Peer–reviewed publications from PATH Diagnostics

Related program: Diagnostics

Peer-reviewed publications from PATH Diagnostics researchers and scientists in collaboration with external partners.

Publications, 2017-present

COVID-19

Golden, A., Oliveira-Silva, Domingo, G. et al. (2023). Antigen concentration, viral load, and test performance for SARS-CoV-2 in multiple specimen types. 2023. PLoS ONE, 18(7).

Golden, A., Cantera, J., Domingo, G. et al. A Reagent and Virus Benchmarking Panel for a Uniform Analytical Performance Assessment of N Antigen-Based Diagnostic Tests for COVID-19. 2023. Microbiology Spectrum, e0373122.

Mvundura M, Ngwira LG, Sharma B. et al. Cost of wastewater-based environmental surveillance for SARS-CoV-2: Evidence from pilot sites in Blantyre, Malawi and Kathmandu, Nepal. 2022. PLoS Global Public Health, 2(12), e0001377.

Zobrist S, Oliveira-Silva M, Vieira AM, et al. Screening for SARS-CoV-2 in close contacts of individuals with confirmed infection: performance and operational considerations. The Journal of Infectious Diseases. May 20, 2022: jiac204. doi:10.1093/infdis/jiac204

Montaño MA, Bemer MJ, Heller KB, et al. Performance of anterior nares and tongue swabs for nucleic acid, Nucleocapsid and Spike antigen testing for detecting SARS-CoV-2 against nasopharyngeal PCR and viral culture. International Journal of Infectious Diseases. February 8, 2022:S1201-9712(22)00086-8. doi:10.1016/j.ijid.2022.02.009

Cate DM, Bishop JD, Hsieh HV, et al. Antibody Screening Results for Anti-Nucleocapsid Antibodies Toward the Development of a Lateral Flow Assay to Detect SARS-CoV-2 Nucleocapsid Protein. ACS Omega. September 21, 2021. doi:10.1021/acsomega.1c01253

Cantera JL, Cate DM, Golden A, et al. Screening Antibodies Raised against the Spike Glycoprotein of SARS-CoV-2 to Support the Development of Rapid Antigen Assays. ACS Omega. July 27, 2021. doi:10.1021/acsomega.1c01321

Zhang JY, Bender AT, Boyle DS, Drain PK, Posner JD. Current state of commercial point-of-care nucleic acid tests for infectious diseases. Analyst. 2021;146(8):2449-2462. doi:10.1039/D0AN01988G

Grant BD, Anderson CE, Williford JR, et al. SARS-CoV-2 coronavirus nucleocapsid antigen-detecting half-strip lateral flow assay toward the development of point-of-care tests using commercially available Reagents. Analytical Chemistry. 2020;92(16):11305–11309. doi:10.1021/acs.analchem.0c01975.

Cantera J, Cate D, Golden A, et al. Screening antibodies raised against the spike glycoprotein of SARS-CoV-2 to support the development of rapid antigen assays. ChemRxiv. 2020. https://doi.org/10.26434/chemrxiv.12899672.v1.

Diabetes

Storey HL, van Pelt MH, Bun S, et al. Diagnostic accuracy of self-administered urine glucose test strips as a diabetes screening tool in a low-resource setting in Cambodia. BMJ Open. 2018;8(3):e019924. doi:10.1136/bmjopen-2017-019924.

Diagnostics development

Peck, R., Storey, H. L., et al. From biorepositories to data repositories: Open-access resources accelerate early R&D and validation of equitable diagnostic tools. PLoS Global Public Health. 2023; 3(8), e0002044. doi:10.1371/journal.pgph.0002044

Shaw, A. G., Troman, C., et al. (2023). Defining a research agenda for environmental wastewater surveillance of pathogens. Nature Medicine. doi: 0.1038/s41591-023-02457-7

Anderson CE, Huynh T, Gasperino DJ, et al. Automated liquid handling robot for rapid lateral flow assay development. Analytical and Bioanalytical Chemistry. January 29, 2022. doi:10.1007/s00216-022-03897-9

Brindle E, Lillis L, Barney R, et al. A multicenter analytical performance evaluation of a multiplexed immunoarray for the simultaneous measurement of biomarkers of micronutrient deficiency, inflammation and malarial antigenemia. PLoS ONE. 2021;16(11):e0259509. doi:10.1371/journal.pone.0259509

Bender AT, Sullivan BP, Lillis L, Posner JD. Enzymatic and chemical-based methods to inactivate endogenous blood ribonucleases for nucleic acid diagnostics. The Journal of Molecular Diagnostics. 2020;22(8):1030–1040. doi:10.1016/j.jmoldx.2020.04.211.

