title: Large-scale evaluation of enzyme-linked immunospot assay and skin test for diagnosis of Mycobacterium tuberculosis infection against a gradient of exposure in The Gambia.
abstract: The purified protein derivative (PPD) skin test for Mycobacterium tuberculosis infection lacks specificity. We assessed 2 more specific M. tuberculosis antigens (ESAT-6 and CFP-10) by enzyme-linked immunospot assay (ELISPOT) compared with PPD by ELISPOT and skin test in The Gambia. Of 735 household contacts of 130 sputum smear-positive tuberculosis cases, 476 (65%) tested positive by PPD ELISPOT, 300 (41%) tested positive by PPD skin test, and 218 (30%) tested positive by ESAT-6/CFP-10 ELISPOT. Only 15 (2%) had positive ESAT-6/CFP-10 results and negative PPD results by ELISPOT. With increasing M. tuberculosis exposure, the percentage of subjects who were PPD skin test positive/ESAT-6/CFP-10 ELISPOT negative increased (P<.001), whereas the percentage of subjects who were PPD skin test negative/PPD ELISPOT positive decreased (P=.011). Eighteen (31%) ESAT-6/CFP-10 ELISPOT-positive subjects in the lowest exposure category had negative PPD skin test results. ESAT-6/CFP-10 ELISPOT probably offers increased specificity in the diagnosis of M. tuberculosis infection in this tropical setting of endemicity, at the cost of some sensitivity.
authors.affiliation: Tuberculosis Division, Medical Research Council Laboratories, Banjul, The Gambia. phill@mrc.gm
authors.forename: Philip C
authors.initials: PC
authors.lastname: Hill
authors.forename: Roger H
authors.initials: RH
authors.lastname: Brookes
authors.forename: Annette
authors.initials: A
authors.lastname: Fox
authors.forename: Katherine
authors.initials: K
authors.lastname: Fielding
authors.forename: David J
authors.initials: DJ
authors.lastname: Jeffries
authors.forename: Dolly
authors.initials: D
authors.lastname: Jackson-Sillah
authors.forename: Moses D
authors.initials: MD
authors.lastname: Lugos
authors.forename: Patrick K
authors.initials: PK
authors.lastname: Owiafe
authors.forename: Simon A
authors.initials: SA
authors.lastname: Donkor
authors.forename: Abdulrahman S
authors.initials: AS
authors.lastname: Hammond
authors.forename: Jacob K
authors.initials: JK
authors.lastname: Otu
authors.forename: Tumani
authors.initials: T
authors.lastname: Corrah
authors.forename: Richard A
authors.initials: RA
authors.lastname: Adegbola
authors.forename: Keith P W J
authors.initials: KP
authors.lastname: McAdam
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000942:Antigens, Bacterial / Q000032:analysis*; D001426:Bacterial Proteins / Q000032:analysis*; D002648:Child; D002675:Child, Preschool; D004797:Enzyme-Linked Immunosorbent Assay / Q000379:methods*; D005260:Female; D005714:Gambia; D006801:Humans; D007223:Infant; D008297:Male; D008875:Middle Aged; D009169:Mycobacterium tuberculosis / Q000302:isolation & purification*; D012680:Sensitivity and Specificity; D012882:Skin Tests / Q000379:methods*; D014373:Tuberculin / Q000032:analysis
chemical_list: D000942:Antigens, Bacterial; D001426:Bacterial Proteins; C117940:CFP-10 protein, Mycobacterium tuberculosis; C093276:ESAT-6 protein, Mycobacterium tuberculosis; D014373:Tuberculin