CD4 quantification based on magneto ELISA for AIDS diagnosis in low resource settings

Carinelli, Soledad; Xufré, Cristina; Alegret, Salvador; Pividori, María Isabel

doi:10.1016/j.talanta.2016.06.055

Cited by 14 publications

(13 citation statements)

References 27 publications

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“…To provide cheaper and simpler services, alternative enumeration methods were initially adopted, i.e. manual CD4 counts or use of parameters such as the total lymphocyte count or CD4 percentage of lymphocytes as predictive indicators of the impact of HIV infection on the immune system [ 34 – 40 ]. The unfolding HIV pandemic and growing numbers of patients requiring care however provided an impetus for the rapid evolution of new generation flow cytometric CD4 T-cell enumeration systems to meet the needs of varying service delivery/test volumes.…”

Section: Discussionmentioning

confidence: 99%

Performance verification of the new fully automated Aquios flow cytometer PanLeucogate (PLG) platform for CD4-T-lymphocyte enumeration in South Africa

Coetzee

Glencross

2017

PLoS ONE

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BackgroundThe National Health Laboratory Service (NHLS) offers wide-scale CD4 testing through a network of laboratories in South Africa. A new “load and go” cytometer (Aquios CL, Beckman Coulter), developed with a PLG protocol, was validated against the predicate PLG method on the Beckman Coulter FC500 MPL/CellMek platform.MethodsRemnant routine EDTA blood CD4 reference results were compared to results from two Aquios/PLG instruments (n = 205) and a further n = 1885 samples tested to assess daily testing capacity. Reproducibility was assessed using ImmunotrolTM and patient samples with low, medium, high CD4 counts. Data was analyzed using GraphPad software for general statistics and Bland-Altman (BA) analyses. The percentage similarity (%Sim) was used to measure the level of agreement (accuracy) of the new platform versus the predicate and variance (%SimCV) reported to indicate precision of difference to predicate.Results205 samples were tested with a CD4 count range of 2–1228 cells/μl (median 365cells/μl). BA analysis revealed an overall -40.5±44.0cells/μl bias (LOA of 126.8 to 45.8cells/μl) and %Sim showing good agreement and tight precision to predicate results (94.83±5.39% with %SimCV = 5.69%). Workflow analysis (n = 1885) showed similar outcomes 94.9±8.9% (CV of 9.4%) and 120 samples/day capacity. Excellent intra-instrument reproducibility was noted (%Sim 98.7±2.8% and %SimCV of 2.8%). 5-day reproducibility using internal quality control material (Immunotrol™) showed tight precision (reported %CV of 4.69 and 7.62 for Normal and Low material respectively) and instrument stability.ConclusionThe Aquios/PLG CD4 testing platform showed clinically acceptable result reporting to existing predicate results, with good system stability and reproducibility with a slight negative but precise bias. This system can replace the faded XL cytometers in low- to medium volume CD4 testing laboratories, using the standardized testing protocol, with better staff utilization especially where technical skills are lacking. Central monitoring of on-board quality assessment data facilitates proactive maintenance and networked instrument performance monitoring.

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Section: Discussionmentioning

confidence: 99%

Performance verification of the new fully automated Aquios flow cytometer PanLeucogate (PLG) platform for CD4-T-lymphocyte enumeration in South Africa

Coetzee

Glencross

2017

PLoS ONE

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“…Moreover, the use of magnetic particles can simplify the analytical procedure, avoiding the use of classical centrifugation or chromatography separation strategies, since pre‐enrichment and purification required for sample analysis are achieved simply by applying an external magnet. These magnetic particles could be used not only as a solid support, but also as a label for detection . This latter is particularly interesting when using magnetic nanoparticles (MNPs, φ≤100 nm) as tags for signal amplification .…”

Section: Viral Infectionsmentioning

confidence: 99%

“…These magnetic particles could be used not only as a solid support, but also as a label for detection. [4,23] This latter is particularly interesting when using magnetic nanoparticles (MNPs, f 100 nm) as tags for signal amplification. [24] The higher surface-to-volume ratio of MNPs provides many more sites for biomolecules binding and allows lower LOD values to be attained.…”