Cantera JL, White H, Diaz MH, et al. Assessment of eight nucleic acid amplification technologies for potential use to detect infectious agents in low-resource settings. PLoS ONE. 2019;14(4):e0215756. doi:10.1371/journal.pone.0215756.

Beall SG, Cantera J, Diaz MH, et al. Performance and workflow assessment of six nucleic acid extraction technologies for use in resource-limited settings. PLoS ONE. 2019;14(4):e0215753. doi:10.1371/journal.pone.0215753.

Bender AT, Borysiak MD, Levenson AM, Lillis L, Boyle DS, Posner JD. Semiquantitative nucleic acid test with simultaneous isotachophoretic extraction and amplification. Analytical Chemistry. 2018;90(12):7221–7229. doi:10.1021/acs.analchem.8b00185.

HIV

Jenkins D, Peck R, Fernando A Development of an approach to monitor the manufacturing consistency of HIV rapid diagnostic tests: Panel qualification and potential impact on country programs. PLoS ONE. 2023.18(4): e0284175.

Zhang JY, Bender AT, Sullivan B, et al. HIV Pre-Exposure Prophylaxis Adherence Test Using Reverse Transcription Isothermal Amplification Inhibition Assay. Analytical Methods: Advancing Methods and Applications. 2022; 1361–70. doi: 0.1039/d2ay00008c.

Bender AT, Sullivan BP, Zhang JY, et al. HIV detection from human serum with paper-based isotachophoretic RNA extraction and reverse transcription recombinase polymerase amplification. Analyst. 2021;146(9):2851-2861. doi:10.1039/D0AN02483J.

Bender AT, Sullivan BP, Lillis L, Posner JD. Enzymatic and chemical-based methods to inactivate endogenous blood ribonucleases for nucleic acid diagnostics. The Journal of Molecular Diagnostics. 2020;22(8):1030–1040. doi:10.1016/j.jmoldx.2020.04.211.

Drain PK, Dorward J, Bender A, et al. Point-of-care HIV viral load testing: an essential tool for a sustainable global HIV/AIDS response. Clinical Microbiology Reviews. 2019;32(3):e00097-18. doi:10.1128/CMR.00097-18.

Malaria

Adissu, W, Brito, M, Gerth-Guyette, E. et al. Clinical performance validation of the STANDARD G6PD test: A multi-country pooled analysis. PLoS Neglected Tropical Disease. 2023; doi/10.1371/journal.pntd.0011652

Green, R, Manchola, C, Gerth-Guyette E. et al. Integration of serial self-testing for COVID-19 as part of contact tracing in the Brazilian public health system: A pragmatic trial protocol. PLoS ONE. 2023; doi: 10.1371/journal.pone.0284659

Gerth-Guyette E, Nguyen H, Quang Phúc B et al. Assessing the Operational Feasibility of Integrating Point-of-Care G6PD Testing into Plasmodium vivax Malaria Management in Vietnam. Pathogens. 2023; 12(5).

Ding XC, Incardona S, Serra-Casas E, Charnaud SC, Slater HC, Domingo GJ et al. Malaria in pregnancy (MiP) studies assessing the clinical performance of highly sensitive rapid diagnostic tests (HS-RDT) for Plasmodium falciparum detection. Malaria Journal. 2023;22(1):60

Brindle E, Lillis, L, Barney R, et al. Multiplexed micronutrient, inflammation, and malarial antigenemia assessment using a plasma fractionation device. PLoS ONE. 2022. 17(11), e0277835.

