Field Performances of Rapid Diagnostic Tests Detecting Human Plasmodium Species: A Systematic Review and Meta-Analysis in India, 1990–2020
Abstract
:1. Introduction
2. Materials and Methods
2.1. Ethical Statement
2.2. Electronic Databases
2.3. Search Strategy
2.4. Objectives
2.5. Eligibility Criteria
2.6. Screening Strategy
2.7. Data of Interest
2.8. Methodological Quality Assessment of Studies
2.9. Data Verification for Consistency
2.10. Outcomes to Appraise Field Performances
2.11. Data Management
3. Results
3.1. Selection Process Results
3.2. Geographical Distribution of the Included Studies
3.3. Characteristics of the Included Studies
3.4. Gold Standard Used to Evaluate the Performances of RDTs
3.5. Characteristics of RDTs Evaluated
3.6. Methodological Quality of Included Studies
3.7. Detection of Plasmodium spp. Species
3.8. Detection of P. Falciparum
3.9. Detection of P. vivax
3.10. Paired Comparison of Performances of RDT for P. falciparum and P. vivax
3.11. Detection of Non-Falciparum Species
3.12. Detection of Mixed Infections
3.13. Gametocyte Carriage and RDT Positivity
3.14. Intensity of RDT Test Line and Parasitemia
3.15. RDT Performances and Level of Parasitemia
3.16. RDT Performances against P. falciparum Isolates with Pfhrp2 Deletions
4. Discussion
5. Limitations of this Review
6. Conclusions
Supplementary Materials
Author Contributions
Funding
Institutional Review Board Statement
Informed Consent Statement
Data Availability Statement
Acknowledgments
Conflicts of Interest
Abbreviations
95% CI | Confidence interval at 95% |
DOR | Diagnostic odd ratio |
FP | False positive |
FN | False negative |
JBI | Joanna Briggs Institute |
LDH | Lactate dehydrogenase |
LM | Light microscopy |
NLR | Negative likelihood ratio |
PDS | Panel detection score |
PfHRP2 | P. falciparum histidine rich protein 2 |
PLR | Positive likelihood ratio |
PRISMA | Preferred Reporting Items for Systematic Reviews and Meta-analyses |
RDTs | Rapid diagnostic tests |
Se | Sensitivity |
SEA | South East Asia |
sSA | sub-Saharan Africa |
SR-MA | Systematic review and meta-analysis |
Sp | Specificity |
TP | True positive |
TN | True negative |
WHO | World Health Organization |
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Types of Information | Nature of the Information Retrieved |
---|---|
Information on the Publication | Name of the first author or of the two authors Year of publication |
Information on study design, population, area | Study design Indian areas and Level of endemicity of area Year of data collection Population (adult, children and pregnant women) Clinical status of patients (febrile, asymptomatic) Type of malaria |
Diagnostic | Diagnostic methods used (LM, RDT, molecular methods) Staining molecule used in LM (Giemsa, Leishman, Jaswant Singh–Bhattacharji) Type, antigen, brand and manufacturer’s country of the RDTs Number of RDTs evaluated |
Performance parameters | Total number of individuals tested with different methods Total number of patients positive with gold standard and RDT Total number of P. vivax infections Number of mixed infections Number of false negative (FN), false positive (FP), true negative (TN) and true positive (TP) for diagnosis of P. falciparum, P. vivax and non-falciparum species. |
