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Cited by 38Malaria Research and ControlBiosensors and Analytical DetectionClinical Laboratory Practices and Quality Control

Performance of four HRP-2/pLDH combination rapid diagnostic tests and field microscopy as screening tests for malaria in pregnancy in Indonesia: A cross-sectional study

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Ahmed, Rukhsana, Levy, Elvira I., Maratina, Sylvia S., de Jong, Judith J., Asih, Puji B. S., Rozi, Ismail E., Hawley, William, Syafruddin, Din +1 more·2015·Malaria Journal
DOI 10.1186/s12936-015-0943-5PMC PMC4625567
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Abstract

BACKGROUND: Malaria in pregnancy poses a major public health problem in Indonesia with an estimated six million pregnancies at risk of Plasmodium falciparum or Plasmodium vivax malaria annually. In 2010, Indonesia introduced a screen and treat policy for the control of malaria in pregnancy at first antenatal visit using microscopy or rapid diagnostic tests (RDTs). A diagnostic study was conducted in Sumba, Indonesia to compare the performance of four different RDTs in predominately asymptomatic pregnant women under field condition. METHODS: Women were screened for malaria at antenatal visits using field microscopy and four HRP-2/pLDH combination RDTs (Carestart™, First-Response(®), Parascreen(®) and SD-Bioline(®)). The test results were compared with expert microscopy and nested PCR. End user experience of the RDTs in the field was assessed by questionnaire. RESULTS: Overall 950 were recruited and 98.7 % were asymptomatic. The prevalence of malaria was 3.0-3.4 % by RDTs, and 3.6, 5.0 and 6.6 % by field microscopy, expert microscopy and PCR, respectively. The geometric-mean parasite density was low (P. falciparum = 418, P. vivax = 147 parasites/µL). Compared with PCR, the overall sensitivity of the RDTs and field microscopy to detect any species was 24.6-31.1 %; specificities were >98.4 %. Relative to PCR, First-Response(®) had the best diagnostic accuracy (any species): sensitivity = 31.1 %, specificity = 98.9 % and diagnostic odds ratio = 39.0 (DOR). The DOR values for Carestart™, Parascreen(®), SD-Bioline(®), and field microscopy were 23.4, 23.7, 23.5 and 29.2, respectively. The sensitivity of Pan-pLDH bands to detect PCR confirmed P. vivax mono-infection were 8.6-13.0 %. The sensitivity of the HRP-2 band alone to detect PCR confirmed P. falciparum was 10.3-17.9 %. Pan-pLDH detected P. falciparum cases undetected by the HRP-2 band resulting in a better test performance when both bands were combined. First Response(®) was preferred by end-users for the overall practicality. CONCLUSION: The diagnostic accuracy to detect malaria among mostly asymptomatic pregnant women and perceived ease of use was slightly better with First-Response(®), but overall, differences between the four RDTs were small and performance comparable to field microscopy. Combination RDTs are a suitable alternative to field microscopy to screen for malaria in pregnancy in rural Indonesia. The clinical relevance of low density malaria infections detected by PCR, but undetected by RDTs or microscopy needs to be determined.

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Authors
Ahmed, R., Levy, E. I., Maratina, S. S., de Jong, J. J., Asih, P. B. S., Rozi, I. E., Hawley, W., Syafruddin, D., & ter Kuile, F.
Affiliations
  • Liverpool School of Tropical Medicine (GB)
  • Amsterdam UMC Location University of Amsterdam (NL)
  • Eijkman Institute for Molecular Biology (ID)
  • United Nations Children's Fund (US)
Corresponding author
Ahmed, Rukhsana
ORCID
Venue
Malaria Journal
Publisher
Springer Science and Business Media LLC
Published
2015-10-29
Volume
14
Issue
1
Pages
420-420
ISSN
1475-2875 (ISSN-L)
DOI
10.1186/s12936-015-0943-5
PMC
PMC4625567
OpenAlex
W1883406424
Cited by
38
References
38
Citations by year
2025: 4 · 2024: 2 · 2023: 4 · 2022: 5 · 2021: 3 · 2020: 4 · 2019: 1 · 2018: 9 · 2017: 3 · 2016: 3
FWCI
5.34
Type
journal article
Language
en
Open access
Licence
cc-by
Locations
  • Malaria Journal (publishedVersion, cc-by)
  • PubMed Central (publishedVersion, cc-by)
  • PubMed (publishedVersion)
  • LSTM Online Archive (Liverpool School of Tropical Medicine) (acceptedVersion)
  • Data Archiving and Networked Services (DANS) (submittedVersion)
Funders
UNICEF, Indonesia (SSA/IDSA/2011/00002000-1)
Topics
  • Health Sciences › Medicine › Public Health, Environmental and Occupational Health › Malaria Research and Control
  • Physical Sciences › Engineering › Biomedical Engineering › Biosensors and Analytical Detection
  • Health Sciences › Medicine › Physiology › Clinical Laboratory Practices and Quality Control
Keywords
malaria in pregnancy, rapid diagnostic tests, Plasmodium falciparum, Plasmodium vivax, diagnostic accuracy, asymptomatic malaria, prenatal screening, nested PCR, Sumba, Indonesia, malaria control policy, end-user experience, parasite density
MeSH terms
Adolescent, Adult, Antigens, Protozoan, Chromatography, Affinity, Cross-Sectional Studies, Diagnostic Tests, Routine, Female, Humans, Indonesia, Mass Screening, Microscopy, Middle Aged, Plasmodium falciparum, Plasmodium vivax, Pregnancy, Pregnancy Complications, Infectious, Polymerase Chain Reaction, Malaria, Falciparum, Malaria, Vivax, Young Adult

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