Jang IK, Jiménez A, Rashid A, et al. Comparison of two malaria multiplex immunoassays that enable quantification of malaria antigens. Malaria Journal. 2022;21(1). doi:10.1186/s12936-022-04203-9

Slater HC, Ding XC, Knudson S, et al. Performance and utility of more highly sensitive malaria rapid diagnostic tests. BMC Infectious Disease Journal. 2022;22(1):121. doi:10.1186/s12879-021-07023-5

Pal S, Myburgh J, Bansil P, et al. Reference and point-of-care testing for G6PD deficiency: Blood disorder interference, contrived specimens, and fingerstick equivalence and precision. PLoS ONE. 2021;16(9):e0257560. doi:10.1371/journal.pone.0257560

Barney R, Velasco M, Cooper CA, et al. Diagnostic Characteristics of Lactate Dehydrogenase on a Multiplex Assay for Malaria Detection Including the Zoonotic Parasite Plasmodium Knowlesi. The American Journal of Tropical Medicine and Hygiene. 2021; 106 (1) 275–82. doi.org/10.4269/ajtmh.21-0532.

Whittaker C, Slater H, Nash R, et al. Global Patterns of Submicroscopic Plasmodium Falciparum Malaria Infection. The Lancet Microbe 2, 2021; e366–74. https://doi.org/10.1016/S2666-5247(21)00055-0.

Zobrist S, Brito M, Garbin E, et al. Evaluation of a point-of-care diagnostic to identify glucose-6-phosphate dehydrogenase deficiency in Brazil. PLoS Neglected Tropical Diseases. 2021;15(8):e0009649. doi:10.1371/journal.pntd.0009649.

Gerth-Guyette E, Adissu W, Brito M, et al. Usability of a point-of-care diagnostic to identify glucose-6-phosphate dehydrogenase deficiency: a multi-country assessment of test label comprehension and results interpretation. Malaria Journal. 2021;20(1):307. doi:10.1186/s12936-021-03803-1.

Jang IK, Aranda S, Barney R, et al. Assessment of Plasmodium antigens and CRP in dried blood spots with multiplex malaria array. Journal of Parasitic Disease. Published online January 3, 2021. doi:10.1007/s12639-020-01325-2.

Tandon R, Spark-DePass E, Sharma A, et al. Malaria radical cure opportunity assessment in India: Discussing opportunities through stakeholder convening workshop and recommendation for improved access to malaria treatment. Journal of Vector-Borne Diseases. 2020;57(2):182. doi:10.4103/0972-9062.310865.

Galatas B, Mayor A, Gupta H, et al. Field performance of ultrasensitive and conventional malaria rapid diagnostic tests in southern Mozambique. Malaria Journal. 2020;19(1):451. doi:10.1186/s12936-020-03526-9.

Reichert EN, Hume JCC, Sagara I, et al. Ultra-sensitive RDT performance and antigen dynamics in a high-transmission Plasmodium falciparum setting in Mali. Malaria Journal. 2020;19(1):323. doi:10.1186/s12936-020-03389-0.

Jang IK, Tyler A, Lyman C, et al. Multiplex Human Malaria Array: Quantifying Antigens for Malaria Rapid Diagnostics. The American Journal of Tropical Medicine and Hygiene. 2020;102(6):1366-1369. doi:10.4269/ajtmh.19-0763.

Woodford J, Collins KA, Odedra A, et al. An experimental human blood-stage model for studying Plasmodium malariae infection. The Journal of Infectious Diseases. 2020;221(6):948–955. doi:10.1093/infdis/jiz102.

Jang IK, Tyler A, Lyman C, et al. Multiplex human malaria array: quantifying antigens for malaria rapid diagnostics. The American Journal of Tropical Medicine and Hygiene. 2020;102(6):1366–1369. doi:10.4269/ajtmh.19-0763.

Pfeffer DA, Ley B, Howes RE, et al. Quantification of glucose-6-phosphate dehydrogenase activity by spectrophotometry: a systematic review and meta-analysis. PLoS Medicine. 2020;17(5):e1003084. doi:10.1371/journal.pmed.1003084.

Chu CS, Bancone G, Kelley M, et al. Optimizing G6PD testing for Plasmodium vivax case management and beyond: why sex, counseling, and community engagement matter. Wellcome Open Research. 2020;5:21. doi:10.12688/wellcomeopenres.15700.2.

Reichert EN, Hume JCC, Sagara I, et al. Ultra-sensitive RDT performance and antigen dynamics in a high-transmission Plasmodium falciparum setting in Mali. Malaria Journal. 2020;19(323). https://doi.org/10.1186/s12936-020-03389-0.

