding is that the Medex Test
has graded the degree of necroinflammation with 78%
accuracy when compared with liver biopsy.
Although unable to provide data regarding to liver
fibrosis, Medex Test detected the level of inflammation
noninvasively in rates which are comparable with liver
biopsy. Necroinflammatory grade may be valuable as a
possible correlate with long-term outcome and in certain
clinical considerations such as treatment initiation in
advanced liver disease.45–48
Study limitations include the small sample size for
hepatitis B and nonalcoholic fatty liver, which limits the
statistical power of subgroup, by diagnosis analysis.
Sample size was calculated to afford statistical power to
the detection of disease as such (without giving the
specific diagnosis), thus in future studies, an evaluation by
specific diagnosis (eg, HCV, HBV etc.) should be
conducted. Additionally, cases and controls were not
well matched by sex. Finally, the control group under-
went a comprehensive clinical evaluation yet only a
limited laboratory evaluation. Thus, there may have been
more undiagnosed liver disease in the control group
which may bias the results. Nevertheless, we believe that
stringent exclusion criteria applied, excluding all high risk
groups, may have minimized this possible bias.
In conclusion, the evaluated diagnostic test has a
high accuracy rate both for detecting the presence of liver
disorders and for determining its severity. Further study
is warranted to verify these results in larger cohorts and to
determine the possible role of Medex Test in existing
diagnostic algorithms. Additional studies may also
further define the optimal thresholds for different clinical
settings, allowing increased sensitivity when screening, or
increased specificity for follow-up purposes.
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