Section: Electrochemical Biosensing Of Viral Infectionsmentioning

confidence: 99%

“…Recent guidelines published by WHO recommend that diagnostic devices for developing countries should be affordable (A), Sensitive (S), Specific (S), User‐friendly (U), Rapid and Robust (R), Equipment free (E), and Deliverable (D) to those who need it (summarized under the acronym ASSURED). Technologies which meet these demands would be also very useful for point‐of‐care in small health centers in middle and high‐income countries for getting the result back at the moment, as well as for following‐up and prescribing the correct treatment without delay avoiding thus high test turnaround time . Modern detection methods have been refined and even improved, with an eye towards reducing the time to detection.…”

Section: Introductionmentioning

confidence: 99%

“…Technologies which meet these demands would be also very useful for point-of-care in small health centers in middle and high-income countries for getting the result back at the moment, as well as for following-up and prescribing the correct treatment without delay avoiding thus high test turnaround time. [3,4] Modern detection methods have been refined and even improved, with an eye towards reducing the time to detection. Among them, rapid immunological or molecularbased assays including immunological assays, DNA hybridization, and polymerase chain reaction (PCR) methods should be highlighted.…”

Section: Introductionmentioning

confidence: 99%

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Electrochemical Biosensing for the Diagnosis of Viral Infections and Tropical Diseases

2017

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Rapid and reliable diagnosis of viral infections and tropical diseases and timely initiation of appropriate treatment are essential for their successful clinical management. This Review summarizes some basic concepts regarding the main viral infection and tropical diseases to which society is facing today and the conventional methods available for their detection. The tremendous potential offered by electrochemical affinity biosensors to address this important challenge, meeting the required demands for viral infections and tropical diseases diagnosis, is clearly stated by discussing challenges, opportunities, implementation, and application of selected examples focused on the determination of specific biomarkers of different molecular (genetic, regulatory, and functional) levels. The highlighted approaches demonstrate the use of a plethora of specific receptors and assay formats and a great diversity of attractive electrochemical approaches in this rapidly advancing and highly interesting field.

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Graphene FET Biosensor Based on the Avidin–Biotin Technology

Wang

Hossain

Zhao

et al. 2021

Graphene Field-Effect Transistor Biosensors

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Avidin-biotin interaction is the strongest known protein-ligand interaction and is widely used in the field of biomedicine, including immunochromatography and various biological detection technologies. Because avidin or streptavidin can specifically bind to four biotinylated molecules efficiently and quickly, and the biotinylated molecules will not change their inherent characteristics. At present, this avidin-biotin interaction has been widely used in the field of biomedical detection to amplify biological signals for specific molecules. Combined with the graphene fieldeffect transistor biosensor, using the avidin-biotin interaction, the concentration of specific molecules in the test solution is expected to be amplified by the biotin-avidin interaction, which helps to increase the limit of detection for the biosensor. Besides, based on the avidin-biotin interaction, the graphene field-effect transistor biosensor is expected to rapidly quantitative detect free biotin and biotinylated molecules. This chapter mainly introduces the graphene field-effect transistor biosensor from the perspectives of device preparation, surface modification, sensitivity, and specificity, and discusses the possible situations that the sensor may encounter in actual detection.Avidin-biotin technology is widely used in different types of ELISA (enzyme-linked immunosorbent assay) kits, polymer-based detection and labeled immunosensor s for the detection of different bio-markers linked to different diseases such as cancer and influenza. In this section, we introduced the employing avidin-biotin technology in the graphene FET biosensor and demonstrated the specific detection of the biotinylated biomolecule in the sub-pico molar (pM) range. The sensing performance of graphene FET biosensor was characterized by the real-time two-terminal electrical current measurement upon injection of analyte solution into a silicone pool preattached onto the graphene channel. Since the Avidin-biotin technology has strong affinity and specificity, any biotinylated biomolecules are hopping for rapid detecting with ultra-low concentration level through this sensing platform. Thus the present graphene FET biosensor is expected to be a breakthrough in biomedical analysis. It can be used as a potential common platform for the rapid and point of care detection of different biomolecules and biomarkers linked to different diseases.

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CD4 quantification based on magneto ELISA for AIDS diagnosis in low resource settings

Cited by 14 publications

References 27 publications

Performance verification of the new fully automated Aquios flow cytometer PanLeucogate (PLG) platform for CD4-T-lymphocyte enumeration in South Africa

Performance verification of the new fully automated Aquios flow cytometer PanLeucogate (PLG) platform for CD4-T-lymphocyte enumeration in South Africa

Electrochemical Biosensing for the Diagnosis of Viral Infections and Tropical Diseases

Graphene FET Biosensor Based on the Avidin–Biotin Technology

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