Lateral Akış İmmünoassay Testleri
Özet
Karbapenemazların hızlı ve doğru bir şekilde tanımlanması hem hasta hem de enfeksiyon kontrol önlemleri için kritiktir. Lateral akış immunoassay testleri (LFT) karbapenemazların belirlenmesinde European Committee on Antimicrobial Susceptibility Testing (EUCAST) ve Clinical Laboratory Standards Institute (CLSI) tarafından önerilmektedir. LFT hızlı, güvenilir, basit, kolay 15-30 dakika içinde sonuç alınabilen testlerdir. Pozitif sinyal veren kan kültürü şişesinden ve rektal sürüntü örneklerinden çalışılabilen LFT’ler de geliştirilmiştir. Bu derlemede LFT’lerinin prensibi, avantajları ve sınırlılıkları güncel bilgiler ışığında sunulmuştur.
Rapid and accurate identification of carbapenemases is critical for both patient and infection control measures. Lateral flow tests (LFTs) are recommended by the European Committee on Antimicrobial Susceptibility Testing (EUCAST) and Clinical Laboratory Standards Institute (CLSI) for the identification of carbapenemases. LFT is a rapid, reliable, simple and easy test that can be performed within 15-30 minutes. LFTs that can be performed on blood culture bottles and rectal swabs that give a positive signal have also been developed. In this review, the principle, advantages and limitations of LFTs are presented in the light of current knowledge.
Referanslar
Logan LK, Weinstein RA. The epidemiology of carbapenem resistant Enterobacteriaceae: the impact and evolution of a global menace. J Infect Dis. 2017;215:28-36. doi:10.1093/infdis/jiw282
Lupo A, Papp-Wallace KM, Sendi P, Bonomo RA, Endimiani A. Non-phenotypic tests to detect and characterize antibiotic resistance mechanisms in Enterobacteriaceae. Diagn Microbiol Infect Dis. 2013;77: 179 -194.
doi:10.1016/j.diagmicrobio.2013.06.001.
Rood IGH, Li Q. Review: molecular detection of extended spectrum-beta-lactamase- and carbapenemase-producing Enterobacteriaceae in a clinical setting. Diagn Microbiol Infect Dis. 2017;89:245-250. doi:10.1016/j.diagmicrobio.2017.07.013.
Tamma PD, Simner PJ. Phenotypic Detection of Carbapenemase-Producing Organisms from Clinical Isolates. J Clin Microbiol. 2018; 56(11):e01140-58. doi: 10.1128/JCM.01140-18.
Goodman KE, Simner PJ, Tamma PD, Milstone AM. Infection control implications of heterogeneous resistance mechanisms in carbapenem-resistant Enterobacteriaceae (CRE). Expert Rev Anti Infect Ther. 2016; 14:95-108.
doi:10.1586/14787210.2016.1106940.
Boutal H, Moguet C, Pommiès L, Simon S, Naas T, Volland H. The Revolution of Lateral Flow Assay in the Field of AMR Detection. Diagnostics (Basel). 2022;12(7):1744-70 doi: 10.3390/diagnostics12071744.
Land KJ, Boeras DI, Chen XS, Ramsay AR, Peeling RW REASSURED Diagnostics to Inform Disease Control Strategies, Strengthen Health Systems and Improve Patient Outcomes. Nat. Microbiol. 2019;4:46-54.
Hamprecht A, Vehreschild JJ, Seifert H, Saleh A. Rapid Detection of NDM, KPC and OXA-48 Carbapenemases Directly from Positive Blood Cultures Using a New Multiplex Immunochromatographic Assay. PLoS ONE 2018; 13: e0204157.
Glupczynski Y, Evrard S, Huang TD, Bogaerts P. Evaluation of the RESIST-4 K-SeT Assay, a Multiplex Immunochromatographic Assay for the Rapid Detection of OXA-48-Like, KPC, VIM and NDM Carbapenemases. J. Antimicrob. Chemother. 2019; 74: 1284-1287.
Hong J, Kang D, Kim D. Performance Evaluation of the Newly Developed In Vitro Rapid Diagnostic Test for Detecting OXA-48-Like, KPC-, NDM-, VIM- and IMP-Type Carbapenemases: The RESIST-5 O.K.N.V.I. Multiplex Lateral Flow Assay. Antibiotics 2021; 10: 460.
El Kettani A, Maaloum F, Nzoyikorera N, Khalis M, Katfy K, Belabbes H, et alEvaluation of the Performances of the Rapid Test RESIST-5 O.O.K.N.V Used for the Detection of Carbapenemases-Producing Enterobacterales. Antibiotics. 2021; 10: 953-62.
Han R, Guo Y, Peng M, Shi Q, Wu S, Yang Y, et al. Evaluation of the Immunochromatographic NG-Test Carba 5, RESIST-5 O.O.K.N.V., and IMP K-SeT for Rapid Detection of KPC-, NDM-, IMP-, VIM-Type, and OXA-48-like Carbapenemase Among Enterobacterales. Front. Microbiol. 2021; 11: 3296-3303.
