Evaluation of the Diagnostic Accuracy of CareStart G6PD Deficiency Rapid Diagnostic Test (RDT) in a Malaria Endemic Area in Ghana, Africa

Abstract Previous studies have shown that the CareStart™ G6PD Deficiency rapid diagnostic test has high diagnostic accuracy on G6PD deficiency in Africa and Thailand, but not in China. As there are regional differences of G6PD genotype distribution, we are attending to verify the effectiveness of the kit in Chinese population. The study cohort included 247 newborns admitted to our hospital for jaundice. The quantitative detection of G6PD enzyme activity and G6PD gene mutations analysis was used to classify the status of G6PD deficiency. The performance of CareStart™ assays was verified by calculating the sensitivity, specificity and area under the receiver operating characteristic curve (AUC) based on the corrected G6PD deficiency status. In male newborns, the sensitivity of the CareStart™ assay was 98.9%, the specificity was 94.2% and the AUC was 0.97. In female newborns, the sensitivity was 58.5% when the cutoff value of residual enzyme activity was 100%; however, the sensitivity was 100% when the cutoff value was 60%. Therefore, the CareStart™ test can effectively screen G6PD deficiency in male newborns and female infants with less than 60% residual enzyme activity, female infants with residual enzyme activities of 60–100% are more likely to be missed diagnosed among Chinese newborns.

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A Phase III Diagnostic Accuracy Study of a Rapid Diagnostic Test for Diagnosis of Second-Stage Human African Trypanosomiasis in the Democratic Republic of the Congo

EBioMedicine ◽

10.1016/j.ebiom.2017.10.032 ◽

2018 ◽

Vol 27 ◽

pp. 11-17 ◽

Cited By ~ 10

Author(s):

Marleen Boelaert ◽

Deby Mukendi ◽

Emmanuel Bottieau ◽

Jean Roger Kalo Lilo ◽

Kristien Verdonck ◽

...

Keyword(s):

Diagnostic Accuracy ◽

Diagnostic Test ◽

Rapid Diagnostic Test ◽

Human African Trypanosomiasis ◽

Democratic Republic ◽

Phase Iii ◽

Diagnostic Accuracy Study ◽

Second Stage ◽

Republic Of The Congo ◽

Accuracy Study

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Rapid diagnostic test for G6PD deficiency in Plasmodium vivax -infected men: a budget impact analysis based in Brazilian Amazon

Tropical Medicine & International Health ◽

10.1111/tmi.12800 ◽

2016 ◽

Vol 22 (1) ◽

pp. 21-31

Author(s):

Henry Maia Peixoto ◽

Marcelo Augusto Mota Brito ◽

Gustavo Adolfo Sierra Romero ◽

Wuelton Marcelo Monteiro ◽

Marcus Vinícius Guimarães de Lacerda ◽

...

Keyword(s):

Plasmodium Vivax ◽

Diagnostic Test ◽

Rapid Diagnostic Test ◽

G6pd Deficiency ◽

Impact Analysis ◽

Budget Impact ◽

Brazilian Amazon ◽

Budget Impact Analysis

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Malarial Fever Diagnosed and Treated in a Low Risk Endemic Area

Journal of Karnali Academy of Health Sciences ◽

10.3126/jkahs.v1i2.24141 ◽

2018 ◽

Vol 1 (2) ◽

pp. 56-58

Author(s):

Dharma Raj Regmi ◽

N. Basnet ◽

C. Jaishwal ◽

S. Pun

Keyword(s):

Diagnostic Test ◽

Rapid Diagnostic Test ◽

Hospital Pharmacy ◽

Endemic Area ◽

Female Child ◽

Low Risk ◽

Oral Antibiotics ◽

Febrile Patient ◽

Risk Area ◽

High Degree

A case of a 2-year-old female child who initially presented with fever, later diagnosed and successfully treated as Malaria in Jajarkot Hospital in the District of Jajarkot which is a low malarial prevalence region. Patient had been treated with oral antibiotics in a local out of hospital pharmacy but continued to remain febrile. Patient admitted for evaluation of fever and inability to feed. Malaria was confirmed with ICT based Rapid Diagnostic Test after other foci/infection with high degree of suspicion were ruled out. Patient was treated based on the recent national guideline and eventually discharged after showing significant signs of improvement. This isolated case of malaria in a hilly low risk area like Jajarkot emphasizes the need to remain vigilant and adopt a stringent protocol-based diagnostic for diagnosis and treatment of a febrile patient.