Jang IK, Tyler A, Lyman C, et al. Simultaneous quantification of Plasmodium antigens and host factor C-reactive protein in asymptomatic individuals with confirmed malaria by use of a novel multiplex immunoassay. Journal of Clinical Microbiology. 2019;57(1):e00948-18. doi:10.1128/jcm.00948-18.

Pal S, Bansil P, Bancone G, et al. Evaluation of a novel quantitative test for glucose-6-phosphate dehydrogenase deficiency: bringing quantitative testing for glucose-6-phosphate dehydrogenase deficiency closer to the patient. The American Journal of Tropical Medicine and Hygiene. 2019;100(1):213–221. doi:10.4269/ajtmh.18-0612.

Domingo GJ, Advani N, Satyagraha AW, et al. Addressing the gender-knowledge gap in glucose-6-phosphate dehydrogenase deficiency: challenges and opportunities. International Health. 2019;11(1):7–14. doi:10.1093/inthealth/ihy060.

Greenhouse B, Daily J, Guinovart C, et al. Priority use cases for antibody-detecting assays of recent malaria exposure as tools to achieve and sustain malaria elimination. Gates Open Research. 2019;3:131. doi:10.12688/gatesopenres.12897.1.

Slater HC, Ross A, Felger I, et al. The temporal dynamics and infectiousness of subpatent Plasmodium falciparum infections in relation to parasite density. Nature Communications. 2019;10(1):1433. doi:10.1038/s41467-019-09441-1.

Jang IK, Das S, Barney RS, et al. A new highly sensitive enzyme-linked immunosorbent assay for the detection of Plasmodium falciparum histidine-rich protein 2 in whole blood. Malaria Journal. 2018;17(1):403. doi:10.1186/s12936-018-2545-5.

Anderle A, Bancone G, Domingo GJ, Gerth-Guyette E, Pal S, Satyagraha AW. Point-of-care testing for G6PD deficiency: opportunities for screening. International Journal of Neonatal Screening. 2018;4(4):34. doi:10.3390/ijns4040034.

Landier J, Haohankhunnatham W, Das S, et al. Operational performance of a Plasmodium falciparum ultrasensitive rapid diagnostic test for detection of asymptomatic infections in eastern Myanmar. Journal of Clinical Microbiology. 2018;56(8):e00565. doi:10.1128/jcm.00565-18.

Kalnoky M, Bancone G, Kahn M, et al. Cytochemical flow analysis of intracellular G6PD and aggregate analysis of mosaic G6PD expression. European Journal of Haematology. 2018;100(3):294–303. doi:10.1111/ejh.13013.

Das S, Peck RB, Barney R, et al. Performance of an ultra-sensitive Plasmodium falciparum HRP2-based rapid diagnostic test with recombinant HRP2, culture parasites, and archived whole blood samples. Malaria Journal. 2018;17(1):118. doi:10.1186/s12936-018-2268-7.

Thriemer K, Bobogare A, Ley B, et al. Quantifying primaquine effectiveness and improving adherence: a round table discussion of the APMEN Vivax Working Group. Malaria Journal. 2018;17(1):241. doi:10.1186/s12936-018-2380-8

Markwalter CF, Jang IK, Burton RA, Domingo GJ, Wright DW. Biolayer interferometry predicts ELISA performance of monoclonal antibody pairs for Plasmodium falciparum histidine-rich protein 2. Analytical Biochemistry. 2017;534:10-13. doi:10.1016/j.ab.2017.07.010

Bancone G, Kalnoky M, Chu CS, et al. The G6PD flow-cytometric assay is a reliable tool for diagnosis of G6PD deficiency in women and anaemic subjects. Scientific Reports. 2017;7(1):9822. doi:10.1038/s41598-017-10045-2

Hanron AE, Billman ZP, Seilie AM, et al. Multiplex, DNase-free one-step reverse transcription PCR for Plasmodium 18S rRNA and spliced gametocyte-specific mRNAs. Malaria Journal. 2017;16(1):208. doi:10.1186/s12936-017-1863-3

Kahn M, LaRue N, Zhu C, et al. Recombinant human G6PD for quality control and quality assurance of novel point-of-care diagnostics for G6PD deficiency. PLoS ONE. 2017;12(5):e0177885. doi:10.1371/journal.pone.0177885

Maternal, newborn and child health
Neglected tropical diseases

Cantera JL, White HN, Forrest MS, et al. Sensitive and semiquantitative detection of soil-transmitted helminth infection in stool using a recombinase polymerase amplification-based assay. PLoS Neglected Tropical Diseases. 2021;15(9):e0009782. doi:10.1371/journal.pntd.0009782.

