External quality assessment for HIV rapid tests: challenges and opportunities in Haiti.

HIV rapid diagnostic tests (RDTs) are instrumental in scaling-up HIV testing services (HTS) in low-income and middle-income countries (LMICs). HIV misdiagnosis is a growing concern in the era of expanded and decentralised access to HTS. External quality assurance (EQA) programme including proficiency testing (PT) for HIV RDTs is a priority to guarantee the accuracy and reliability of the patients' result. Here we are sharing Haiti's 11 years' experience in implementing HIV RDTs EQA programme to help address some of the challenges faced by other LMICs. HTS is expanding beyond laboratory walls and HIV RDTs are increasingly performed by non-laboratory personnel and closer to the community. EQA programmes for HIV RDTs in Haiti have faced significant challenges. In expanded HTS settings, non-laboratory personnel (nurses, aid-nurses) involved in HIV RDT are usually undertrained and participate poorly in PT programs. In more than half of the lab enrolled in the PT programme in Haiti, the panels are always tested by the most experienced technician, defying the purpose of the program which is to evaluate the performance of the technician performing the test daily. EQA programme in Haiti and other LMICs are usually not tailored to address community HIV testing challenges. With decreased funding and absence of government financial commitment to HIV RDTs EQA programmes, more innovative and cost-efficient strategies are sought to ensure the quality of HIV diagnosis in LMICs. Qualified human resources, continuous training, supervision and community-tailored PT programmes remain key components for the success of HIV RDT quality management.

Building and Rebuilding: The National Public Health Laboratory Systems and Services Before and After the Earthquake and Cholera Epidemic, Haiti, 2009-2015.

Before the 2010 devastating earthquake and cholera outbreak, Haiti's public health laboratory systems were weak and services were limited. There was no national laboratory strategic plan and only minimal coordination across the laboratory network. Laboratory capacity was further weakened by the destruction of over 25 laboratories and testing sites at the departmental and peripheral levels and the loss of life among the laboratory health-care workers. However, since 2010, tremendous progress has been made in building stronger laboratory infrastructure and training a qualified public health laboratory workforce across the country, allowing for decentralization of access to quality-assured services. Major achievements include development and implementation of a national laboratory strategic plan with a formalized and strengthened laboratory network; introduction of automation of testing to ensure better quality of results and diversify the menu of tests to effectively respond to outbreaks; expansion of molecular testing for tuberculosis, human immunodeficiency virus, malaria, diarrheal and respiratory diseases; establishment of laboratory-based surveillance of epidemic-prone diseases; and improvement of the overall quality of testing. Nonetheless, the progress and gains made remain fragile and require the full ownership and continuous investment from the Haitian government to sustain these successes and achievements.

Evaluation of an external quality assessment program for HIV testing in Haiti, 2006-2011.

OBJECTIVES: To evaluate an external quality assessment (EQA) program for human immunodeficiency virus (HIV) rapid diagnostics testing by the Haitian National Public Health Laboratory (French acronym: LNSP). Acceptable performance was defined as any proficiency testing (PT) score more than 80%. METHODS: The PT database was reviewed and analyzed to assess the testing performance of the participating laboratories and the impact of the program over time. A total of 242 laboratories participated in the EQA program from 2006 through 2011; participation increased from 70 laboratories in 2006 to 159 in 2011. RESULTS: In 2006, 49 (70%) laboratories had a PT score of 80% or above; by 2011, 145 (97.5%) laboratories were proficient (P < .05). CONCLUSIONS: The EQA program for HIV testing ensures quality of testing and allowed the LNSP to document improvements in the quality of HIV rapid testing over time.

Seroprevalence of measles and rubella antibodies in pregnant women Haiti, 2012.

