Skip to main content
  • ASM
    • Antimicrobial Agents and Chemotherapy
    • Applied and Environmental Microbiology
    • Clinical Microbiology Reviews
    • Clinical and Vaccine Immunology
    • EcoSal Plus
    • Eukaryotic Cell
    • Infection and Immunity
    • Journal of Bacteriology
    • Journal of Clinical Microbiology
    • Journal of Microbiology & Biology Education
    • Journal of Virology
    • mBio
    • Microbiology and Molecular Biology Reviews
    • Microbiology Resource Announcements
    • Microbiology Spectrum
    • Molecular and Cellular Biology
    • mSphere
    • mSystems
  • Log in
  • My alerts
  • My Cart

Main menu

  • Home
  • Articles
    • Current Issue
    • Accepted Manuscripts
    • COVID-19 Special Collection
    • Archive
    • Minireviews
  • For Authors
    • Submit a Manuscript
    • Scope
    • Editorial Policy
    • Submission, Review, & Publication Processes
    • Organization and Format
    • Errata, Author Corrections, Retractions
    • Illustrations and Tables
    • Nomenclature
    • Abbreviations and Conventions
    • Publication Fees
    • Ethics Resources and Policies
  • About the Journal
    • About JCM
    • Editor in Chief
    • Editorial Board
    • For Reviewers
    • For the Media
    • For Librarians
    • For Advertisers
    • Alerts
    • RSS
    • FAQ
  • Subscribe
    • Members
    • Institutions
  • ASM
    • Antimicrobial Agents and Chemotherapy
    • Applied and Environmental Microbiology
    • Clinical Microbiology Reviews
    • Clinical and Vaccine Immunology
    • EcoSal Plus
    • Eukaryotic Cell
    • Infection and Immunity
    • Journal of Bacteriology
    • Journal of Clinical Microbiology
    • Journal of Microbiology & Biology Education
    • Journal of Virology
    • mBio
    • Microbiology and Molecular Biology Reviews
    • Microbiology Resource Announcements
    • Microbiology Spectrum
    • Molecular and Cellular Biology
    • mSphere
    • mSystems

User menu

  • Log in
  • My alerts
  • My Cart

Search

  • Advanced search
Journal of Clinical Microbiology
publisher-logosite-logo

Advanced Search

  • Home
  • Articles
    • Current Issue
    • Accepted Manuscripts
    • COVID-19 Special Collection
    • Archive
    • Minireviews
  • For Authors
    • Submit a Manuscript
    • Scope
    • Editorial Policy
    • Submission, Review, & Publication Processes
    • Organization and Format
    • Errata, Author Corrections, Retractions
    • Illustrations and Tables
    • Nomenclature
    • Abbreviations and Conventions
    • Publication Fees
    • Ethics Resources and Policies
  • About the Journal
    • About JCM
    • Editor in Chief
    • Editorial Board
    • For Reviewers
    • For the Media
    • For Librarians
    • For Advertisers
    • Alerts
    • RSS
    • FAQ
  • Subscribe
    • Members
    • Institutions
Parasitology

Multicenter Pivotal Clinical Trial of Urine Malaria Test for Rapid Diagnosis of Plasmodium falciparum Malaria

