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Clinical and Diagnostic Laboratory Immunology, April 2005, p. 491-496, Vol. 12, No. 4
1071-412X/05/$08.00+0     doi:10.1128/CDLI.12.4.491-496.2005
Copyright © 2005, American Society for Microbiology. All Rights Reserved.

Prospective Evaluation of a Whole-Blood Test Using Mycobacterium tuberculosis-Specific Antigens ESAT-6 and CFP-10 for Diagnosis of Active Tuberculosis

Pernille Ravn,1* Martin E. Munk,2,{dagger} Åse B. Andersen,3 Bettina Lundgren,4 Jens D. Lundgren,5 Lars N. Nielsen,1 Axel Kok-Jensen,6 Peter Andersen,2 and Karin Weldingh2

Department of Infectious Diseases, Hvidovre University Hospital, Kettegårds Alle 30, 2650 Hvidovre, Denmark,1 Department of Infectious Disease Immunology, Staten Serum Institute, Artillerivej 5, 2300 Copenhagen S, Denmark,2 Department of Infectious Diseases, Rigshospitalet, Blegdamsvej 3, 2000 Copenhagen Ø, Denmark,3 Department of Microbiology, Hvidovre Hospital, Kettegårds Alle 30, 2650 Hvidovre, Denmark,4 Copenhagen HIV Programme, Hvidovre University Hospital, Copenhagen, Denmark,5 Department of Pulmonary Diseases, Gentofte Hospital, Niels Andersensvej, 2300 Gentofte, Denmark6

Received 26 October 2004/ Returned for modification 7 January 2005/ Accepted 22 February 2005

A new immunodiagnostic test based on the Mycobacterium tuberculosis-specific antigens CFP-10/ESAT-6(QFT-RD1) has been launched as an aid in the diagnosis of latent tuberculosis (TB) infection (LTBI). The aim of this study was to evaluate this test for the diagnosis of active TB. Eighty-two patients with suspicion of TB and 39 healthy BCG-vaccinated persons were enrolled. Forty-eight had active TB, 25 did not, and 9 were excluded. Sensitivity and specificity of the test for active TB were evaluated in a prospective blinded manner in patients suspected of TB. The sensitivity of the QFT-RD1 was 85% (40/48; confidence interval [CI], 75 to 96), and it was higher than the sensitivity of microscopy, 42% (20/48; CI, 27 to 56; P = 0.001), and culture, 59% (27/46; CI, 44 to 73; P = 0.009). Of patients with extrapulmonary TB, 92% (12/13) were QFT-RD1 positive, whereas only 31% (4/13) were positive by microscopy and 42% (5/12) by culture (P < 0.05), and 87% (13/15) of those who were negative by both microscopy and culture were QFT-RD1 positive. By combining microscopy and culture with the QFT-RD1 test, sensitivity increased to 96% (CI, 90 to 102). Ten of 25 (40%) non-TB patients were QFT-RD1 positive, resulting in a specificity of 60%. However, 80% (8/10) of these had risk-factors for TB, indicating latent infection in this group. In healthy controls, only 3% (1/39) were QFT-RD1 positive. In conclusion, the QFT-RD1 test is sensitive for diagnosis of TB, especially in patients with negative microscopy and culture. The accuracy of the QFT-RD1 test will vary with the prevalence of LTBI. We suggest that the QFT-RD1 test could be a very useful supplementary tool for the diagnosis of TB.

* Corresponding author. Mailing address: Department of Infectious Diseases, Hvidovre Hospital, Kettegårds Alle 30, 2650 Hvidovre, Copenhagen, Denmark. Phone: 45 36 32 35 16. Fax: 45 36 17 28 38. E-mail: pravn{at}dadlnet.dk.

{dagger} Present address: Genmab A/S, Toldbodgade 59b, 1253 Copenhagen, Denmark.

Clinical and Diagnostic Laboratory Immunology, April 2005, p. 491-496, Vol. 12, No. 4
1071-412X/05/$08.00+0     doi:10.1128/CDLI.12.4.491-496.2005
Copyright © 2005, American Society for Microbiology. All Rights Reserved.



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