Cools P, van Lieshout L, Koelewijn R, et al. First international external quality assessment scheme of nucleic acid amplification tests for the detection of Schistosoma and soil-transmitted helminths, including Strongyloides: a pilot study. PLoS Neglected Tropical Diseases. 2020;14(6):e0008231. doi:10.1371/journal.pntd.0008231.

Bennuru S, Oduro-Boateng G, Osigwe C, et al. Integrating multiple biomarkers to increase sensitivity for the detection of Onchocerca volvulus infection. Journal of Infectious Diseases. 2020;221(11):1805–1815. doi:10.1093/infdis/jiz307.

Storey HL, Agarwal N, Cantera J, et al. Formative research to inform development of a new diagnostic for soil-transmitted helminths: going beyond the laboratory to ensure access to a needed product. PLoS Neglected Tropical Diseases. 2019;13(5):e0007372. doi:10.1371/journal.pntd.0007372.

Coffeng LE, Stolk WA, Golden A, de los Santos T, Domingo GJ, de Vlas SJ. Predictive value of Ov16 antibody prevalence in different subpopulations for elimination of African onchocerciasis. American Journal of Epidemiology. 2019;188(9):1723–1732. doi:10.1093/aje/kwz109.

Wanji S, Esum ME, Njouendou AJ, et al. Mapping of lymphatic filariasis in loiasis areas: a new strategy shows no evidence for Wuchereria bancrofti endemicity in Cameroon. PLoS Neglected Tropical Diseases. 2019;13(3):e0007192. doi:10.1371/journal.pntd.0007192.

Surakat OA, Sam-Wobo SO, Santos TDL, et al. Seroprevalence of onchocerciasis in Ogun State, Nigeria after ten years of mass drug administration with ivermectin. Southern African Journal of Infectious Diseases. 2018;33(3):65-71. doi:10.1080/23120053.2017.1408233

Dieye Y, Storey HL, Barrett KL, et al. Feasibility of utilizing the SD BIOLINE Onchocerciasis IgG4 rapid test in onchocerciasis surveillance in Senegal. PLoS Neglected Tropical Diseases. 2017;11(10):e0005884. doi:10.1371/journal.pntd.0005884

Nutrition

Brindle E, Lillis L, Barney R, et al. A multicenter analytical performance evaluation of a multiplexed immunoarray for the simultaneous measurement of biomarkers of micronutrient deficiency, inflammation and malarial antigenemia. PLoS ONE. 2021;16(11):e0259509. doi:10.1371/journal.pone.0259509

Smith E, Lee J, Allen L, et al. Target Product Profiles for a Micronutrient Assessment Tool and Associated Blood Collection Device for Use in Population-Based Surveys: An Expert Consensus.; 2021. doi:10.1101/2021.05.13.21257124

Arndt MB, Cantera JL, Mercer LD, et al. Validation of the Micronutrient and Environmental Enteric Dysfunction Assessment Tool and evaluation of biomarker risk factors for growth faltering and vaccine failure in young Malian children. PLoS Neglected Tropical Diseases. 2020;14(9):e0008711. doi:10.1371/journal.pntd.0008711.

Brindle E, Lillis L, Barney R, Bansil P, Lyman C, Boyle DS. Measurement of micronutrient deficiency-associated biomarkers in dried blood spots using a multiplexed immunoarray. PLoS ONE. 2019;14(1):e0210212. doi:10.1371/journal.pone.0210212.

Craft N, Arredondo F, Fleshman M, et al. Measurement of nutritional and inflammatory biomarkers in dry plasma spots (DPS) (P10-097-19). Current Developments in Nutrition. 2019;3(Supplement_1). doi:10.1093/cdn/nzz034.P10-097-19.