Wellington A. Oyibo, Nnenna Ezeigwe, Godwin Ntadom, Oladipo O. Oladosu, Kaitlin Rainwater-Loveth, Wendy O'Meara, Evaezi Okpokoro, William Brieger
Peter Gilligan, Editor
Wellington A. Oyibo
aANDI Centre of Excellence for Malaria Diagnosis, International Malaria Microscopy Training and Rapid Diagnostic Test Quality Assurance Programme, and WHO/TDR/FIND Malaria Specimen Bank Site, College of Medicine, University of Lagos, Lagos, Nigeria
  • Find this author on Google Scholar
  • Find this author on PubMed
  • Search for this author on this site
Nnenna Ezeigwe
bNational Malaria Elimination Program, Federal Ministry of Health, Abuja, Nigeria
  • Find this author on Google Scholar
  • Find this author on PubMed
  • Search for this author on this site
Godwin Ntadom
bNational Malaria Elimination Program, Federal Ministry of Health, Abuja, Nigeria
  • Find this author on Google Scholar
  • Find this author on PubMed
  • Search for this author on this site
Oladipo O. Oladosu
aANDI Centre of Excellence for Malaria Diagnosis, International Malaria Microscopy Training and Rapid Diagnostic Test Quality Assurance Programme, and WHO/TDR/FIND Malaria Specimen Bank Site, College of Medicine, University of Lagos, Lagos, Nigeria
  • Find this author on Google Scholar
  • Find this author on PubMed
  • Search for this author on this site
Kaitlin Rainwater-Loveth
cJohns Hopkins University School of Public Health, Baltimore, Maryland, USA
  • Find this author on Google Scholar
  • Find this author on PubMed
  • Search for this author on this site
Wendy O'Meara
dDuke University School of Medicine, Durham, North Carolina, USA
  • Find this author on Google Scholar
  • Find this author on PubMed
  • Search for this author on this site
Evaezi Okpokoro
eInstitute of Human Virology Nigeria, Abuja, Nigeria
  • Find this author on Google Scholar
  • Find this author on PubMed
  • Search for this author on this site
William Brieger
cJohns Hopkins University School of Public Health, Baltimore, Maryland, USA
  • Find this author on Google Scholar
  • Find this author on PubMed
  • Search for this author on this site
Peter Gilligan
UNC Health Care System
Roles: Editor
  • Find this author on Google Scholar
  • Find this author on PubMed
  • Search for this author on this site
DOI: 10.1128/JCM.01431-16
  • Article
  • Figures & Data
  • Info & Metrics
  • PDF
Loading

Article Figures & Data

Figures

  • Tables
  • FIG 1
    • Open in new tab
    • Download powerpoint
    FIG 1

    Pooled ROC curves of the study participants (combined febrile and afebrile) tested with the urine malaria test and BinaxNOW Pf and BinaxNOW Pan. AUC, area under the curve. P values comparing the area under the receiver-operator characteristic (ROC) curves were computed using DeLong's test for two ROC curves.

Tables

  • Figures
  • TABLE 1

    Demographic characteristics and clinical history of the study population

    ParameterNo. of patients (%)
    Overall (n = 1,691)Febrile (n = 566)Afebrile (n = 1,125)
    Gender
        Female970 (57)276 (49)694 (62)
        Male721 (43)290 (51)431 (38)
    Age (yr)
        2–5416 (25)202 (36)214 (19)
        6–11390 (23)175 (31)215 (19)
        12–17195 (12)81 (14)114 (10)
        18–2061 (4)20 (4)41 (4)
        21–39427 (25)71 (13)356 (32)
        40–54153 (9)13 (2)140 (12)
        55+49 (3)4 (1)45 (4)
    Symptoms
        Chills1,135 (67)442 (78)693 (62)
        Body pain1,159 (69)387 (68)772 (69)
        Headache1,364 (81)473 (84)891 (69)
        Vomiting257 (15)129 (23)128 (11)
        Stomach ache185 (11)128 (23)57 (5)
        Weakness68 (4)56 (10)12 (1)
        Anorexia186 (11)86 (15)100 (9)
        Cough189 (11)117 (21)72 (6)
        Catarrh170 (10)107 (19)63 (6)
        Bitter taste31 (2)25 (4)6 (1)
        Dizziness46 (3)35 (6)11 (1)
        Other83 (5)25 (4)58 (5)
    Study site
        Agura365 (22)75 (13)290 (26)
        Bayekun218 (13)88 (16)130 (12)
        Ijede522 (31)206 (36)316 (28)
        Imota439 (26)164 (29)275 (24)
        Oreta48 (3)6 (1)42 (4)
        Shomolu99 (6)27 (5)72 (6)
    • a The mean age ± SD for each group was as follows: overall, 18.6 ± 15.9 years (range, 2.0 to 80 years); febrile, 11.6 ± 11.0 years (range, 2.0 to 70 years); afebrile, 22.1 ± 16.7 years (range, 2.0 to 80 years).

