What is the probability of false positive and false negative results from the serological tests?**
Vijay Kumar, M.D., Research Associate Professor
at the University of Buffalo and President and Director of IMMCO
Diagnostics: The three serological tests that are used for
diagnosing celiac disease are:
- Anti-endomysial
antibody (EMA)
- Anti-reticulin
antibody (ARA)
- Anti-gliadin
antibody (AGA)
Each of these
three tests provide a certain degree of reliability for diagnosing
CD. Of these, endomysial antibody is the most specific test. The following
table is taken from our studies (Lerner, Kumar, Iancu, Immunological
diagnosis of childhood coeliac disease: comparison between antigliadin,
antireticulin and antiendomysial antibodies).
| |
%
of Sensitivity |
%
of Specificity |
Predictive
Value % Pos |
Predictive
Value % Neg |
| EMA |
97% |
98% |
97% |
98% |
| ARA |
65% |
100% |
100% |
72% |
| IgG AGA |
88% |
92% |
88% |
92% |
| IgA AGA |
52% |
94% |
87% |
74% |
The following
definitions related to sensitivity, specificity, positive and negative
predictive values may help:
Sensitivity is
the probability of a positive test result in a patient with disease.
Specificity is the probability of negative test result in a patient
without disease. Positive predictive value is the probability of disease
in a patient with positive test result. Negative predictive value
is the probability of no disease in a patient with negative test result.
Karoly Horvath,
M.D., Ph.D., Associate Professor of Pediatrics; Director, Peds GI
& Nutrition Laboratory; University of Maryland at Baltimore:
The summary below shows the results of the main serological tests
based on several publications including 388 patients with CD, and
771 healthy subjects.
SENSITIVITY-
the proportion of subjects with the disease who have a positive test.
It indicates how good a test is at identifying the diseased:
| |
Percentage
of - IgA AGA |
Percentage
of - IgG AGA |
Percentage
of - IgA EMA |
| Average |
78% |
79% |
97% |
| Range |
46-100% |
57-94% |
89-100% |
SPECIFICITY-
the proportion of subjects without the disease who have a negative
test. It indicates how good a test is at identifying the non-diseased:
| |
Percentage
of - IgA AGA |
Percentage
of - IgG AGA |
Percentage
of - IgA EMA |
| Average |
92% |
84% |
98.5% |
| Range |
84-100% |
52-98% |
97-100% |
POSITIVE
PREDICTIVE VALUE- the probability that a person with positive results
actually has the disease:
| |
Percentage
of - IgA AGA |
Percentage
of - IgG AGA |
Percentage
of - IgA EMA |
| Average |
72% |
57% |
92% |
| Range |
45-100% |
42-76% |
91-94% |
NEGATIVE
PREDICTIVE VALUE- the probability that a person with negative results
does not have the disease:
| |
Percentage
of - IgA AGA |
Percentage
of - IgG AGA |
Percentage
of - IgA EMA |
| Average |
94% |
94% |
100% |
| Range |
89-100% |
83-99% |
100% |
References:
McMillan SA, Haughton DJ, Biggart JD, Edgar JD, Porter KG, McNeill
TA. Predictive value for coeliac disease of antibodies to gliadin,
endomysium, and jejunum in patients attending for jejunal biopsy.
Brit Med J 1991;303:1163-1165
Ferreira M, Lloyd Davies S, Butler M, Scott D, Clark M, Kumar P.
Endomysial antibody: is it the best screening test for coeliac
disease? Gut 1992;33:1633-1637.
Khoshoo V, Bhan MK, Puri S, Jain R, Jayashree S, Bhatnagar S, Kumar
R, Stintzing G. Serum antigliadin antibody profile in childhood
protracted diarrhea due to coeliac disease and other causes
in a developing country. Scand J Gastroenterol 1989;24:1212-1216.
Chan KN, Phillips AD, Mirakian R, Walker-Smith JA. Endomysial antibody
screening in children. J Pediatr Gastroenterol Nutr 1994;18:316-320.
Bode S, Weile B, Krasilnikoff PA, Gdmand-Hyer E. The diagnostic
value of the gliadin antibody testing celiac disease in children:
a prospective study. J Pediatr Gastroenterol Nutr 1993;17:260-264.
Calabuig M, Torregosa R, Polo P, Tom s C, Alvarez V, Garcia-Vila
A, Brines J, Vilar P, Farr C, Varea V. Serological markers and
celiac disease: a new diagnostic approach ? J Pediatr Gastroenterol
Nutr 1990;10:435-442.