Polio

Israeli, S., Golden, A., Atalig, M. et al. A Novel Point-of-Care Rapid Diagnostic Test for Screening Individuals for Antibody Deficiencies. Journal of Clinical Immunology. 2021. doi:10.1007/s10875-021-01179-0

Linden YS, Fagnant-Sperati CS, Kossik AL, et al. Method Development for Enteric Virus Recovery from Primary Sludge. Viruses. 2021;13(3):440. doi:10.3390/v13030440

Fagnant-Sperati CS, Ren Y, Zhou NA, et al. Validation of the bag-mediated filtration system for environmental surveillance of poliovirus in Nairobi, Kenya. Journal of Applied Microbiology. 2021;130(3):971-981. doi:10.1111/jam.14807

Fagnant‐Sperati CS, Ren Y, Zhou NA, et al. Validation of the bag-mediated filtration system for environmental surveillance of poliovirus in Nairobi, Kenya. Journal of Applied Microbiology. 2020. doi:10.1111/jam.14807.

Zhou NA, Fagnant-Sperati CS, Komen E, et al. Feasibility of the bag-mediated filtration system for environmental surveillance of poliovirus in Kenya. Food and Environmental Virology. 2020;12(1):35–47. doi:10.1007/s12560-019-09412-1.

Falman JC, Fagnant-Sperati CS, Kossik AL, Boyle DS, Meschke JS. Evaluation of secondary concentration methods for poliovirus detection in wastewater. Food and Environmental Virology. 2019;11(1):20–31. doi:10.1007/s12560-018-09364-y.

van Zyl WB, Zhou NA, Wolfaardt M, et al. Detection of potentially pathogenic enteric viruses in environmental samples from Kenya using the bag-mediated filtration system. Water Supply. 2019;19(6):1668–1676. doi:10.2166/ws.2019.046.

Zhou NA, Fagnant-Sperati CS, Shirai JH, et al. Evaluation of the bag-mediated filtration system as a novel tool for poliovirus environmental surveillance: results from a comparative field study in Pakistan. PLoS ONE. 2018;13(7):e0200551. doi:10.1371/journal.pone.0200551.

Fagnant CS, Sánchez-Gonzalez LM, Zhou NA, et al. Improvement of the bag-mediated filtration system for sampling wastewater and wastewater-impacted waters. Food and Environmental Virology. 2018;10(1):72–82. doi:10.1007/s12560-017-9311-7.

Fagnant CS, Toles M, Zhou NA, et al. Development of an elution device for ViroCap virus filters. Environmental Monitoring and Assessment. 2017;189(11):574. doi:10.1007/s10661-017-6258-y.

Fagnant CS, Kossik AL, Zhou NA, et al. Use of Preservative Agents and Antibiotics for Increased Poliovirus Survival on Positively Charged Filters. Food and Environmental Virology. 2017;9(4):383-394. doi:10.1007/s12560-017-9306-4.

Tuberculosis

Cantera JL, Rashid AA, Boyle DS et al. Isolation and purification of lipoarabinomannan from urine of adults with active TB. International Journal of Tuberculosis and Lung Disease. 2023 Jan 1;27(1):75-77. doi: 10.5588/ijtld.22.0372​

Cantera JL, Lillis LM, Peck RB, et al. Performance of novel antibodies for lipoarabinomannan to develop diagnostic tests for Mycobacterium tuberculosis. PLoS ONE. 2022;17(9):e0274415. doi:10.1371/journal.pone.0274415

Lu HW, Sakamuri R, Kumar P, et al. Integrated nucleic acid testing system to enable TB diagnosis in peripheral settings. Lab on a Chip. 2020;20(21):4071–4081. doi:10.1039/d0lc00445f.

Adepoyibi T, Lilis L, Greb H, Boyle D. Which attributes within target product profiles for tuberculosis diagnostics are the most important to focus on? The International Journal of Tuberculosis and Lung Disease. 2018;22(4):425–428. doi:10.5588/ijtld.17.0312.

Typhoid

Hagedorn B, Boyle D, Meschke JS. Estimates of the cost to build a stand-alone environmental surveillance system for typhoid in low- and middle-income countries. PLOS Glob Public Health. 2023 Jan 26;3(1):e0001074. doi: 10.1371/journal.pgph.0001074. eCollection 2023.

Matrajt G, Lillis L, Meschke JS. Review of methods suitable for environmental surveillance of Salmonella typhi and paratyphi. Clinical Infectious Diseases. 2020;71(Supplement_2):S79–S83. doi:10.1093/cid/ciaa487.