Brand | n | Manufacturer | Antigen Targeted | Categorisation as per WHO | PDS (%) at 200 Parasites/µL (Rounds 5–8) for Pfa and Pvb | FP and Invalid Result Rates | WHO Performance Criteria |
---|---|---|---|---|---|---|---|
ParaCheck Pf® | 12 | Orchid, Biomedical Systems, Goa, India | HRP2 | Pf only | 94.0a and NAb | NA and 0% | |
ParaSight F® | 10 | Becton Dickonson, Cockeys ville, MD, USA | HRP2 | Pf only | - | - | - |
ICT Malaria Pf™ | 10 | ICT Diagnostics, Brooksvale, NSW, USA | HRP2 | Pf only | - | - | - |
ParaHIT®-f | 9 | ARKRAY Healthcare Pvt. Ltd., Surat, India | HRP2 | Pf only | 77.0a and NAb | NA | |
DiaMed OptiMAL IT® | 6 | DiaMed AG, Cressier, Switzerland | PfLDH + Pan-LDH | Pf/Pan | - | - | - |
ICT Malaria Pf/Pv™ | 4 | ICT Diagnostics, Brooksvale, NSW, USA | Panmalarial Ag + HRP2 | Pf and Pv | 94.0a and NAb | NA | |
ParaHIT® Total | 4 | ARKRAY Healthcare Pvt. Ltd., Mumbai, India | Aldolase + Pan-LDH + HRP2 | Pf/Pan | - | - | - |
SD Bioline Pf/Pan® | 4 | SD Standard Diagnostics, Inc., South Korea | PfLDH + Pan-LDH | Pf/Pan | 94.0a and 91.4b | - | |
Determine™ Malaria Pf | 3 | Abbot Laboratories, Tokyo, Japan | HRP2 | Pf only | - | - | - |
Parascreen Device Pan/Pf® | 3 | Zephyr Biomedical, Verna, Goa, India | Pan-LDH + HRP2 | Pf/Pan | 91.0a and 91.4b | 0% and 0% | |
FalciVax™ (Pf/Pv) | 3 | Zephyr Biomedical, Verna, Goa, India | PvLDH + HRP2 | Pf and Pv/Pvom | 95.0a and 100b | 0.5% and 0% | |
First Response Combo Malaria Ag® | 3 | Premier medical corporation Ltd., India | Pan-LDH + HRP2 | Pf/Pan | 91.0-95.0a and NAb | 0% and 0% | |
SD Bioline Pf/Pv® | 3 | SD Standard Diagnostics, Inc., South Korea | PfLDH + PvLDH | Pf and Pv | 99.0a and 97.1b | 0% and 0% | |
Advantage Mal Card™ | 2 | J. Mitra & Co. Pvt. Ltd., Rajasthan, India | PfLDH + Pan-LDH | Pf/Pan | 30.0a and 94.3b | 0.4% and 0% | |
Alere™ Trueline Malaria Ag Pf/Pan | 1 | Alere Medical Pvt. Ltd., India | Pan-LDH + HRP2 | Pf/Pan | 85.0a and 91.4b | 0% and 0% | |
DiaMed OptiMAL® | 2 | Flow Inc., Portland, OR, USA | Pan-LDH | Pan only | - | - | - |
SD Bioline Pf® | 2 | SD Standard Diagnostics, Inc., South Korea | HRP2 | Pf only | 94.0a and NAb | NA and 0% | |
Malaria Pf (HRPII)/PV (PLDH) Antigen Detection Test Device™ | 1 | GENOMIX Molecular Diagnostics Pvt. Ltd., Hyderabad, Andhra Pradesh, India | PvLDH + HRP2 | Pf and Pv/Pvom | 85.0a and 74.3b | NA | |
Malarigen™ Pf/Pv test | 1 | Aspen Laboratories, India | Aldolase + Pan-LDH | NA | - | - | - |
Malarigen™ Pf/Pv test | 1 | Aspen Laboratories, India | Pan-LDH + HRP2 | NA | - | - | - |
Malarigen™ Pan test | 1 | Aspen Laboratories, India | Pan-LDH | NA | - | - | - |
Malascan Device Pf/Pan® | 1 | TulipScan Diagnostics, India | Aldolase + HRP2 | Pf/Pan | - | - | - |
NecVIPARUM™ One step Pf/Pv | 1 | Nectar Life Science Ltd., Chandigarh, India | PvLDH + HRP2 | Pf and Pv/Pvom | 88.0a and 91.4b | 0% and 4.5% | |
New™ Pf-1 mini | 1 | Monozyme India Ltd., Secundradad, India | HRP2 | Pf only | - | - | - |
DiaMed OptiMAL® 48 | 1 | DiaMed AG, Cressier, Switzerland | Pan-LDH | Pan only | - | - | - |
Standard Q™ Pf/Pv | 1 | SD Biosensor healthcare Pvt. Ltd., India | PvLDH + HRP2 | Pf and Pv/Pvom | 85.0a and 100b | 0% and 0.5 % | |
Not specified | 11 | - | - | - | - | - | - |
