Discrepant test findings in Early Infant Diagnosis of HIV in a National Reference Laboratory in Kenya: Challenges and Opportunities for Programs

Kageha, Sheila; Okoth, Vincent; Kadima, Silvia; Vihenda, Stella; Okapesi, Elphas; Nyambura, Elizabeth; Maiyo, Alex; Ndungu, Nancy; Khamadi, Samoel; Mwau, Matilu

doi:10.1093/tropej/fmr076

Cited by 17 publications

(14 citation statements)

References 21 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…Indeterminate results during EID using CVAs are a significant challenge for HIV diagnostic services. False-positive results by CVAs were previously reported in other African countries (29,(33)(34)(35)(36)(37)(38)(39). In South Africa, 40 (5.6%) of 718 infants who initially tested HIV positive using Amplicor HIV-1 DNA v1.5 Test or Roche-dx-v1 were not infected after using serological testing in confirmatory specimens (28).…”

Section: Discussionmentioning

confidence: 87%

“…In Zambia, false-positive results using CVA were also reported in two infants (29). In the Kenyan EID Program, indeterminate results were more often negative than positive (35). Falsepositive results were provided in 3 (1.8%) of 166 uninfected infants using Roche-dx-v1 and 6 infants who were apparently positive resulted HIV negative later in time (35).…”

Section: Discussionmentioning

confidence: 99%

See 1 more Smart Citation

Evaluation of four commercial virological assays for early infant HIV-1 diagnosis using dried blood specimens

et al. 2016

View full text Add to dashboard Cite

show abstract

Section: Discussionmentioning

confidence: 87%

Section: Discussionmentioning

confidence: 99%

Evaluation of four commercial virological assays for early infant HIV-1 diagnosis using dried blood specimens

et al. 2016

View full text Add to dashboard Cite

show abstract

“…A study conducted in Kenya [18] to assess discrepant test results in their EID program presented interesting findings. Over 2.5% of what was classified as positive and over 1.88% of what was classified as negative by manual PCR assay, tested otherwise on retesting using the automated assay.…”

Section: Discussionmentioning

confidence: 99%

Adherence to Early Infant Diagnosis Testing Algorithm, a Challenge to Early Infant Diagnosis Program in Resource Limited Settings of Uganda

Kiyaga¹,

Lee²,

Allain³

2015

J HIV Clin Sci Res

View full text Add to dashboard Cite

Introduction: Early Infant Diagnosis (EID) targeting HIV exposed infants, happens over a period of time (6 weeks up to 18months), and employs different testing technologies at different testing time points. Being a process that is implemented over time and employing different testing technologies, a testing algorithm was designed to ensure reliable final diagnosis. This study was set out to estimate the level of adherence to the testing algorithm. Methods:Retrospective EID data was collected from 24 health facilities that covered the entire tier of the health system, from 4 geographic regions of Uganda. From each study site, all exposed infants that were tested in 2012 were tracked from the 1 st molecular test beginning at 6 weeks to the final rapid test at 18 months.Results: From the 24 study sites, 4221 exposed infants were tested with 1 st molecular test in 2012. Out of these, 3888 (92.1%) were HIV negative and 333 (7.9%) were HIV positive. Of the negative only 1543 (39.7%) did a 2 nd molecular test representing a loss of 60.3%. A total of 14 babies converted to HIV with the 2 nd molecular test, resulting in a total of 347 positive babies. Of the total positive babies, 212 (61.1%) initiated ART, representing a loss of 38.9%. Of the total who were screened with the 1 st molecular test, 1130 (26.8%) were tested with the final rapid test at 18 months, representing a loss of 73.2%. Discussion:The results indicate that, despite operational improvements, very poor adherence to EID testing algorithm was observed. This poor adherence may have an impact on the ultimate objectives of the whole program. Factors explaining high LTFU include; results long turnaround time (TAT), lack of patient follow-up mechanism, and poor patient counseling. There is therefore an urgent need to rethink the implementation of the EID program, not only in Uganda but also in other resourcelimited countries. Mechanisms of patient follow-up and linkage to care should be integrated into the testing process.

show abstract

“…Later in the same year, Roche developed another assay, the Roche CAPCTM Qual to meet the need of early infant diagnosis of HIV. The Roche CAPCTM Qual has been evaluated for early infant diagnosis by several laboratories (Schumacher et al, 2007; Stevens et al, 2008a; Jani et al, 2012) and being used in many countries where a large number of DBS samples are received routinely (Schumacher et al, 2007; Stevens et al, 2008a; Jani et al, 2012; Kageha et al, 2012; Maritz et al, 2012). …”

Section: Introductionmentioning

confidence: 99%

Field evaluation of Abbott Real Time HIV-1 Qualitative test for early infant diagnosis using dried blood spots samples in comparison to Roche COBAS Ampliprep/COBAS TaqMan HIV-1 Qual Test in Kenya

Chang

Omuomo

Anyango

et al. 2014

Journal of Virological Methods

View full text Add to dashboard Cite

Timely diagnosis and treatment of infants infected with HIV are critical for reducing infant mortality. High-throughput automated diagnostic tests like Roche COBAS AmpliPrep/COBAS TaqMan HIV-1 Qual Test (Roche CAPCTM Qual) and the Abbott Real Time HIV-1 Qualitative (Abbott Qualitative) can be used to rapidly expand early infant diagnosis testing services. In this study, the performance characteristics of the Abbott Qualitative were evaluated using two hundred dried blood spots (DBS) samples (100 HIV-1 positive and 100 HIV-1 negative) collected from infants attending the antenatal facilities in Kisumu, Kenya. The Abbott Qualitative results were compared to the diagnostic testing completed using the Roche CAPCTM Qual in Kenya. The sensitivity and specificity of the Abbott Qualitative were 99.0% (95% CI: 95.0–100.0) and 100.0% (95% CI: 96.0–100.0), respectively, and the overall reproducibility was 98.0% (95% CI: 86.0–100.0). The limits of detection for the Abbott Qualitative and Roche CAPCTM Qual were 56.5 and 6.9 copies/mL at 95% CIs (p = 0.005), respectively. The study findings demonstrate that the Abbott Qualitative test is a practical option for timely diagnosis of HIV in infants.

show abstract

Discrepant test findings in Early Infant Diagnosis of HIV in a National Reference Laboratory in Kenya: Challenges and Opportunities for Programs

Cited by 17 publications

References 21 publications

Evaluation of four commercial virological assays for early infant HIV-1 diagnosis using dried blood specimens

Evaluation of four commercial virological assays for early infant HIV-1 diagnosis using dried blood specimens

Adherence to Early Infant Diagnosis Testing Algorithm, a Challenge to Early Infant Diagnosis Program in Resource Limited Settings of Uganda

Field evaluation of Abbott Real Time HIV-1 Qualitative test for early infant diagnosis using dried blood spots samples in comparison to Roche COBAS Ampliprep/COBAS TaqMan HIV-1 Qual Test in Kenya

Contact Info

Product

Resources

About