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Submicroscopic carriage of Plasmodium falciparum and Plasmodium vivax in a low endemic area in Ethiopia where no parasitaemia was detected by microscopy or rapid diagnostic test

Malaria Journal ◽

10.1186/s12936-015-0821-1 ◽

2015 ◽

Vol 14 (1) ◽

Cited By ~ 35

Author(s):

Fitsum G Tadesse ◽

Helmi Pett ◽

Amrish Baidjoe ◽

Kjerstin Lanke ◽

Lynn Grignard ◽

...

Keyword(s):

Plasmodium Falciparum ◽

Plasmodium Vivax ◽

Diagnostic Test ◽

Rapid Diagnostic Test ◽

Endemic Area

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Diagnostic Accuracy of Clinical Symptoms and Rapid Diagnostic Test in Group A Streptococcal Perianal Infections in Children

Clinical Infectious Diseases ◽

10.1093/cid/ciu794 ◽

2014 ◽

Vol 60 (2) ◽

pp. 267-270 ◽

Cited By ~ 11

Author(s):

R. Cohen ◽

C. Levy ◽

S. Bonacorsi ◽

A. Wollner ◽

M. Koskas ◽

...

Keyword(s):

Diagnostic Accuracy ◽

Diagnostic Test ◽

Rapid Diagnostic Test ◽

Clinical Symptoms ◽

Group A

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Diagnostic Accuracy of Antibody-based Rapid Diagnostic Test in Detecting Coronavirus Disease 2019: Systematic Review

Archives of Medical Science ◽

10.5114/aoms/135910 ◽

2021 ◽

Author(s):

Yanto Tjang ◽

Tiara Gracienta ◽

Ryan Herardi ◽

Frans Santosa ◽

Taufiq Pasiak

Keyword(s):

Systematic Review ◽

Diagnostic Accuracy ◽

Diagnostic Test ◽

Rapid Diagnostic Test ◽

Predictive Value ◽

Detection Method ◽

Target Antigen ◽

Test Accuracy ◽

Eligibility Criteria ◽

Sensitivity Specificity

IntroductionThe rapid transmission of Coronavirus disease 2019 (COVID-19) requires a fast, accurate, and affordable detection method. Despite doubts of its diagnostic accuracy, Rapid Diagnostic Test (RDT) is world-widely used in consideration for its practicality. This systematic review aims to determine the diagnostic accuracy of antibody-based RDT in detecting COVID-19.Material and methodsA literature search was carried out on five journal databases using the PRISMA-P 2015 method. We included all studies published up to February 2021. The risk of bias was evaluated using The Joanna Briggs Institute (JBI) Critical Appraisal Checklist for Diagnostic Test Accuracy Studies. Data regarding peer-review status, study design, tests kit information, immunoglobulin class, target antigen, and the number of samples were extracted and tabulated. We estimated the pooled sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) with a 95% confidence interval.ResultsThirty-three studies met the eligibility criteria. The pooled data results showed that the combined detection method of IgM or IgG had the highest sensitivity and NPV, which were 73.41% (95% CI: 72.22-74.57) and 75.34% (95% CI: 74.51-76.16), respectively. The single IgG detection method had the highest specificity and PPV of 96.68% (95% CI: 96.25-97.07) and 95.97% (95% CI: 95.47-96.42%), respectively.ConclusionsAntibody-based RDT is not satisfactory as a primary diagnostic test but has utilities as a screening tool.

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