Retrospective Study
Copyright ©The Author(s) 2016. Published by Baishideng Publishing Group Inc. All rights reserved.
World J Virol. May 12, 2016; 5(2): 73-81
Published online May 12, 2016. doi: 10.5501/wjv.v5.i2.73
Active tracking of rejected dried blood samples in a large program in Nigeria
Auchi Inalegwu, Sunny Phillips, Rawlings Datir, Christopher Chime, Petronilla Ozumba, Samuel Peters, Obinna Ogbanufe, Charles Mensah, Alash’Le Abimiku, Patrick Dakum, Nicaise Ndembi
Auchi Inalegwu, Sunny Phillips, Rawlings Datir, Christopher Chime, Petronilla Ozumba, Samuel Peters, Charles Mensah, Alash’Le Abimiku, Patrick Dakum, Nicaise Ndembi, Institute of Human Virology, Abuja 900246, Federal Capital Territory, Nigeria
Obinna Ogbanufe, US Centers for Disease Control and Prevention, Embassy of the United States of America, Abuja 1076, Nigeria
Alash’Le Abimiku, Patrick Dakum, Institute of Human Virology, University of Maryland School of Medicine, Baltimore, MD 21201, United States
Author contributions: Inalegwu A, Phillips S and Ndembi N designed and performed the research and wrote the first draft paper; Ndembi N supervised the research work; Datir R, Chime C, Ozumba P, Peters S, Ogbanufe O, Mensah C, Abimiku A and Dakum P revised the manuscript and contributed to the analysis.
Supported by The President’s Emergency Plan for AIDS Relief through cooperative agreement (5U2GGH000925-03) from HHS/Centers for Disease Control and Prevention (CDC), Global AIDS Program. The findings and conclusions in this report are those of the author(s) and do not necessarily represent the official position of the Centers for Disease Control and Prevention.
Institutional review board statement: The study was approved by the Institutional Review Board and Ethics Committee of the Institute of Human Virology, Nigeria and the National Human Research and Ethics Committee (NHREC Approval#NHREC/01/01/2007-15/08/2015). No patient identifying information was retained. Data analysis was unlinked and anonymous. With delinking of patient identifiers and confidentiality safeguards, the benefits of improved health care quality outweigh the minimal risks.
Informed consent statement: Patients were not required to give informed consent to the study because the analysis used secondary de-identified/anonymous clinical data that were obtained after each patient agreed to be enrolled in our treatment program.
Conflict-of-interest statement: The authors declare that they have no conflict of interest or no financial relationships to disclose.
Data sharing statement: No additional available data are available.
Open-Access: This article is an open-access article which was selected by an in-house editor and fully peer-reviewed by external reviewers. It is distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See:
Correspondence to: Nicaise Ndembi, PhD, Institute of Human Virology, Pent House, Maina Court, 252 Herbert Macaulay Way, Central Business District, PO Box 9396 Garki, Abuja 900246, Federal Capital Territory, Nigeria.
Telephone: +234-703-4431136
Received: January 8, 2016
Peer-review started: January 12, 2016
First decision: February 2, 2016
Revised: March 14, 2016
Accepted: April 5, 2016
Article in press: April 6, 2016
Published online: May 12, 2016

AIM: To study the impact of rejection at different levels of health care by retrospectively reviewing records of dried blood spot samples received at the molecular laboratory for human immunodeficiency virus (HIV) early infant diagnosis (EID) between January 2008 and December 2012.

METHODS: The specimen rejection rate, reasons for rejection and the impact of rejection at different levels of health care was examined. The extracted data were cleaned and checked for consistency and then de-duplicated using the unique patient and clinic identifiers. The cleaned data were ciphered and exported to SPSS version 19 (SPSS 2010 IBM Corp, New York, United States) for statistical analyses.

RESULTS: Sample rejection rate of 2.4% (n = 786/32552) and repeat rate of 8.8% (n = 69/786) were established. The mean age of infants presenting for first HIV molecular test among accepted valid samples was 17.83 wk (95%CI: 17.65-18.01) vs 20.30 wk (95%CI: 16.53-24.06) for repeated samples. HIV infection rate was 9.8% vs 15.9% for accepted and repeated samples. Compared to tertiary healthcare clinics, secondary and primary clinics had two-fold and three-fold higher likelihood of sample rejection, respectively (P < 0.05). We observed a significant increase in sample rejection rate with increasing number of EID clinics (r = 0.893, P = 0.041). The major reasons for rejection were improper sample collection (26.3%), improper labeling (16.4%) and insufficient blood (14.8%).

CONCLUSION: Programs should monitor pre-analytical variables and incorporate continuous quality improvement interventions to reduce errors associated with sample rejection and improve patient retention.

Keywords: Human immunodeficiency virus, Prevention of mother-to-child transmission, Early infant diagnosis, Dried blood spot, Pre-analytical error, Sample rejection

Core tip: For early infant diagnosis of human immunodeficiency virus, the samples of choice are dried blood spots (DBS). DBS samples are received from over 100 health care centers at the Asokoro Laboratory Training Centre. When DBS arrives the laboratory, a technician receives the samples as well as all accompanying laboratory request forms and all relevant documentation. All routinely collected DBS samples are physically examined for quality and acceptability for molecular testing upon reception at the laboratory. Only samples that meet the laboratory acceptance criteria are usually tested. Samples which fail to meet the acceptance criteria are registered in the sample rejection logbook without being tested. All DBS samples accepted as fit-for-testing are electronically registered into the laboratory information management system (LIMS). The use of the LIMS reduces instances of transcriptional errors. DBS samples are processed using real-time PCR technology on the Cobas Taqman and Cobas ampliprep equipment. DBS samples are cut, eluted into solution, and then placed in the equipment where DNA extraction, amplification and detection is automatically carried out. Once results are ready, they are validated by the laboratory scientist for accuracy and completeness. If assay is judged to be a valid run, the assay is accepted with a click of a computer button.