Introduction

Sexually transmitted infections (STIs) are an important public health issue in the Pacific region. STIs can have serious medical and social health impacts. For example, they contribute to poor reproductive health outcomes such as infertility and stillbirth, they can cause serious problems for the baby during pregnancy and delivery, and they can enhance the transmission of HIV.

Exciting new diagnostic tests are being developed for STIs that may transform how these infections are diagnosed. Together with effective single-dose treatments, tests performed by health staff at the point-of-care (POC) may lead to improvements in medical, resource, operational, and financial outcomes. Some Pacific Island Countries and Territories are already using POC tests to diagnose STIs. On the other hand, not all tests need to be POC tests, and there are potential risks in introducing these tests even when the POC test itself has all the qualities of an optimal test.

What is the purpose of this toolkit?

This document provides a guide for the planning, implementation and evaluation of POC tests for STIs in order to take account of the complexities of introducing such tests and to avoid some of the pitfalls.

The toolkit should support health managers to critically appraise the suitability of POC testing for STIs in their country, ensure a smooth introduction if deemed appropriate, and minimise harms. People seeking to review, strengthen or change an existing STI testing program may also find the toolkit to be of use, as may policy makers themselves.

How to use this toolkit

The toolkit is divided into three sections:

  1. Section 1: Initial Assessment – this section provides advice on how to weigh up the benefits and costs of introducing an STI POC test including background information on key definitions and technical concepts
  2. Section 2: Piloting the STI POC test - this section outlines the key steps in preparing for and managing the implementation of a pilot test to determine how well the POC test performs in the local setting
  3. Section 3: Scaling up - this section briefly discusses the principles of using the POC test on a wider scale

Each section contains a number of subsections that are linked or overlapping in some way. They can be read as sequential steps or referred to separately as needed. Each subsection has:

Development history

The Secretariat of the Pacific Community via the Pacific Response Fund supported the Burnet Institute to develop this toolkit in 2011.

The Pacific Regional STI Working Group, a group established to provide evidence-based recommendations to countries to help reduce the prevalence of STIs such as chlamydia, gonorrhoea and syphilis, had a role in the development and review of the Toolkit. The Working Group comprises technical specialists from the Secretariat of the Pacific Community (SPC), the Centers for Disease Control and Prevention (CDC), the Oceania Society for Sexual Health and HIV Medicine (OSSHHM), the United Nations Children’s Fund (UNICEF), the United Nations Population Fund (UNFPA), and the World Health Organization (WHO).

Key members of the following agencies supported the development of the toolkit: Fiji Ministry of Health; the Papua New Guinea Ministry of Health; Solomon Islands Ministry of Health; Vanuatu Ministry of Health; Fiji School of Medicine; Matika House, Fiji; CWM Hospital, Fiji; STI Clinic Suva, Fiji; National Serology Reference Laboratory, Australia; Pacific Paramedical Training Centre; Wan Smolbag, Vanuatu.

The following experts assisted with drafting specific elements of the toolkit: Susan Best and Wayne Dimech from NRL, Dr Janet Knox and Dr Greg Law (sexual health specialists), Steve Badman (epidemiologist), and Dr Dermot Hurly (general practitioner).

The document will be periodically revised based on feedback from users in the Pacific.

Basic information about POC tests

What is a POC test?

"Diagnostic testing performed at or near the site of patient care"

Kost, GJ. Guidelines for point-of-care testing: improving patient outcomes American Journal of Clinical Pathology 1995; 104 (Sup1): S111-S127

"Analytical patient testing activities… performed outside the physical facilities of the clinical laboratories It does not require permanent dedicated space, but instead includes kits and instruments, which are either hand carried or transported to the vicinity of the patient for immediate testing at that site"

College of American Pathologists

Also called: ancillary testing, bedside testing, alternate site testing and decentralized testing

Note that POC tests don't have to be kits. Microscopy for the detection of trichomonas, for example, could be conducted in frontline health facilities and could be considered a POC test.

What features does an optimal POC have?

Qualities of an Optimal Point-of-Care Test
Minimal cost Rapid availability of test results
Low maintenance Results applicable to clinical decision making
Minimal or no use of blood Simple, easy to perform testing methodology
Portability of testing equipment Stability of testing equipment in a variety of different environments
Easy interpretation of test results & minimal variability in test results Test results closely match results of standard laboratory procedures
Hudson MP, Christenson RH, Newby LK, Kaplan AL, Ohman EM Cardiac markers: point of care testing Cin Chim Acta 1999;284:223-37

What are some of the potential benefits and problems with a POC test?

Potential Benefits Potential Problems
Reduced time to make clinical decisions Risk of errors in diagnosis and treatment
Patient knows result quickly at the point of care and is more likely to receive appropriate treatment Additional training and quality control requirements
Improved patient care and medical outcomes (reduced morbidity and mortality, improved fertility etc.) Additional work for clinical staff
Improved opportunities for partner management Unregulated use of test
Improved coverage of STI testing Selection of an inappropriate test
Reduced load on laboratories allowing staff to focus on other work areas Health risk to staff performing rapid tests (e.g. exposure to contaminated body fluids)
Cost savings (in the long term) in highly decentralized testing settings (though costs may be higher initially with increased case detection and treatment) Additional costs for kits and consumables

Next: 1.0 Initial Assessment

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