  • TABLE 2

    Malaria microscopy, UMT, blood-based malaria RDT (BinaxNow Pf/Pan), and urinalysis results of the study population

    ParameterNo. of patients (%)b
    Overall (n = 1,691)Febrile (n = 566)Afebrile (n = 1,125)
    Positive malaria diagnostic tests
        Microscopy341 (20.2)204 (36)137 (12.2)
        UMT419 (25)231 (41)188 (17)
        BinaxNOW Pf676 (40)315 (56)361 (32)
        BinaxNOW Pan368 (22)224 (40)144 (13)
    Parasite prevalence
        Detectable asexual stage parasites338 (20)203 (36)155 (14)
        Density (no. of parasites)a
            1–1992 (1)1 (0.5)1 (1)
            200–49916 (5)5 (2)11 (7)
            500–99920 (6)8 (4)12 (8)
            1,000–4 99970 (21)34 (17)36 (23)
            5,000–9 99944 (13)26 (13)18 (12)
            10,000–49 999109 (32)75 (37)34 (22)
            50,000+77 (23)54 (27)23 (15)
    Urinalysis
        Leukocytes >15/µl189 (11)67 (12)182 (16)
        Presence of nitrites (mg/dl)22 (1)7 (1)15 (1)
        Urobilinogen of ≥1 mg/dl159 (9)67 (12)92 (8)
        Protein of >100 mg/dl73 (4)42 (7)31 (3)
        Ketone of >5 mg/dl344 (20)176 (31)168 (15)
        Bilirubin of ≥1 mg/dl159 (9)71 (13)88 (8)
        Glucose (mg/dl)21 (1)5 (1)16 (1)
        Blood (erythrocytes/µl)175 (10)77 (14)98 (9)
        pH
            <71,443 (85)493 (87)950 (84)
            7114 (7)45 (8)69 (6)
            >7130 (8)27 (5)103 (9)
        Specific gravity
             <1.010549 (32)158 (28)391 (35)
            1.011–1.020725 (43)264 (47)461 (41)
            >1.021414 (24)144 (25)270 (24)
    • ↵a Asexual parasite stage only.

    • ↵b Percentages in subcategories of parasite density were calculated as number of patients in the density subcategory/total number of patients with detectable asexual parasites.

  • TABLE 3

    Performance of urine malaria test and blood-based RDTs in overall study participants and febrile and afebrile subjects at clinical presentation

    Group and parameteraTest performancebP valuec
    UMTBinaxNOW PfBinaxNOW PanUMT vs BinaxNOW PfUMT vs BinaxNOW Pan
    All participants (n = 1,691)
        Sensitivity (% [95% CI])79 (75, 84)98 (96, 99)80 (76, 84)<0.0010.824
        Specificity (% [95% CI])89 (87, 91)75 (72, 77)93 (92, 94)<0.001<0.001
        PPV (% [95% CI])65 (60, 69)50 (46, 53)74 (70, 79)1.000.988
        NPV (% [95% CI])94 (93, 96)99 (99, 100)95 (94, 96)0.9321.00
        NLR0.23 (0.23, 0.24)0.02 (0.02, 0.03)0.21 (0.21, 0.22)
        PLR7.2 (7.2, 7.3)3.9 (3.9, 3.9)11.5 (11.3, 11.8)
    Febrile participants (n = 566)
        Sensitivity (% [95% CI])85 (79, 89)99 (97, 100)86 (80, 90)<0.0010.883
        Specificity (% [95% CI])84 (80, 88)69 (64, 74)86 (83, 90)<0.0010.176
        PPV (% [95% CI])75 (69, 80)64 (59, 69)78 (72, 83)1.000.981
        NPV (% [95% CI])91 (87, 94)99 (97, 100)92 (88, 94)0.6930.808
        NLR0.18 (0.17, 0.19)0.01 (0.01, 0.04)0.16 (0.16, 0.17)
        PLR5.3 (5.1, 5.5)3.2 (3.1, 3.2)6.3 (6.1, 6.6)
    Afebrile participants (n = 1,125)
        Sensitivity (% [95% CI])72 (63, 79)97 (93, 99)72 (64, 80)<0.0011.00
        Specificity (% [95% CI])91 (89, 93)77 (74, 80)95 (94, 97)<0.001<0.001
        PPV (% [95% CI])52 (45, 59)37 (32, 42)69 (61, 76)1.000.981
        NPV (% [95% CI])96 (94, 97)99 (99, 100)96 (95, 97)0.9381.00
        NLR0.31 (0.30, 0.32)0.04 (0.02, 0.06)0.29 (0.28, 0.30)
        PLR7.9 (7.7, 8.1)4.2 (4.2, 4.2)15.9 (15.1, 16.6)
    • ↵a PPV, positive predictive value; NPV, negative predictive value; NLR, negative likelihood ratio; PLR, positive likelihood ratio.

