The Advantages and Challenges of Point-of-Care Laboratory Machines

By Luigi Cicció
Strengthening TB and AIDS Response – Eastern Region Project, MSH Uganda

In yesterday’s ICASA satellite session on “Laboratories and Facilities,” all presenters emphasized that point-of-care (POC) laboratory machines are both useful and possible. Their usefulness was never in question, but their feasibility was.

There are now several laboratory machines that can be used by trained personnel at primary health care level to perform tests that have traditionally been carried out by referral laboratories. They can help in providing cluster of differentiation 4 (CD4) count, viral load (VL) and bio-chemistry tests, all necessary for determining antiretroviral therapy (ART) eligibility and monitoring its effectiveness in the long term. It is an emerging market where companies are investing and competing with one another, thus making costs for purchasing and installing these POC machines more affordable.

Their advantages are evident: they can contribute to scaling up ART services and thus, reach out to more people in need with minimal referral to higher level sites (decreasing losses to follow up). The tests are not complex and can allow for task shifting to a lower laboratory cadre, results can be delivered in few minutes and do not require clients to turn up again, costs of reagents are acceptable, and maintenance is limited. Also, proficiency testing of POC laboratories can be accomplished for quality assurance.

All these programmatic benefits do not come without challenges though.

In rural places with limited (and erratic) availability of power, these machines may not reach their expected efficiency level. Shortage of consumables is another serious obstacle that is often under-estimated along with the logistical chain of ordering, procuring and distributing to remote areas. The increased number of clients attending ART clinics will translate in an increased number of tests and eventually in overburdening the existing laboratory personnel.

Some obvious yet crucial questions remain: according to the new World Health Organization guidelines, the VL is the test recommended for ART patient monitoring. But how acceptable is the performance of our ART sites with POC CD4 machines? How many tests per client per year do they provide? How many new ART clients are enrolled based on their CD4 test? And how many are still enrolled with a CD4 count below 100?

Three of the countries that have started implementing the option B+ approach, namely Malawi, Swaziland and Uganda, shared their recent experiences in a well attended plenary session on “Integrated Service Delivery Models,” where respective Ministry of Health (MOH) representatives described the significant modifications, adaptations, and innovations they had put in place for delivering prevention of mother to child transmission (PMTCT) and early infant diagnosis (EID) services.

In Malawi, the MOH took almost one and half year from policy formulation to actual implementation. This was necessary to plan for resource mobilization, training and procurement; to produce guidelines, training manuals and data tools; to institute a procurement process for antiretrovirals (ARVs); to conduct capacity building, and to initiate mentorship of health workers at all levels.

Their model highlighted the importance of integrating ART into maternal, newborn, and child health (MNCH) care through provision of HIV testing, ART, and clinical follow up of mothers and exposed infants in one setting.

The main threats to retention were found to be: ART initiation on the same day of detection of the HIV positive status; too much information given to mothers (about HIV, PMTCT, drug adherence, need for follow up, etc.); and the fact that many mothers were still healthy to accept lifelong treatment. Also, male involvement was not adequate (how could it be any different, since men need to reach eligibility status to qualify for ARV?). However, option B+ approach was scaled up and Malawi graduated as the pioneer country and their implementation model inspired others.

The Swaziland MOH ensured that PMTCT services were totally free of charge; completed the accreditation process of primary health unit (PHU) clinics to allow the scale up; provided POC CD4 machines in most facilities and recommended task sharing and shifting.

To promote retention, they put in place the following:

  • All services were made available in each facility (no referral)
  • CD4 test results were delivered the same day
  • Mother and infant clinic appointments were synchronized to happen the same day under the same roof (“family day” in ART clinics)
  • Children were discharged from the MNCH care point at 24 months of age (and they are considering to extend this to 5 years of age for continuity)
  • They used SMS technology and community health workers (CHWs) for follow up and tracing of missed appointments

Though the uptake of ART by pregnant mothers and children younger than 15 years of age increased from 45% to 75% and from 55% to 70% in three years respectively, they recognized some challenges:

  1. PHU clinics are becoming overcrowded
  2. Infrastructures are not suitable to accommodate the added services
  3. There is high burn out of CHWs
  4. SMS use is limited by hampered availability of mobile phones
  5. The human resources needed for the follow up are not sufficient

The Uganda presentation described their approach on the demand side and specifically the community engagement. Communities were seen as resources to generate service demand, strengthen linkages, reduce the human resource constraints, and addressing MNCH care bottlenecks like mobilizing people, following up and involving males.

The First Lady stepped in as the ending mother to child transmission of HIV (eMTCT) champion attending all 4 regional launches. People living with HIV/AIDS (PLHIV) networks were also involved; community resource people like village health teams and traditional birth attendants became linkage facilitators; family support groups were instituted in most facilities; and mentor mothers were trained and deployed to assist their peers.

Among the preliminary results, 94% of women attend antenatal care at least once (but only 17% during their first trimester); and last year about 88,000 HIV+ mothers received ART (51,000 option B+, 25,000 HAART and 12,000 option A) out of 120,000 detected cases.

Several challenges still persist: only 50% of facilities have an established FSG, adherence monitoring is limited, men involvement at PMTCT setting is at 15%, and community data collection tools are inadequate to capture all activities taking place.

Surprisingly, none of the presenters quoted any figure on the retention of mothers enrolled into option B+. Nor did they mention data issues as one of the implementation challenges. Yet, this was one of the most sensitive concerns that were cited at a B+ review meeting recently held by the Uganda MOH.

PMTCT data tools in Uganda have been changing much faster than the adapting attitude of health workers. Instructions for data recording have been modified and more indicators added, increasing the complexity of the whole exercise and perhaps compromising the overall accuracy of the data.

Could we simply have not more than 10 indicators for the PMTCT-EID cascade and make an effort to capture them correctly?