AAAAI: Ready-To-Use Test Increases Accuracy in Diagnosis of Cow's Milk Allergy
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AAAAI: Ready-To-Use Test Increases Accuracy in Diagnosis of Cow's Milk Allergy

By Paula Moyer

SAN ANTONIO, TX -- March 23, 2005 -- A new ready-to-use test for cow's milk allergy in young children is more accurate than conventional tests used in physicians' offices, according to findings presented here March 20th at the 61st annual meeting of the American Academy of Allergy, Asthma, and Immunology.

"This test has good sensitivity and specificity with no adverse effects," said principal investigator Christoph DuPont, MD, consulting allergist, department of paediatrics and neonatology, Hôpital Cochin-Saint Vincent-de-Paul, Paris, France.

The Diallertest consists of a patch that is applied to the patient's skin for 48 hours and later removed by the parent; the results are readable 72 hours after application. Company literature states that the new test has greater accuracy because it maintains protein allergens in their native state without using preservatives or excipients. The manufacturers intend the test to also be easier to use than the patch tests typically used to test for paediatric cow's milk allergy.

Dr. DuPont and colleagues conducted a prospective study to compare the Diallertest against a conventional patch test for cow's milk allergy. The study involved 49 children who were an average of 34.3 months old. All subjects had been diagnosed with cow's milk allergy. Their key symptom was atopic dermatitis in 10.2%, gastrointestinal disturbances in 40.8%, and both in 49%.

All children were tested using both tests and test results were read for each subject 72 hours after application. The children then were placed on a milk elimination diet for 4 to 6 weeks, after which they underwent an open oral food challenge test.

The investigators documented a positive result in 44.8% of the investigative tests compared to 26.5% of the control tests. Neither test caused adverse effects. The test results were concordant in 67.3% of cases.

Of the 41 food challenges, 60.9% were positive; eight patients were lost to follow-up.

The investigative test's sensitivity was 76% (95% confidence interval 59.2-92.7) compared to 44% for the control test (24.5-63.4, P =.02). The specificity was 93.8% (81.9-100) for each.

Positive predictive value was 95% (85.4-100) for the Diallertest, with one false positive result, compared to 91.7% (76-100) for the control, which also had one false positive. Negative predictive value was 71.4% (52-90.7) for the investigative test, which had six false negatives, compared to 51.7% (33.5-69.8) for the control, which had 14 false negatives.

The overall test accuracy was 82.9% (71.3-94.5) for the investigative test and 63.4% (48.6-78.1) for the control (P <.05).

Based on these findings, Dr. DuPont and colleagues concluded that the new test is not only more convenient but also more accurate.

The study was funded by DBV technologies of Boulogne, France, which manufactures Diallertest.

[Presentation title: Usefulness and Safety of a Read-to-Use Atopy Patch Test (APT) (Diallertest®) Versus a Reference Test (Finn Chamber®) During Cow's Milk Allergy in Children. Abstract 247]

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