    • ↵b BinaxNOW Pf contains HRP-2, a P. falciparum-specific antigen, and BinaxNOW Pan contains aldolase, an antigen found in all species of Plasmodium. P. falciparum is the most dominant species in the trial area.

    • ↵c P values comparing the sensitivities and specificities of the Fyodor UMT and the BinaxNOW tests were estimated using McNemar's test. P values comparing the positive and negative predictive values were calculated using the weighted generalized score statistic.

  • TABLE 4

    Area under the ROC curve for all tests stratified by presence of fever

    TestAUC (95% CI)P valuea
    FebrileAfebrile
    UMT0.84 (0.81, 0.88)0.81 (0.78, 0.84)0.212
    BinaxNOW Pf0.84 (0.81, 0.87)0.87 (0.85, 0.89)0.054
    BinaxNOW Pan0.86 (0.83, 0.89)0.84 (0.81, 0.87)0.358
    • ↵a P values comparing the area under the receiver-operator characteristic (ROC) curves were computed using DeLong's test for two ROC curves.

  • TABLE 5

    Sensitivity and specificity of UMT, BinaxNOW Pf, and BinaxNOW Pan tests by parasite density level for febrile, afebrile, and all study participants

    Group and testTest performance by parasite densityaP value by density groupb
    Specificity (% [CI]) at 0Sensitivity (% [CI])
    1–9991,000–4,9995,000+1–9991,000–4,999
    Total study population
        UMT89 (87, 91)58 (41, 74)69 (56, 79)86 (81, 90)<0.0010.002
        BinaxNOW Pf75 (72, 77)95 (82, 99)96 (88, 99)100 (98, 100)0.0550.042
        BinaxNOW Pan93 (92, 94)42 (26, 59)70 (58, 80)90 (85, 93)<0.001<0.001
    Febrile group
        UMT84 (80, 88)71 (42, 92)76 (59, 89)88 (81, 92)0.1050.107
        BinaxNOW Pf69 (64, 74)93 (66, 100)97 (85, 100)NA0.0830.181
        BinaxNOW Pan86 (83, 90)57 (29, 82)79 (62, 91)NA0.0040.143
    Afebrile group
        UMT91 (89, 93)50 (29, 71)61 (43, 77)82 (71, 90)<0.0010.020
        BinaxNOW Pf77 (74, 80)96 (79, 100)94 (81, 99)99 (93, 100)0.0550.253
        BinaxNOW Pan95 (94, 97)33 (16, 55)61 (43, 77)90 (81, 96)<0.0010.001
    • ↵a Parasite density (number of parasites/microliter of blood) was determined by microscopy. NA, not available.

    • ↵b P values are based on a comparison with the results from the 5,000+ density group using Fisher's exact test.

  • TABLE 6

    Urine malaria test (UMT) performance characteristics among study participants infected with Plasmodium falciparum relative to original and PCR-corrected microscopy results

    Parameter and groupaUMT performance relative to:P valueb
    Original microscopyPCR-corrected microscopy
    Sensitivity (% [CI])
        All participants78 (74, 83)77 (72, 81)0.665
        Febrile85 (79, 89)81 (75, 86)0.577
        Afebrile72 (64, 79)72 (66, 79)1.00
    Specificity (% [CI])
        All participants90 (89, 91)92 (90, 93)0.368
        Febrile84 (80, 88)85 (81, 89)0.770
        Afebrile92 (90, 93)94 (92, 95)0.091
    PPV (% [CI])
        All participants63 (58, 67)70 (65, 74)1.00
        Febrile74 (68, 80)77 (71, 82)1.00
        Afebrile51 (44, 57)63 (56, 69)1.00
    NPV (% [CI])
        All participants95 (94, 96)94 (93, 95)0.945
        Febrile90 (87, 93)88 (84, 91)0.891
        Afebrile97 (95, 97)96 (95, 97)0.941
    PLR
        All participants0.240 (0.237, 0.243)0.253 (0.249, 0.256)
        Febrile0.201 (0.195, 0.207)0.228 (0.221, 0.236)
        Afebrile0.304 (0.298, 0.311)0.294 (0.287, 0.302)
    NLR
        All participants7.87 (7.72, 8.03)9.25 (9.11, 9.40)
        Febrile5.29 (5.04, 5.55)5.49 (5.29, 5.70)
        Afebrile8.70 (8.42, 8.99)11.2 (10.9, 11.5)
    • ↵a PPV, positive predictive value; NPV, negative predictive value; PLR, positive likelihood ratio; NLR, negative likelihood ratio.

