Malaria Rapid Diagnostic Devices: Performance Characteristics of the
            <i>Para</i>
            Sight F Device Determined in a Multisite Field Study

Forney, John R.; Magill, Alan J.; Wongsrichanalai, Chansuda; Sirichaisinthop, Jeeraphat; Bautista, Christian T.; Heppner, D. Gray; Miller, R. Scott; Ockenhouse, Christian F.; Gubanov, Alex; Shafer, Robyn; DeWitt, Caroline C.; Quino-Ascurra, Higinio A.; Kester, Kent E.; Kain, Kevin C.; Walsh, Douglas S.; Ballou, W. Ripley; Gasser, Robert A.

doi:10.1128/jcm.39.8.2884-2890.2001

Cited by 54 publications

(48 citation statements)

References 26 publications

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“…The extensive quality assurance procedures are described by Forney et al (2001). WBC counts had skewed distributions, as expected (Bain, 2002).…”

Section: Methodsmentioning

confidence: 99%

“…The extensive quality assurance procedures are described by Forney et al (2001). WBC counts had skewed distributions, as expected (Bain, 2002 The 1,043 P. vivax and 1,098 P. falciparum cases analyzed here exclude 3,745 cases for whom the 2 microscopists agreed on the absence of blood stage Plasmodium spp., 482 for whom they disagreed on the presence or species of asexual parasites or the presence of gametocytes, 80 for whom one or both reported a mixed-species infection, and 9 with gametocyte-only infections (4 P. vivax and 5 P. falciparum).…”

Section: Nih-pa Author Manuscriptmentioning

confidence: 99%

“…Data were collected during studies of malaria rapid diagnostic devices, for which the methods are fully described elsewhere (Forney et al, 2001(Forney et al, , 2003McKenzie et al, 2003McKenzie et al, , 2005McKenzie et al, , 2006Erhart et al, 2004;O'Meara et al, 2005). Briefly, participants presented on their own initiative to existing outpatient malaria clinics operated by local public health authorities at Maesod, Tak Province, Thailand, or Iquitos, Peru, 28 May-28 August 1998 or 17 May-9 July 1999 (age ≥15 yr, Thailand; or ≥1 yr, Peru), with fever (oral temperature ≥38 C), headache, or selfreported history of fever within the previous 72 hr.…”

Section: Methodsmentioning

confidence: 99%

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Gametocytemia in Plasmodium Vivax and Plasmodium Falciparum Infections

McKenzie

Wongsrichanalai

Magill

et al. 2006

Journal of Parasitology

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Two expert research microscopists, each blinded to the other's reports, diagnosed single-species malaria infections in 2,141 adults presenting at outpatient malaria clinics in Tak Province, Thailand, and Iquitos, Peru, in May-August 1998, May-July 1999, and May-June 2001. Plasmodium vivax patients with gametocytemia had higher fever and higher parasitemia than those without gametocytemia; temperature correlated with parasitemia in the patients with gametocytemia. Plasmodium falciparum patients with gametocytemia had lower fever than those without gametocytemia, but similar parasitemia; temperature correlated with parasitemia in the patients without gametocytemia. Hematologic data in Thailand in 2001 showed lower platelet counts in P. vivax patients with gametocytemia than in the P. vivax patients without gametocytemia, whereas P. falciparum patients with gametocytemia had similar platelet counts but lower red blood cell counts, hemoglobin levels, hematocrit levels, and higher lymphocyte counts than patients without gametocytemia. NIH Public AccessAuthor Manuscript J Parasitol. Author manuscript; available in PMC 2008 August 7. NIH-PA Author ManuscriptNIH-PA Author Manuscript NIH-PA Author ManuscriptGametocytes are the sexual, nonreplicating blood-stage forms of Plasmodium spp. that are transmission agents to mosquitoes. They are products of the asexual, replicating, nontransmissible forms with which the pathology of malaria is associated. Gametocytes themselves are clinically benign, but their production represents a diversion of parasites from the geometric growth of asexual forms; each asexual form that becomes a gametocyte might instead become millions of asexual forms (Carter and Graves, 1988;McKenzie and Bossert, 1998;Talman et al., 2004). Thus, the higher the rate of gametocyte production earlier in an infection, the longer it is until parasitemia reaches a pyrogenic level or any other given density.Gametocytes attract relatively little research attention, although classic studies of adult malaria cases reported positive relationships between gametocytemia, mildness of symptoms, leukocyte proliferation, and age (Thomson, 1911), and higher gametocyte-to-asexual form ratios in patients who cleared infections without treatment than in those requiring drugs (Kitchen and Putnam, 1942). Recent work has focused on children in sub-Saharan Africa infected with P. falciparum in whom gametocytemia is associated with an absence of fever (von Seidlein et al., 2001;Sowunmi et al., 2004), low (von Seidlein et al., 2001Sowunmi et al., 2004) or high (Githeko et al., 1992;Drakeley et al., 1999;Bousema et al., 2004) asexual parasitemia, and either anemia (Drakeley et al., 1999;von Seidlein et al., 2001) or its absence (Sowunmi et al., 2004).Few previous studies have examined characteristics associated with gametocytemia in adults, or in endemic regions other than Africa, or in species other than P. falciparum. Here, we report on gametocytemia in adults visiting local outpatient malaria clinics in western Thailand an...

