Jump to ContentJump to Main Navigation
Show Summary Details

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 / Payne, Deborah A. / Schlattmann, Peter / Tate, Jillian R.

12 Issues per year

IMPACT FACTOR increased in 2015: 3.017
Rank 5 out of 30 in category Medical Laboratory Technology in the 2014 Thomson Reuters Journal Citation Report/Science Edition

SCImago Journal Rank (SJR) 2015: 0.873
Source Normalized Impact per Paper (SNIP) 2015: 0.982
Impact per Publication (IPP) 2015: 2.238

See all formats and pricing
Volume 49, Issue 7 (Jul 2011)


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

Kirsten Salado-Rasmussen
  • Department of Infectious Diseases, Rigshospitalet, Copenhagen, Denmark
  • Email:
/ Zahra Persson Theilgaard
  • Department of Infectious Diseases, Rigshospitalet, Copenhagen, Denmark
/ Mercy Chiduo
  • National Institute of Medical Research, Tanga, Tanzania
/ Court Pedersen
  • Department of Infectious Diseases, University of Southern Denmark, Odense, Denmark
/ Jan Gerstoft
  • Department of Infectious Diseases, Rigshospitalet, Copenhagen, Denmark
/ Terese Lea Katzenstein
  • Department of Infectious Diseases, Rigshospitalet, Copenhagen, Denmark
Published Online: 2011-04-20 | DOI: https://doi.org/10.1515/CCLM.2011.184


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

About the article

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

Received: 2010-11-08

Accepted: 2011-02-06

Published Online: 2011-04-20

Published in Print: 2011-07-01

Citation Information: Clinical Chemistry and Laboratory Medicine, ISSN (Online) 1437-4331, ISSN (Print) 1434-6621, DOI: https://doi.org/10.1515/CCLM.2011.184. Export Citation

Citing Articles

Here you can find all Crossref-listed publications in which this article is cited. If you would like to receive automatic email messages as soon as this article is cited in other publications, simply activate the “Citation Alert” on the top of this page.

Robin DiFrancesco, Getrude Maduke, Rutva Patel, Charlene R Taylor, and Gene D Morse
Bioanalysis, 2013, Volume 5, Number 3, Page 351

Comments (0)

Please log in or register to comment.
Log in