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Successful Use of Near Point-of-Care Early Infant Diagnosis in NAMPHIA to Improve Turnaround Times in a National
Robert A Domaoal1, Katrina Sleeman1, Souleymane Sawadogo2
1Division of Global HIV & TB, CGH, CDC, International Laboratory Branch, Atlanta, GA.
Insights
Point-of-care early infant diagnosis (EID) testing using the GeneXpert platform in Namibia demonstrated high accuracy and significantly reduced turnaround times compared to the standard method. This approach is feasible for national HIV impact assessments, improving infant diagnosis and care.
Area of Science:
- Public Health
- Infectious Diseases
- Diagnostics
Background:
- Population-based HIV impact assessment surveys provide early infant diagnosis (EID) for infants under 18 months.
- The Namibia Population-Based HIV Impact Assessment (NAMPHIA) evaluated the GeneXpert platform for near point-of-care (POC) EID testing.
- Comparison focused on GeneXpert feasibility against the standard Roche COBAS AmpliPrep/COBAS TaqMan (CAP/CTM) platform, assessing quality assurance and turnaround time.
Purpose of the Study:
- To assess the feasibility of near point-of-care (POC) early infant diagnosis (EID) testing using the GeneXpert platform within the NAMPHIA survey.
- To compare the performance, quality assurance, and turnaround times of the GeneXpert platform with the standard Roche CAP/CTM platform for EID testing.
- To evaluate the potential of decentralized POC EID testing to improve diagnostic efficiency and infant outcomes.
Main Methods:
- Infants screened for HIV exposure using Determine HIV-1/2 rapid test.
- Determine-reactive samples underwent EID testing on the GeneXpert instrument with the Xpert HIV-1 Qual assay using whole blood.
- Results were confirmed via dried blood spots on the Roche CAP/CTM platform at the Namibia Institute of Pathology.
Main Results:
- 100% concordance was achieved between GeneXpert and Roche platforms for the 61 HIV-exposed infants.
- Average turnaround time for GeneXpert was 3.4 days (1.0 day from collection to testing), significantly faster than Roche (10.7 days).
- GeneXpert showed no sample failures, while Roche had one failure requiring a repeat.
Conclusions:
- Quality point-of-care (POC) EID testing is feasible in national surveys with adequate training and quality assurance.
- Decentralized POC EID testing offers rapid diagnosis, potentially reducing loss to follow-up.
- Improved turnaround times (TATs) can enhance linkage to care and improve clinical outcomes for HIV-exposed infants.
Background:
In the population-based HIV impact assessment surveys, early infant diagnosis (EID) was provided to infants <18 months without a prior diagnosis. For the Namibia population-based HIV impact assessment (NAMPHIA), the GeneXpert platform was assessed for the feasibility of near POC EID testing compared with the standard Roche COBAS AmpliPrep/COBAS TaqMan (CAP/CTM) platform. Quality assurance measures and turnaround time were compared to improve EID results reporting.
Methods:
NAMPHIA participants were screened for HIV exposure using Determine HIV-1/2 rapid test; samples reactive on Determine received EID testing on the GeneXpert instrument and Xpert HIV-1 Qual assay using whole blood. Results were confirmed at the Namibia Institute of Pathology using dried blood spots on the Roche CAP/CTM platform per national guidelines.
Results:
Of the 762 screened infants, 61 (8.0%) were Determine-reactive and considered HIV-exposed. Of the 61 exposed infants, 2 were found to be HIV-infected whereas 59 were negative on both GeneXpert and Roche platforms, achieving 100% concordance. Average turnaround time was 3.4 days for the Xpert HIV-1 Qual assay, and average time from collection to testing was 1.0 days for GeneXpert compared with 10.7 days for Roche. No samples failed using GeneXpert whereas 1 sample failed using Roche and was repeated.
Conclusion:
Quality POC EID testing is feasible in a national survey through extensive training and external quality assurance measures. The use of decentralized POC EID for national testing would provide rapid diagnosis and improve TATs which may prevent loss to follow-up, ensure linkage to care, and improve clinical outcomes for infants.
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