Point of Care Diagnostics for HIV in Resource Limited Settings: An Overview
Abstract
:1. Introduction
2. Stages of HIV Infection
3. HIV Diagnostic Tests
3.1. HIV Rapid Tests
3.2. HIV Viral Load Measurement
3.2.1. Simple Amplification Based Assay (SAMBA)
3.2.2. EOSCAPE HIV
3.2.3. Liat™ Analyser
3.2.4. Alere™ q Analyser
3.2.5. GeneXpert® System
3.3. Early Infant Diagnosis of HIV
3.4. CD4 Tests
3.4.1. PointCare NOW™
3.4.2. CyFlow® miniPOC
3.4.3. Daktari™ CD4 Counter
3.4.4. MBio™Diagnostics CD4 System
3.4.5. Visitect CD4
3.4.6. BD FACSPresto
3.4.7. Zyomyx CD4 Test
3.4.8. Pima™ Analyser
4. Technical and Commercialization Challenges in POC Diagnostics for HIV
5. Future Prospects
6. Conclusions
Acknowledgments
Author Contributions
Conflicts of Interest
References
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Viral Load Tool | POC | Analyte | Detection Method | Time to Result | Sample Type and Volume | Additional Information |
---|---|---|---|---|---|---|
SAMBA | Yes | RNA | Isothermic amplification and Hapten-based signal detection | 90 min (SI 4 sample throughput, 24–48 tests/day), (SII 4 tests a day) | Plasma: 200 μL | Semi-quantitative; Detection: 1000 copies/mL Regulatory status: CE marked |
EOSCAPE HIV | Yes | RNA | Amplification/Detection | 50 min | Whole blood: 100, plasma: 100 μL | Qualitative and quantitative Detection threshold: 1000 copies/mL Regulatory status: NA |
Liat analyser | Yes | RNA | Multiplex Real-Time PCR Amplification/Detection | 30–35 min | Whole blood: 75 μL, plasma: 150 μL | Quantitative Detection threshold: 1000 copies/mL Regulatory status: In development |
Alere q analyser | Yes | RNA | Real time PCR/microprobe array | 52 min (8 h throughput, 8 tests) | Whole blood: 25 μL; plasma: 25 μL or 500 μL | Quantitative Detection threshold: 1000 copies/mL Regulatory status: CE marked |
GeneXpert | Near POC | RNA | Multiplex Real-Time PCR NA Amplification/Detection | 90 min | Plasma: 1 mL | Quantitative Detection range: 40–10,000,000 copies/mL Regulatory status: CE marked |
CD4 Tool | Analyte | Detection Method | Technology | Time to Result or Tests | Additional Information |
---|---|---|---|---|---|
PointCare NOW™ | CD4, CD4%, 12 blood parameters, haemoglobin | CD4 monoclonal antibody labelled with colloidal gold | Flow cytometry | 8 min | Measures blood, fully automated, portable, table top Regulatory status: FDA approved CE marked |
CyFlow® miniPOC | CD4, T cell, CD4% | Antibodies | Flow cytometry including laser modules, Optics, fluidics and electronics | 250 tests per day | Blood samples can be run one at a time or in batches, portable, compact Regulatory status: CE marked |
Daktari™ CD4 Counter | CD4 | Antibody, label free, functions without optics, lenses or cameras | Microfluidic cell chromatography and lysate impedance spectroscopy | 14 min | Portable, robust Regulatory status: NA |
MBio™Diagnostics CD4 System | CD4 and CD3 | Labelled antibodies | Imaging cytometry, immunostaining | +/−20 min per sample | Robust, uses low cost lasers Regulatory status: NA |
Visitect CD4 | CD4 on T cells | Antibodies, colloidal gold | Lateral flow | 40 min | Semi-quantitative CD4 > 350, CD4 > 500 Regulatory status: CE marked |
BD FACSPresto | CD4, %CD4 and haemoglobin | Fluorochrome conjugated antibody | Image based counting technology | 60 tests in 8 h | Cartridge contains dried reagents Regulatory status: CE marked WHO prequalification |
Zyomyx CD4 Test | CD4 | Antibodies | Mechanical mixer/spinner, capillary tube | 6 min | Instrument free Regulatory status: CE marked |
Pima™ Analyser | CD4, CD3 | Antibodies | Image based immune haematology test, fluorescence | 20 min | Good technical support, no routine maintenance Regulatory status: WHO prequalification |
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Manoto, S.L.; Lugongolo, M.; Govender, U.; Mthunzi-Kufa, P. Point of Care Diagnostics for HIV in Resource Limited Settings: An Overview. Medicina 2018, 54, 3. https://doi.org/10.3390/medicina54010003
Manoto SL, Lugongolo M, Govender U, Mthunzi-Kufa P. Point of Care Diagnostics for HIV in Resource Limited Settings: An Overview. Medicina. 2018; 54(1):3. https://doi.org/10.3390/medicina54010003
Chicago/Turabian StyleManoto, Sello Lebohang, Masixole Lugongolo, Ureshnie Govender, and Patience Mthunzi-Kufa. 2018. "Point of Care Diagnostics for HIV in Resource Limited Settings: An Overview" Medicina 54, no. 1: 3. https://doi.org/10.3390/medicina54010003