title: Quantitation of human immunodeficiency virus type 1 viral load in plasma using reverse transcriptase activity assay at a district hospital laboratory in Botswana: a decentralization pilot study.
abstract: Roche COBAS Amplicor monitor version 1.5 assay is considered gold standard for viral load monitoring in Botswana. Due to its demand for elaborate infrastructure, viral load testing has been confined to the national HIV reference laboratories. Cavidi ExaVir Load version 2 assay was considered as a potential alternative to decentralize viral load testing to the rural/remote hospital laboratories and thus increase access to therapy. This study compared the performance of ExaVir Load v2 assay at a district hospital laboratory in Serowe and COBAS Amplicor monitor v1.5 assay at the Botswana Harvard HIV Reference Laboratory using quality assessment samples and plasma from HIV-positive individuals. ExaVir Load v2 and COBAS Amplicor monitor v1.5 assays had very good agreement; Kappa statistic 0.951. The COBAS Amplicor monitor v1.5 and ExaVir Load v2 assays detected HIV-1 RNA in 84 and 86 samples but did not detect HIV-1 RNA in 221 and 219 samples, respectively. The two assays detected HIV-1 RNA concordantly in 82 samples and were strongly correlated (r=0.8554, P<0.0001). ExaVir Load v2 assay provided a simple and reliable alternative viral load system that is adaptable to district hospital laboratories. The cost per test is less than RT-PCR. The ExaVir Load v2 systems have since been placed in four more district and primary hospital laboratories.
authors.affiliation: National Health Laboratory, 5353 Church Road, Extension 10, Gaborone, Botswana. mmine@bhp.org.bw
authors.forename: Madisa
authors.initials: M
authors.lastname: Mine
authors.forename: Keabetswe
authors.initials: K
authors.lastname: Bedi
authors.forename: Talkmore
authors.initials: T
authors.lastname: Maruta
authors.forename: Dignity
authors.initials: D
authors.lastname: Madziva
authors.forename: Modiri
authors.initials: M
authors.lastname: Tau
authors.forename: Tatenda
authors.initials: T
authors.lastname: Zana
authors.forename: Tendani
authors.initials: T
authors.lastname: Gaolathe
authors.forename: Sikhulile
authors.initials: S
authors.lastname: Moyo
authors.forename: Khumo
authors.initials: K
authors.lastname: Seipone
authors.forename: Ndwapi
authors.initials: N
authors.lastname: Ndwapi
authors.forename: Max
authors.initials: M
authors.lastname: Essex
authors.forename: Richard
authors.initials: R
authors.lastname: Marlink
mesh_terms: D001902:Botswana; D015658:HIV Infections / Q000097:blood / Q000821:virology*; D054303:HIV Reverse Transcriptase / Q000378:metabolism*; D015497:HIV-1 / Q000201:enzymology* / Q000235:genetics; D006767:Hospitals, District; D006801:Humans; D007755:Laboratories, Hospital; D010865:Pilot Projects; D011057:Politics; D012367:RNA, Viral / Q000302:isolation & purification; D011933:Reagent Kits, Diagnostic; D019562:Viral Load / Q000379:methods*
chemical_list: D012367:RNA, Viral; D011933:Reagent Kits, Diagnostic; C514824:reverse transcriptase, Human immunodeficiency virus 1; D054303:HIV Reverse Transcriptase