Boutal H, Vogel A, Bernabeu S, Devilliers K, Creton E, Cotellon G, et al. A Multiplex Lateral Flow Immunoassay for the Rapid Identification of NDM-, KPC-, IMP- and VIM-Type and OXA-48-like Carbapenemase-Producing Enterobacteriaceae. J Antimicrob Chemother 2018; 73: 909-915
Di Nardo F, Chiarello M, Cavalera S, Baggiani C, Anfossi L. Ten Years of Lateral Flow Immunoassay Technique Applications: Trends, Challenges and Future Perspectives. Sensors 2021; 21: 5185-5218.
Posthuma-Trumpie G.A, Korf J, van Amerongen A. Lateral Flow (Immuno)assay: Its Strengths, Weaknesses, Opportunities and Threats. A Literature Survey. Anal. Bioanal. Chem. 2009; 393: 569-582.
Park J. An Optimized Colorimetric Readout Method for Lateral Flow Immunoassays. Sensors 2018; 18: 4084-4093.
Xiao R, Lu L, Rong Z, Wang C, Peng Y, Wang F, et al. Portable and Multiplexed Lateral Flow Immunoassay Reader Based on SERS for Highly Sensitive Point-of-Care Testing. Biosens. Bioelectron. 2020; 168: 112524.
Koczula KM, Gallotta A. Lateral Flow Assays. Essays Biochem. 2016; 60: 111-120.
Andryukov BG. Six Decades of Lateral Flow Immunoassay: From Determining Metabolic Markers to Diagnosing COVID-19. AIMS Microbiol. 2020; 6: 280-304.
Tarlton NJ, Wallace MA, Potter RF, Zhang K, Dantas G, Dubberke ER, Burnham CD, Yarbrough ML. Evaluation of the NG-Test CARBA 5 Lateral Flow Assay with an IMP-27-Producing Morganella morganii and Other Morganellaceae. Microbiol. Spectr. 2023; 11: e0079323.
NG-Biotech Laboratories. NG-Test CARBA 5 Package Insert. ENO 035CAR Rev: 220125 Guipry, France. 2022. Available online: https://ngbiotech.com/amr-doc/Instructions_for_use_NG-Test-CARBA-5_for_the_United_States_v220125.pdf (accessed on 5 May 2025).
Genobio Pharmaceutical. Carbapenem-Resistant K.N.I.V.O. Detection K-Set Product Insert. 2021. Available online: https: //www.genobio-pharm.com/carbapenem-resistant-k-n-i-v-o-detection-k-set-lateral-flow-assay-product/ (accessed on 5 May 2025).
Lee CH, Cao H, Jiang S, Wong TT, Tse CW, Ho PL. Inoculum Size and False-Positive Detection of NDM- and OXA-48-Type Carbapenemases Using Two Multiplex Lateral Flow Assays. Diagnostics (Basel). 2024;14(12):1274-1285.
doi: 10.3390/diagnostics14121274.
Benhadid-Brahmi Y, Amaris Hobson C, Abdelmoumene L, Jaouen E, Magnan M, Gits-Muselli M, et al. Evaluation of phenotypic and genotypic methods for detecting KPC variants. Antimicrob Agents Chemother. 2025;69(5):e0008225. doi: 10.1128/aac.00082-25.
Sun H, Zhang Q, Wang R, Wang H, Wong YT, Wang M, et al. Resensitizing carbapenem- and colistin-resistant bacteria to antibiotics using auranofin. Nat. Commun. 2020;11: 5263-5276.
Potron A, Fournier D, Emeraud C, Triponney P, Plésiat P, Naas T, Dortet L. Evaluation of the Immunochromatographic NG-Test Carba 5 for Rapid Identification of Carbapenemase in Nonfermenters. Antimicrob. Agents Chemother. 2019; 63: e00968-19
Bodendoerfer E, Keller PM, Mancini S. Rapid Identification of NDM-, KPC-, IMP-, VIM- and OXA-48-like CarbapenemaseProducing Enterobacteriales from Blood Cultures by a Multiplex Lateral Flow Immunoassay. J. Antimicrob. Chemother. 2019; 74: 1749-1751.
Giordano L, Fiori B, D’Inzeo T, Parisi G, Liotti FM, Menchinelli G, et al. Simplified Testing Method for Direct Detection of Carbapenemase-Producing Organisms from Positive Blood Cultures Using the NG-Test Carba 5 Assay. Antimicrob. Agents Chemother. 2019; 63: e00550-19.
Takissian J, Bonnin RA, Naas T, Dortet L. NG-Test Carba 5 for Rapid Detection of Carbapenemase-Producing Enterobacterales from Positive Blood Cultures. Antimicrob. Agents Chemother. 2019; 63: e00011-19.
Jenkins S, Ledeboer NA, Westblade LF, Burnham CAD, Faron ML, Bergman Y, et al. Evaluation of NG-Test Carba 5 for Rapid Phenotypic Detection and Differentiation of Five Common Carbapenemase Families: Results of a Multicenter Clinical Evaluation. J. Clin. Microbiol. 2020; 58: e00344-20.