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“…The extensive quality assurance procedures are described by Forney et al (2001). WBC counts had skewed distributions, as expected (Bain, 2002).…”

Section: Methodsmentioning

confidence: 99%

Section: Nih-pa Author Manuscriptmentioning

confidence: 99%

Section: Methodsmentioning

confidence: 99%

See 1 more Smart Citation

Gametocytemia in Plasmodium Vivax and Plasmodium Falciparum Infections

McKenzie

Wongsrichanalai

Magill

et al. 2006

Journal of Parasitology

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“…Patient enrollment was conducted in two separate increments, 28 May through 28 August 1998 and 17 May through 9 July 1999, during the peak malaria transmission seasons. The inclusion criteria were similar to those used in a previous study (10), as follows: (i) fever (oral temperature, Ն38°C), (ii) history of fever over the past 72 h, or (ii) headaches. In 1998, patients providing a history of antimalarial drug therapy within the previous 2 weeks were excluded from the study.…”

Section: Methodsmentioning

confidence: 99%

Devices for Rapid Diagnosis of Malaria: Evaluation of Prototype Assays That Detect Plasmodium falciparum Histidine-Rich Protein 2 and a Plasmodium vivax -Specific Antigen

et al. 2003

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The ParaSight F test was developed as a pioneer industry effort in the large-scale, process-controlled production of a device for the rapid diagnosis of malaria. This device performed well in field settings but was limited to the detection of a single malaria species, Plasmodium falciparum. The ParaSight F؉V assay advanced upon the ParaSight F test format by incorporating a monoclonal antibody directed against a proprietary Plasmodium vivax-specific antigen, in addition to the antibody directed against P. falciparum histidine-rich protein 2, which was used in the ParaSight F assay. The modified assay was developed to add the capability to detect P. falciparum and P. vivax in a single-test-strip format. The present study evaluated three distinct ParaSight F؉V prototypes with samples from symptomatic patients in regions of Thailand and Peru where malaria is endemic. Over a 2-year enrollment period (1998 and 1999), a total of 4,894 patients consented to participation in the study. Compared with the results for duplicate microscopic examinations of Giemsastained blood smears as the reference diagnostic standard, each successive prototype showed substantial improvement in performance. The final ParaSight F؉V prototype, evaluated in 1999, had an overall sensitivity for detection of asexual P. falciparum parasites of 98%. The sensitivity of the device was 100% for P. falciparum densities of >500 parasites/l, with a sensitivity of 83% for parasite densities of <500/l. The specificity for the exclusion of P. falciparum was 93%. For P. vivax, the overall sensitivity was 87% for the final 1999 prototype. The sensitivities calculated for different levels of P. vivax parasitemia were 99% for parasite densities of >5,000/l, 92% for parasite densities of 1,001 to 5,000/l, 94% for parasite densities of 501 to 1,000/l, and 55% for parasite densities of 1 to 500/l. The specificity for the exclusion of P. vivax was 87%. The areas under the receiver operating characteristic curves for the diagnostic performance of the assay for the detection of P. falciparum and P. vivax were 0.8907 and 0.8522, respectively. These findings indicate that assays for rapid diagnosis have the potential to enhance diagnostic capabilities in those instances in which skilled microscopy is not readily available.The limitations associated with diagnostic microscopy are well documented. These limitations have fostered the development of nonmicroscopic alternatives for the diagnosis of malaria (1,3,6,11,20,21,23,26,36). Devices for the rapid diagnosis of malaria (MRDDs [malaria rapid diagnostic devices]) emerged in the past decade to meet the need for a reliable diagnostic adjunct to microscopy in the clinical setting (40). Timely, accurate diagnosis has the potential to greatly facilitate the provision of appropriate therapeutic interventions, and as the MRDD technology matures, these devices will have a pivotal role in malaria control initiatives.The leading MRDD technology is the immunochromatographic strip (ICS) format, into which antigen-capture immunoas...

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“…Rapid diagnostic tests (RDT) do not solve this problem either. The risk of false negative P. falciparum with RDT (varying from 2% at >5000 parasites mL À1 to 25% at <500 parasites mL À1 [80]) can be considered the risk of receiving ineffective chloroquine therapy where P. vivax, P. malariae or P. ovale also occur.…”

Section: Correct Diagnosis Of P Vivaxmentioning

confidence: 99%