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Clinical Chemistry and Laboratory Medicine (CCLM)

Published in Association with the European Federation of Clinical Chemistry and Laboratory Medicine (EFLM)

Editor-in-Chief: Plebani, Mario

Ed. by Gillery, Philippe / Lackner, Karl J. / Lippi, Giuseppe / Melichar, Bohuslav / Schlattmann, Peter / Tate, Jillian R. / Tsongalis, Gregory J.

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Good performance of an immunoassay based method for nevirapine measurements in human breast milk

1 / Zahra Persson Theilgaard1 / Mercy Chiduo2 / Court Pedersen3 / Jan Gerstoft1 / Terese Lea Katzenstein1

1Department of Infectious Diseases, Rigshospitalet, Copenhagen, Denmark

2National Institute of Medical Research, Tanga, Tanzania

3Department of Infectious Diseases, University of Southern Denmark, Odense, Denmark

Corresponding author: Kirsten Salado-Rasmussen, MD, Classensgade 67, 6.tv, 2100 Copenhagen, Denmark Phone: +45 22816717

Citation Information: Clinical Chemistry and Laboratory Medicine. Volume 49, Issue 7, Pages 1171–1175, ISSN (Online) 1437-4331, ISSN (Print) 1434-6621, DOI: 10.1515/CCLM.2011.184, April 2011

Publication History

Received:
2010-11-08
Accepted:
2011-02-06
Published Online:
2011-04-20

Abstract

Background: Understanding the distribution of antiretro-virals in breastfeeding HIV-positive mothers is essential, both for prevention of mother-to-child HIV transmission and for research on the development of drug resistance. The ARK nevirapine (NVP)-test is an immunoassay method for nevirapine measurements, developed and validated for plasma use. In this study, the ARK NVP-test was evaluated for measurement of nevirapine concentrations in breast milk. High performance liquid chromatography (HPLC) is the method currently used to determine nevirapine in breast milk. This method, however, requires complicated extraction techniques. The ARK method employs an immunoassay technology and requires a small sample volume (40 μL) and no pre-treatment of the samples.

Methods: Commercial enzyme and antibody were used and calibration standards and quality controls were prepared from pooled breast milk from HIV-uninfected women. Clinical samples from HIV-infected women receiving a single-dose of nevirapine were analyzed.

Results: Precision and accuracy were evaluated with two concentrations of quality control materials analyzed in three replicates on four different days and was <4%, and between 96.5% and 104.6%, respectively. Clinical samples were analyzed and CVs ranged from 0.0% to 11.1%. The median nevirapine concentration in breast milk 1 week post-partum was 0.29 μg/mL (range 0.11–0.90 μg/mL) in women treated with a single-dose of nevirapine.

Conclusions: The ease of use and small sample volume makes the ARK assay an attractive alternative to HPLC analyses for determinations of nevirapine concentrations in breast milk.

Keywords: antiretroviral drug; breast milk; immunoassay; nevirapine

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