Opportunities and Challenges for Cost-Efficient Implementation of New Point-of-Care Diagnostics for HIV and Tuberculosis

Abstract

Stakeholders agree that supporting high-quality diagnostics is essential if we are to continue to make strides in the fight against human immunodeficiency virus (HIV) and tuberculosis. Despite the need to strengthen existing laboratory infrastructure, which includes expanding and developing new laboratories, there are clear diagnostic needs where conventional laboratory support is insufficient. Regarding HIV, rapid point-of-care (POC) testing for initial HIV diagnosis has been successful, but several needs remain. For tuberculosis, several new diagnostic tests have recently been endorsed by the World Health Organization, but a POC test remains elusive. Human immunodeficiency virus and tuberculosis are coendemic in many high prevalence locations, making parallel diagnosis of these conditions an important consideration. Despite its clear advantages, POC testing has important limitations, and laboratory-based testing will continue to be an important component of future diagnostic networks. Ideally, a strategic deployment plan should be used to define where and how POC technologies can be most efficiently and cost effectively integrated into diagnostic algorithms and existing test networks prior to widespread scale-up. In this fashion, the global community can best harness the tremendous capacity of novel diagnostics in fighting these 2 scourges.

Harmonization of clinical laboratories in Africa: a multidisciplinary approach to identify innovative and sustainable technical solutions

“…Primary health laboratories should manage HIV/AIDS, malaria, tuberculosis (TB) [15], syphilis, various infections, noncommunicable diseases, endemic diseases such as human African trypanosomiasis, and pregnancy. It is also deemed necessary for primary facilities to implement diagnostic techniques for clinical chemistry and hematology.…”

The BACTEC MGIT(tm) 320 system as a laboratory tool to diagnose tuberculosis in a Brazilian hospital with a high prevalence of HIV infection

“…An important aspect of culture methods is turn-around, which has been reported to be shorter for MGIT (10-15 days) than for solid media (20-40 days) (2) . In line with these observations, the gap between a positive test on microscopy and a confi rmed diagnosis was 8.8 days for MGIT and 17.3 days for OgawaKudoh cultures (Table 2).…”

“…Thus, early detection is essential (2) . Tuberculosis can be diagnosed by sputum smear microscopy for acid-fast bacilli.…”

“…However, culture on solid media requires 20-40 days. In contrast, systems such as the Mycobacterial Growth Indicator Tube (MGIT), which are commercially available and are based on liquid media, require only 10-15 days (2) .…”

Laboratory Evaluation of the Liat HIV Quant (IQuum) Whole-Blood and Plasma HIV-1 Viral Load Assays for Point-of-Care Testing in South Africa

“…Complexities related to logistics and sample transport to ensure RNA integrity in blood specimens is one limitation to providing full access to VL testing (8). Solutions to increasing access to VL testing being investigated are the use of dried blood spots (9)(10)(11), which are easy to transport and appear to extend sample RNA integrity (12), and on-site (point-of-care [POC]) VL testing (without requiring specimen transport and potential loss of specimen integrity) (13). POC VL testing, however, has been slow in commercialization, especially for large-scale implementation programs, such as that in South Africa.…”