Devices for rapid diagnosis of malaria:: Evaluation of prototype assays that detect Plasmodium falciparum histidine-rich protein 2 and a Plasmodium vivax-specific antigen

被引:53
|
作者
Forney, JR
Wongsrichanalai, C
Magill, AJ
Craig, LG
Sirichaisinthop, J
Bautista, CT
Miller, RS
Ockenhouse, CF
Kester, KE
Aronson, NE
Andersen, EM
Quino-Ascurra, HA
Vidal, C
Moran, KA
Murray, CK
DeWitt, CC
Heppner, DG
Kain, KC
Ballou, WR
Gasser, RA
机构
[1] US Mil Acad, ATTN MADN C&LS, COL Forney, Official Mail & Distribuat Ctr, W Point, NY 10996 USA
[2] Armed Forces Res Inst Med Sci, Bangkok 10400, Thailand
[3] Vector Born Dis Control Off, Phrabuddhabat, Saraburi, Thailand
[4] Naval Med Res Ctr Detachment, Lima, Peru
[5] Hosp Apoyo, Iquitos, Peru
[6] Walter Reed Army Med Ctr, Washington, DC 20307 USA
[7] Walter Reed Army Inst Res, Silver Spring, MD USA
[8] Toronto Gen Hosp, Toronto, ON, Canada
[9] Univ Toronto, Toronto, ON, Canada
[10] Brooke Army Med Ctr, San Antonio, TX USA
[11] Wilford Hall USAF Med Ctr, Lackland AFB, TX 78236 USA
关键词
D O I
10.1128/JCM.41.6.2358-2366.2003
中图分类号
Q93 [微生物学];
学科分类号
071005 ; 100705 ;
摘要
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 Giemsa-stained 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/mul, with a sensitivity of 83% for parasite densities of :less than or equal to500/mul. 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/mul, 92% for parasite densities of 1,001 to 5,000/mul, 94% for parasite densities of 501 to 1,000/mul, and 55% for parasite densities of 1 to 500/mul. 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.
引用
收藏
页码:2358 / 2366
页数:9
相关论文
共 50 条
  • [21] Modelling the dynamics of Plasmodium falciparum histidine-rich protein 2 in human malaria to better understand malaria rapid diagnostic test performance
    Marquart, Louise
    Butterworth, Alice
    McCarthy, James S.
    Gatton, Michelle L.
    MALARIA JOURNAL, 2012, 11
  • [22] Effect of sequence variation in Plasmodium falciparum Histidine-Rich protein 2 on binding of specific monoclonal antibodies:: Implications for rapid diagnostic tests for malaria
    Lee, Nelson
    Baker, Joanne
    Andrews, Kathy T.
    Gatton, Michelle L.
    Bell, David
    Cheng, Qin
    McCarthy, James
    JOURNAL OF CLINICAL MICROBIOLOGY, 2006, 44 (08) : 2773 - 2778
  • [23] Genetic Sequence Variation in the Plasmodium falciparum Histidine-Rich Protein 2 Gene from Field Isolates in Tanzania: Impact on Malaria Rapid Diagnosis
    Kaaya, Robert D.
    Amour, Caroline
    Matowo, Johnson J.
    Mosha, Franklin W.
    Kavishe, Reginald A.
    Beshir, Khalid B.
    GENES, 2022, 13 (09)
  • [24] Implications of Parasites Lacking Plasmodium falciparum Histidine-Rich Protein 2 on Malaria Morbidity and Control When Rapid Diagnostic Tests Are Used for Diagnosis
    Gatton, Michelle L.
    Dunn, Jessica
    Chaudhry, Alisha
    Ciketic, Sadmir
    Cunningham, Jane
    Cheng, Qin
    JOURNAL OF INFECTIOUS DISEASES, 2017, 215 (07): : 1156 - 1166
  • [25] An electrochemical aptamer-based biosensor targeting Plasmodium falciparum histidine-rich protein II for malaria diagnosis
    Lo, Young
    Cheung, Yee-Wai
    Wang, Lin
    Lee, Megan
    Figueroa-Miranda, Gabriela
    Liang, Shaolin
    Mayer, Dirk
    Tanner, Julian Alexander
    BIOSENSORS & BIOELECTRONICS, 2021, 192
  • [26] Variation in Plasmodium falciparum Histidine-Rich Protein 2 (Pfhrp2) and Plasmodium falciparum Histidine-Rich Protein 3 (Pfhrp3) Gene Deletions in Guyana and Suriname
    Okoth, Sheila Akinyi
    Abdallah, Joseph F.
    Ceron, Nicolas
    Adhin, Malti R.
    Chandrabose, Javin
    Krishnalall, Karanchand
    Huber, Curtis S.
    Goldman, Ira F.
    de Oliveira, Alexandre Macedo
    Barnwell, John W.
    Udhayakumar, Venkatachalam
    PLOS ONE, 2015, 10 (05):
  • [27] Deletions in the Plasmodium falciparum histidine-rich protein 2 gene: An emerging threat to the elimination of malaria in India
    Singh, Vineeta
    Kojom, Loick Pradel
    JOURNAL OF VECTOR BORNE DISEASES, 2019, 56 (01) : 85 - 86
  • [28] Major Threat to Malaria Control Programs by Plasmodium falciparum Lacking Histidine-Rich Protein 2, Eritrea
    Berhane, Araia
    Anderson, Karen
    Mihreteab, Selam
    Gresty, Karryn
    Rogier, Eric
    Mohamed, Salih
    Hagos, Filmon
    Embaye, Ghirmay
    Chinorumba, Anderson
    Zehaie, Assefash
    Dowd, Simone
    Waters, Norman C.
    Gatton, Michelle L.
    Udhayakumar, Venkatachalam
    Cheng, Qin
    Cunningham, Jane
    EMERGING INFECTIOUS DISEASES, 2018, 24 (03) : 462 - 470
  • [29] Magneto Immunoassays for Plasmodium falciparum Histidine-Rich Protein 2 Related to Malaria based on Magnetic Nanoparticles
    de Souza Castilho, M.
    Laube, T.
    Yamanaka, H.
    Alegret, S.
    Pividori, M. I.
    ANALYTICAL CHEMISTRY, 2011, 83 (14) : 5570 - 5577
  • [30] Evaluation of a rapid test for histidine rich protein 2 for diagnosis of Plasmodium falciparum infection in Cameroonian children
    Bechem, NN
    Leke, RFG
    Tietche, F
    Taylor, DW
    TRANSACTIONS OF THE ROYAL SOCIETY OF TROPICAL MEDICINE AND HYGIENE, 1999, 93 (01) : 46 - 46