The Art of Writing and Implementing Standard Operating Procedures (SOPs) for Laboratories in Low-Resource Settings: Review of Guidelines and Best Practices

For a clinical study in the European research network on better diagnosis for neglected infectious diseases (NIDIAG) project (Better Diagnosis of Neglected Infectious Diseases: www.nidiag.org), we developed Standard Operating Procedures (SOPs), which we implemented in a basically equipped laboratory in a 380-bed rural hospital (“Hopital General de Reference Mosango”) in the Kwilu province in the Democratic Republic of the Congo (DRC). The study aimed to improve the early diagnosis of severe and treatable infections among patients with neurological disorders and took place over a 20-month period (14/09/2012–24/05/2014) (ClinicalTrials.gov Identifier: {"type":"clinical-trial","attrs":{"text":"NCT01589289","term_id":"NCT01589289"}}NCT01589289). The set of 50 SOPs (S1 Appendix), all in French, include procedures related to the inclusion and clinical management of patients with neurological disorders (n = 4), diagnostic testing (n = 33), data collection and management (n = 5), and quality assurance (n = 8).

[1]  C. Schofield,et al.  UNDP/World Bank/WHO special programme for research and training in tropical diseases (TDR) , 1989 .

[2]  S. Patil,et al.  Use of Google Translate in medical communication: evaluation of accuracy , 2014, BMJ : British Medical Journal.

[3]  P. Tavrow,et al.  Using quality design to improve malaria rapid diagnostic tests in Malawi. , 2000 .

[4]  Leonard Steinborn,et al.  International Organization for Standardization ISO/IEC 17025 General Requirements for the Competence of Testing and Calibration Laboratories , 2004 .

[5]  L. Wallace,et al.  Using a home blood pressure monitor: do accompanying instructional materials meet low literacy guidelines? , 2008, Blood pressure monitoring.

[6]  S. Lewis,et al.  OnlineOpen: This article is available free online at www.blackwell-synergy.com *Department of Haematology, , 2008 .

[7]  J. Jacobs,et al.  Assessment of the knowledge of graphical symbols labelled on malaria rapid diagnostic tests in four international settings , 2011, Malaria Journal.

[8]  E. Luman,et al.  A comprehensive review of the SLMTA literature part 1: Content analysis and future priorities , 2014, African journal of laboratory medicine.

[9]  P. Büscher,et al.  Single centrifugation of cerebrospinal fluid in a sealed pasteur pipette for simple, rapid and sensitive detection of trypanosomes. , 2000, Transactions of the Royal Society of Tropical Medicine and Hygiene.

[10]  Rune Pettersson,et al.  Cultural differences in the perception of image and color in pictures , 1982 .

[11]  J. Jacobs,et al.  Malaria rapid diagnostic kits: quality of packaging, design and labelling of boxes and components and readability and accuracy of information inserts , 2011, Malaria Journal.

[12]  Osama M. E. Seidahmed,et al.  End‐user errors in applying two malaria rapid diagnostic tests in a remote area of Sudan , 2008, Tropical medicine & international health : TM & IH.

[13]  Richard C. Friedberg,et al.  International Organization for Standardization (ISO) 15189 , 2017, Annals of laboratory medicine.

[14]  Steven E Roskos,et al.  Readability Characteristics of Consumer Medication Information for Asthma Inhalation Devices , 2006, The Journal of asthma : official journal of the Association for the Care of Asthma.

[15]  James E. Purpura,et al.  Linguistic and Cultural Challenges in Communication and Translation in US-Sponsored HIV Prevention Research in Emerging Economies , 2015, PloS one.

[16]  M. Leeflang,et al.  Systematic reviews of diagnostic test accuracy for evidence-based diagnostic practice in Africa , 2011, African Journal of Laboratory Medicine.

[17]  Ezekiel J Emanuel,et al.  What makes clinical research in developing countries ethical? The benchmarks of ethical research. , 2004, The Journal of infectious diseases.

[18]  V. Jamonneau,et al.  Improved Models of Mini Anion Exchange Centrifugation Technique (mAECT) and Modified Single Centrifugation (MSC) for Sleeping Sickness Diagnosis and Staging , 2009, PLoS neglected tropical diseases.

[19]  Socorro Lupisan,et al.  Minimising human error in malaria rapid diagnosis: clarity of written instructions and health worker performance. , 2007, Transactions of the Royal Society of Tropical Medicine and Hygiene.

[20]  Sheila K West,et al.  Presbyopia: prevalence, impact, and interventions. , 2007, Community eye health.

[21]  Catherine Acquadro,et al.  Literature review of methods to translate health-related quality of life questionnaires for use in multinational clinical trials. , 2008, Value in health : the journal of the International Society for Pharmacoeconomics and Outcomes Research.

[22]  Jan Jacobs,et al.  Harmonization of malaria rapid diagnostic tests: best practices in labelling including instructions for use , 2014, Malaria Journal.

[23]  P. Klatser,et al.  Review and comparison of quality standards, guidelines and regulations for laboratories , 2011, African journal of laboratory medicine.

[24]  Cynna Selvy,et al.  Clinical Laboratory Improvement Amendments (CLIA) , 2015 .