    • ↵b P values were estimated by the chi-square statistic for sensitivity and specificity and by the weighted generalized score method for predictive values.

PreviousNext
Back to top
Download PDF
Citation Tools
Multicenter Pivotal Clinical Trial of Urine Malaria Test for Rapid Diagnosis of Plasmodium falciparum Malaria
Wellington A. Oyibo, Nnenna Ezeigwe, Godwin Ntadom, Oladipo O. Oladosu, Kaitlin Rainwater-Loveth, Wendy O'Meara, Evaezi Okpokoro, William Brieger
Journal of Clinical Microbiology Dec 2016, 55 (1) 253-263; DOI: 10.1128/JCM.01431-16

Citation Manager Formats

  • BibTeX
  • Bookends
  • EasyBib
  • EndNote (tagged)
  • EndNote 8 (xml)
  • Medlars
  • Mendeley
  • Papers
  • RefWorks Tagged
  • Ref Manager
  • RIS
  • Zotero
Print

Alerts
Sign In to Email Alerts with your Email Address
Email

Thank you for sharing this Journal of Clinical Microbiology article.

NOTE: We request your email address only to inform the recipient that it was you who recommended this article, and that it is not junk mail. We do not retain these email addresses.

Enter multiple addresses on separate lines or separate them with commas.
Multicenter Pivotal Clinical Trial of Urine Malaria Test for Rapid Diagnosis of Plasmodium falciparum Malaria
(Your Name) has forwarded a page to you from Journal of Clinical Microbiology
(Your Name) thought you would be interested in this article in Journal of Clinical Microbiology.
CAPTCHA
This question is for testing whether or not you are a human visitor and to prevent automated spam submissions.
Share
Multicenter Pivotal Clinical Trial of Urine Malaria Test for Rapid Diagnosis of Plasmodium falciparum Malaria
Wellington A. Oyibo, Nnenna Ezeigwe, Godwin Ntadom, Oladipo O. Oladosu, Kaitlin Rainwater-Loveth, Wendy O'Meara, Evaezi Okpokoro, William Brieger
Journal of Clinical Microbiology Dec 2016, 55 (1) 253-263; DOI: 10.1128/JCM.01431-16
del.icio.us logo Digg logo Reddit logo Twitter logo CiteULike logo Facebook logo Google logo Mendeley logo
  • Top
  • Article
    • ABSTRACT
    • INTRODUCTION
    • RESULTS
    • DISCUSSION
    • MATERIALS AND METHODS
    • ACKNOWLEDGMENTS
    • FOOTNOTES
    • REFERENCES
  • Figures & Data
  • Info & Metrics
  • PDF

KEYWORDS

Antigens, Protozoan
Chromatography, Affinity
Malaria, Falciparum
Point-of-Care Systems
health care provider
malaria
noninvasive malaria test
Plasmodium falciparum
point-of-care diagnosis
primary healthcare setting
rapid diagnostic test (RDT)
urine malaria test (UMT)

Related Articles

Cited By...

About

  • About JCM
  • Editor in Chief
  • Board of Editors
  • Editor Conflicts of Interest
  • For Reviewers
  • For the Media
  • For Librarians
  • For Advertisers
  • Alerts
  • RSS
  • FAQ
  • Permissions
  • Journal Announcements

Authors

  • ASM Author Center
  • Submit a Manuscript
  • Article Types
  • Resources for Clinical Microbiologists
  • Ethics
  • Contact Us

Follow #JClinMicro

@ASMicrobiology

       

ASM Journals

ASM journals are the most prominent publications in the field, delivering up-to-date and authoritative coverage of both basic and clinical microbiology.

About ASM | Contact Us | Press Room

 

ASM is a member of

Scientific Society Publisher Alliance

 

American Society for Microbiology
1752 N St. NW
Washington, DC 20036
Phone: (202) 737-3600

 

Copyright © 2021 American Society for Microbiology | Privacy Policy | Website feedback

Print ISSN: 0095-1137; Online ISSN: 1098-660X