Total | 101§ |
RDT | Authors’ Findings | References as Seen in Table S4 | |
---|---|---|---|
Gametocyte detection versus RDT positivity | ICT Malaria Pf™ | Presence or absence of gametocytes was not related to RDT positivity | Valecha et al._1998 |
ICT Malaria Pf™ | Presence or absence of gametocytes was not related to RDT positivity | Ghosh et al._2000 | |
ParaCheck Pf® | No correlation between presence of falciparum gametocytes and RDT positivity | Ghosh et al._2002 | |
ParaCheck Pf® | Three individuals infected only with falciparum gametocytes were all RDT positive | Singh et al._2002 | |
ParaCheck Pf® | Two individuals infected only with falciparum gametocytes were all RDT negative | Arora et al._2003a | |
ParaSight F® | RDT failed to detect one individual with falciparum gametocytes only | Arora et al._2003b | |
DiaMed OptiMAL® | Two individuals infected only with falciparum gametocytes were all positive with the RDT | Singh et al._2003 | |
ParaCheck Pf® | P. falciparum gametocytes not detected or weakly detected by the RDT in all carriers | Gokhale et al._2004 | |
ParaHit®-f | 14 individuals infected with falciparum gametocytes were RDT positive | Singh et al._2005a | |
ParaCheck Pf® | Three only falciparum gametocytes -infected individuals were all RDT positive | Bhat Sandhya et al._2012 | |
Advantage mal Card™ | On day 8, falciparum gametocytes were detected by the RDT in all 9 patients | Kocharekar et al._2014 | |
Parasitemia versus Intensity band of RDT | ICT Malaria Pf™ | No correlation found | Valecha et al._1998 |
ICT Malaria Pf™ | No correlation found | Ghosh et al._2000 | |
ParaCheck Pf® | Positive correlation for development stage (Ring only, and Ring + gametocyte) | Ghosh et al._2002 |
WHO Performance Indicators& | ||||||
---|---|---|---|---|---|---|
RDTs | Antigen Targeted | PDS (%) | Positivity Rate (%) | FP Rate (%) | Invalid Rate (%) | Overall Evaluation |
SD Bioline Pf/Pan | PfLDH + Pan-LDH | 32.5 | 68.1 | NA | 0.0 | |
ParaCheck® F Pf | HRP2 | 15.0 | 40.5 | NA | 0.0 | |
Malarigen Pf/Pv | HRP2 + Pan-LDH | 32.5 | 43.1 | 0.0 | 0.0 | |
FalciVax (Pf/Pv) | HRP2 + Pv-LDH | 0.0 | 3.1 | 0.0 | 0.0 | |
First Response® Combo Malaria Ag | HRP2 + Pan-LDH | 12.5 | 23.1 | 0.0 | 0.0 | |
NecVIPARUM One step Pf/Pv | HRP2 + Pv-LDH | 32.5 | 45.9 | 0.6 | 0.6 | |
Parascreen Device Pan/Pf | HRP2 + Pan-LDH | 0.0 | 0.6 | 50.6 | 0.0 |
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Kojom Foko, L.P.; Pande, V.; Singh, V. Field Performances of Rapid Diagnostic Tests Detecting Human Plasmodium Species: A Systematic Review and Meta-Analysis in India, 1990–2020. Diagnostics 2021, 11, 590. https://doi.org/10.3390/diagnostics11040590
Kojom Foko LP, Pande V, Singh V. Field Performances of Rapid Diagnostic Tests Detecting Human Plasmodium Species: A Systematic Review and Meta-Analysis in India, 1990–2020. Diagnostics. 2021; 11(4):590. https://doi.org/10.3390/diagnostics11040590
Chicago/Turabian StyleKojom Foko, Loick Pradel, Veena Pande, and Vineeta Singh. 2021. "Field Performances of Rapid Diagnostic Tests Detecting Human Plasmodium Species: A Systematic Review and Meta-Analysis in India, 1990–2020" Diagnostics 11, no. 4: 590. https://doi.org/10.3390/diagnostics11040590