BACKGROUND: Haiti had set a national goal to eliminate measles and rubella, as well as congenital rubella syndrome (CRS) by 2010. A 2007-2008 nationwide measles and rubella vaccination campaign targeting 1-19 years, however, reached only 79% of the target population. To assess whether population immunity was adequate to support elimination, we conducted a national serosurvey. METHODS: We systematically selected 740 serum specimens collected from pregnant women in a 2012 national antenatal HIV sentinel serosurvey across four age strata: 15-19, 20-24, 25-29 and 30-39 years. Sera were tested for measles and rubella specific immunoglobulin G antibodies (IgG) using commercial immunoassays. We classified sera as seropositive, seronegative or indeterminate per manufacturer's instructions, and analyzed seroprevalence according to age strata, and rural or urban residence. We assessed immunity by estimating antibody concentrations in international units per milliliter (IU/mL) for seropositive and indeterminate sera. Measles IgG concentrations >0.12 IU/mL and rubella IgG concentrations >10 IU/mL were considered clinically protective. RESULTS: Of 740 sera, 696 (94.1%) were seropositive and 20 (2.7%) were indeterminate for measles IgG; overall 716 (96.8%) sera had IgG concentrations >0.12 IU/mL. For rubella IgG, 691 (93.4%) sera were seropositive and 1 (0.1%) was indeterminate; a total of 687 (92.8%) had IgG concentrations >10 IU/mL. Measles seropositivity varied across age strata (p=0.003); seropositivity increased from 88.6% among 15-19 year olds to 98.4% among 30-39 year olds (Cochran-Armitage trend tes t ≤ 0.0001). Rubella seropositivity did not differ across age strata. There were no statistically significant differences in measles or rubella seropositivity by urban versus rural residence. CONCLUSION: Despite previous low vaccination coverage for measles, results from this serosurvey indicate high levels of measles and rubella seropositivity in pregnant women, and contribute to the evidence for measles, rubella and CRS elimination from Haiti by the target date.

Seroprevalence of antibodies against rubella virus in pregnant women in Haiti.

OBJECTIVE: To assess the seroprevalence of immunity to the rubella virus in pregnant women in Haiti attending the Obstetrics and Gynecology Department of the State University Hospital, in the capital city of Port-au-Prince, in order to help with the introduction of the rubella vaccine for the population and provide protection for women of reproductive age in the country. METHODS: This cross-sectional study was done between February 2002 and May 2002. A total of 503 pregnant women were tested for rubella-specific immunoglobulin G antibodies, using enzyme immunoassay; 8 of those women were later excluded because they did not know their age, leaving 495 women in the analysis. RESULTS: Of the 495 participants included in our analysis, 471 of them (95.2%) were seropositive; only 24 of them (4.8%) were seronegative (susceptible). A statistically significant difference (P = 0.02) was found in the rate of seronegativity for rubella virus between the pregnant women living in the Port-au-Prince area (17 of 426 women, or 4.0%) and those living in rural areas (7 of 69 women, or 10.1%). In terms of age, 81 of the 495 (16.4%) women were under 21 years ld. CONCLUSIONS: This study is an important first step in addressing the issue of prevalence of rubella virus infection among Haitian women and in dealing with the still-underrecognized public health problem of congenital rubella syndrome in Haiti. We recommend additional research that uses randomized sampling and includes a significant proportion of women from rural areas of the country.

Seroprevalence of antibodies against rubella virus in pregnant women in Haiti

OBJETIVO: Determinar la seroprevalencia de la inmunidad al virus de la rubéola en mujeres embarazadas que se atienden al Departamento de Obstetricia y Ginecología del Hospital de la Universidad Estatal, en Puerto Príncipe, capital de Haití, a fin de contribuir a introducir la vacunación de la población contra la rubéola y proteger a las mujeres en edad reproductiva en el país. MÉTODOS: Este estudio transversal se realizó entre febrero y mayo de 2002. Se evaluó la presencia de anticuerpos de tipo IgG específicos contra la rubéola en 503 embarazadas mediante un inmunoensayo enzimático. Posteriormente se excluyó a 8 mujeres debido a que no sabían su edad. RESULTADOS: De las 495 participantes estudiadas, 471 (95,2%) tenían seropositividad; solo 24 de ellas (4,8%) mostraron seronegatividad (susceptibilidad). Se encontraron menos mujeres seronegativas entre las residentes de Puerto Príncipe (17 de 426, 4,0%) que entre las residentes de zonas rurales (7 de 69, 10,1%) (P = 0,02). En relación con la edad, 81 (16,4%) de las 495 mujeres embarazadas estudiadas eran menores de 21 años. CONCLUSIONES: Con este estudio se da el primer paso hacia evaluar la prevalencia de la infección por el virus de la rubéola en mujeres haitianas y hacia el enfrentamiento de un problema de salud que todavía no ha sido reconocido en toda su magnitud: el síndrome de la rubéola congénita en Haití. Se recomienda emprender estudios adicionales con muestreos aleatorios que abarquen una fracción significativa de mujeres provenientes de zonas rurales.