title: Lateral flow-based antibody testing for Chlamydia trachomatis.
abstract: We describe here a lateral flow-based assay (LFA) for the detection of antibodies against immunodominant antigen Pgp3 from Chlamydia trachomatis, the causative agent of urogenital chlamydia infection and ocular trachoma. Optimal signal detection was achieved when the gold-conjugate and test line contained Pgp3, creating a dual sandwich capture assay. The LFA yielded positive signals with serum and whole blood but not with eluted dried blood spots. For serum, the agreement of the LFA with the non-reference multiplex assay was 96%, the specificity using nonendemic pediatric sera was 100%, and the inter-rater agreement was κ=0.961. For whole blood, the agreement of LFA with multiplex was 81.5%, the specificity was 100%, and the inter-rater agreement was κ=0.940. The LFA was tested in a field environment and yielded similar results to those from laboratory-based testing. These data show the successful development of a lateral flow assay for detection of antibodies against Pgp3 with reliable use in field settings, which would make antibody-based testing for trachoma surveillance highly practical, especially after cessation of trachoma elimination programs.
authors.affiliation: IHRC, Inc., Centers for Disease Control and Prevention, USA.
authors.forename: Sarah
authors.initials: S
authors.lastname: Gwyn
authors.affiliation: IHRC, Inc., Centers for Disease Control and Prevention, USA.
authors.forename: Alexandria
authors.initials: A
authors.lastname: Mitchell
authors.affiliation: UCSF Benioff Children's Hospital Oakland, Children's Hospital Oakland Research Institute, Oakland, CA, USA; University of California at San Francisco and Berkeley Graduate Program in Bioengineering, Berkeley, CA, USA.
authors.forename: Deborah
authors.initials: D
authors.lastname: Dean
authors.affiliation: Kongwa Trachoma Project, Kongwa, Tanzania.
authors.forename: Harran
authors.initials: H
authors.lastname: Mkocha
authors.affiliation: Division of Parasitic Diseases and Malaria, Centers for Disease Control and Prevention, Atlanta, GA, USA.
authors.forename: Sukwan
authors.initials: S
authors.lastname: Handali
authors.affiliation: Division of Parasitic Diseases and Malaria, Centers for Disease Control and Prevention, Atlanta, GA, USA. Electronic address: hzx3@cdc.gov.
authors.forename: Diana L
authors.initials: DL
authors.lastname: Martin
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000907:Antibodies, Bacterial / Q000097:blood* / Q000276:immunology; D000942:Antigens, Bacterial / Q000276:immunology*; D001426:Bacterial Proteins / Q000276:immunology*; D002648:Child; D002675:Child, Preschool; D002690:Chlamydia Infections / Q000175:diagnosis* / Q000276:immunology; D002692:Chlamydia trachomatis / Q000737:chemistry* / Q000276:immunology; D006801:Humans; D007118:Immunoassay / Q000379:methods*; D007223:Infant; D008875:Middle Aged; D012680:Sensitivity and Specificity; D014141:Trachoma / Q000175:diagnosis / Q000276:immunology; D055815:Young Adult
chemical_list: D000907:Antibodies, Bacterial; D000942:Antigens, Bacterial; D001426:Bacterial Proteins; C082169:pgp3 protein, Chlamydia
keywords: Antibody; Chlamydia trachomatis; Lateral flow; Serosurveillance; Trachoma