BACKGROUND: We developed a simple and inexpensive thin-layer chromatography (TLC) assay for semiquantitative detection of saliva concentrations of nevirapine in resource-limited settings. The method was validated in an African target population. METHODS: Paired plasma and saliva nevirapine concentrations were assayed by high-performance liquid chromatography (HPLC); saliva concentrations of nevirapine were also assayed by TLC. The rate of false-positive results was the proportion of subtherapeutic nevirapine saliva and plasma concentrations determined by HPLC that were judged to be therapeutic in saliva specimens by TLC. The rate of false-negative results was the proportion of therapeutic nevirapine saliva and plasma concentrations determined by HPLC that were judged to be subtherapeutic in saliva specimens by TLC. The extent of agreement in TLC readings between 5 technicians and 2 batches of TLC sheets was evaluated. RESULTS: Twenty-five (9%) of 286 African adults had a subtherapeutic plasma nevirapine concentration. The median ratio of nevirapine concentrations in saliva to those in plasma was 0.51:1. The rate of false-positive results for TLC was 0% (0 of 23 specimens) when TLC results were compared with HPLC results for saliva specimens and 8% (2 of 25 specimens) when TLC results were compared with HPLC results for plasma specimens. The rate of false-negative results for TLC was 1% (3 of 263 specimens) when TLC results were compared with HPLC results for saliva specimens and 1% (3 of 261 specimens) when TLC results were compared with HPLC results for plasma specimens. The extent of agreement of TLC results was substantial for the 5 technicians (Fleiss's kappa = 0.77) and for the 2 batches of sheets (Cohen's kappa = 0.80). CONCLUSIONS: The TLC assay was found to be sensitive, specific, and robust in the detection of subtherapeutic nevirapine concentrations in saliva specimens obtained from African HIV-infected adults. It is an attractive alternative to HPLC for therapeutic drug monitoring of nevirapine in resource-limited settings.
BACKGROUND: We developed a simple and inexpensive thin-layer chromatography (TLC) assay for semiquantitative detection of saliva concentrations of nevirapine in resource-limited settings. The method was validated in an African target population. METHODS: Paired plasma and saliva nevirapine concentrations were assayed by high-performance liquid chromatography (HPLC); saliva concentrations of nevirapine were also assayed by TLC. The rate of false-positive results was the proportion of subtherapeutic nevirapine saliva and plasma concentrations determined by HPLC that were judged to be therapeutic in saliva specimens by TLC. The rate of false-negative results was the proportion of therapeutic nevirapine saliva and plasma concentrations determined by HPLC that were judged to be subtherapeutic in saliva specimens by TLC. The extent of agreement in TLC readings between 5 technicians and 2 batches of TLC sheets was evaluated. RESULTS: Twenty-five (9%) of 286 African adults had a subtherapeutic plasma nevirapine concentration. The median ratio of nevirapine concentrations in saliva to those in plasma was 0.51:1. The rate of false-positive results for TLC was 0% (0 of 23 specimens) when TLC results were compared with HPLC results for saliva specimens and 8% (2 of 25 specimens) when TLC results were compared with HPLC results for plasma specimens. The rate of false-negative results for TLC was 1% (3 of 263 specimens) when TLC results were compared with HPLC results for saliva specimens and 1% (3 of 261 specimens) when TLC results were compared with HPLC results for plasma specimens. The extent of agreement of TLC results was substantial for the 5 technicians (Fleiss's kappa = 0.77) and for the 2 batches of sheets (Cohen's kappa = 0.80). CONCLUSIONS: The TLC assay was found to be sensitive, specific, and robust in the detection of subtherapeutic nevirapine concentrations in saliva specimens obtained from African HIV-infected adults. It is an attractive alternative to HPLC for therapeutic drug monitoring of nevirapine in resource-limited settings.
Authors: Maureen J Kimulwo; Javan Okendo; Rashid A Aman; Bernhards R Ogutu; Gilbert O Kokwaro; Dorothy J Ochieng; Anne W T Muigai; Florence A Oloo; Washingtone Ochieng Journal: PLoS One Date: 2017-02-24 Impact factor: 3.240
Authors: Alper Daskapan; Lusiana R Idrus; Maarten J Postma; Bob Wilffert; Jos G W Kosterink; Ymkje Stienstra; Daniel J Touw; Aase B Andersen; Adrie Bekker; Paolo Denti; Agibothu K Hemanth Kumar; Kidola Jeremiah; Awewura Kwara; Helen McIlleron; Graeme Meintjes; Joep J van Oosterhout; Geetha Ramachandran; Neesha Rockwood; Robert J Wilkinson; Tjip S van der Werf; Jan-Willem C Alffenaar Journal: Clin Pharmacokinet Date: 2019-06 Impact factor: 6.447
Authors: Albert Y Liu; Qiyun Yang; Yong Huang; Peter Bacchetti; Peter L Anderson; Chengshi Jin; Kathy Goggin; Kristefer Stojanovski; Robert Grant; Susan P Buchbinder; Ruth M Greenblatt; Monica Gandhi Journal: PLoS One Date: 2014-01-08 Impact factor: 3.240
Authors: Randy M Stalter; Thomas R Moench; Kathleen M MacQueen; Elizabeth E Tolley; Derek H Owen Journal: J Int AIDS Soc Date: 2016-05-02 Impact factor: 5.396