Huang YT, Kuo YW, Lee NY, Tien N, Liao CH, Teng LJ, et al. Evaluating NG-Test CARBA 5 Multiplex Immunochromatographic and Cepheid Xpert CARBA-R Assays among Carbapenem-Resistant Enterobacterales Isolates Associated with Bloodstream Infection. Microbiol. Spectr. 2022; 10: e01728-21.
Liu Z, Bai L, Liu J, Lei J, Gao X, Tenover FC, et al. Parallel Validation of the NG-Test Carba 5 and the Xpert Carba-R for Detection and Characterization of Carbapenem-Resistant Enterobacterales Causing Bloodstream Infections. J. Mol. Diagn. 2021; 23: 1007-1014.
Yoon J, Kim CH, Yoon SY, Lim CS, Lee CK. Application of a Multiplex Immunochromatographic Assay for Rapid Identification of Carbapenemases in a Clinical Microbiology Laboratory: Performance and Turn-around-Time Evaluation of NG-Test Carba 5. BMC Microbiol. 2021; 21: 260-267.
Cuffari S, Aiezza N, Antonelli A, Giani T, Rossolini GM. Evaluation of three commercial lateral flow immunoassays for the detection of KPC, VIM, NDM, IMP and OXA-48-like carbapenemases. J Antimicrob Chemother. 2024;79(10):2724-2727. doi: 10.1093/jac/dkae262.
Referanslar
Logan LK, Weinstein RA. The epidemiology of carbapenem resistant Enterobacteriaceae: the impact and evolution of a global menace. J Infect Dis. 2017;215:28-36. doi:10.1093/infdis/jiw282
Lupo A, Papp-Wallace KM, Sendi P, Bonomo RA, Endimiani A. Non-phenotypic tests to detect and characterize antibiotic resistance mechanisms in Enterobacteriaceae. Diagn Microbiol Infect Dis. 2013;77: 179 -194.
doi:10.1016/j.diagmicrobio.2013.06.001.
Rood IGH, Li Q. Review: molecular detection of extended spectrum-beta-lactamase- and carbapenemase-producing Enterobacteriaceae in a clinical setting. Diagn Microbiol Infect Dis. 2017;89:245-250. doi:10.1016/j.diagmicrobio.2017.07.013.
Tamma PD, Simner PJ. Phenotypic Detection of Carbapenemase-Producing Organisms from Clinical Isolates. J Clin Microbiol. 2018; 56(11):e01140-58. doi: 10.1128/JCM.01140-18.
Goodman KE, Simner PJ, Tamma PD, Milstone AM. Infection control implications of heterogeneous resistance mechanisms in carbapenem-resistant Enterobacteriaceae (CRE). Expert Rev Anti Infect Ther. 2016; 14:95-108.
doi:10.1586/14787210.2016.1106940.
Boutal H, Moguet C, Pommiès L, Simon S, Naas T, Volland H. The Revolution of Lateral Flow Assay in the Field of AMR Detection. Diagnostics (Basel). 2022;12(7):1744-70 doi: 10.3390/diagnostics12071744.
Land KJ, Boeras DI, Chen XS, Ramsay AR, Peeling RW REASSURED Diagnostics to Inform Disease Control Strategies, Strengthen Health Systems and Improve Patient Outcomes. Nat. Microbiol. 2019;4:46-54.
Hamprecht A, Vehreschild JJ, Seifert H, Saleh A. Rapid Detection of NDM, KPC and OXA-48 Carbapenemases Directly from Positive Blood Cultures Using a New Multiplex Immunochromatographic Assay. PLoS ONE 2018; 13: e0204157.
Glupczynski Y, Evrard S, Huang TD, Bogaerts P. Evaluation of the RESIST-4 K-SeT Assay, a Multiplex Immunochromatographic Assay for the Rapid Detection of OXA-48-Like, KPC, VIM and NDM Carbapenemases. J. Antimicrob. Chemother. 2019; 74: 1284-1287.
Hong J, Kang D, Kim D. Performance Evaluation of the Newly Developed In Vitro Rapid Diagnostic Test for Detecting OXA-48-Like, KPC-, NDM-, VIM- and IMP-Type Carbapenemases: The RESIST-5 O.K.N.V.I. Multiplex Lateral Flow Assay. Antibiotics 2021; 10: 460.
El Kettani A, Maaloum F, Nzoyikorera N, Khalis M, Katfy K, Belabbes H, et alEvaluation of the Performances of the Rapid Test RESIST-5 O.O.K.N.V Used for the Detection of Carbapenemases-Producing Enterobacterales. Antibiotics. 2021; 10: 953-62.
Han R, Guo Y, Peng M, Shi Q, Wu S, Yang Y, et al. Evaluation of the Immunochromatographic NG-Test Carba 5, RESIST-5 O.O.K.N.V., and IMP K-SeT for Rapid Detection of KPC-, NDM-, IMP-, VIM-Type, and OXA-48-like Carbapenemase Among Enterobacterales. Front. Microbiol. 2021; 11: 3296-3303.
Boutal H, Vogel A, Bernabeu S, Devilliers K, Creton E, Cotellon G, et al. A Multiplex Lateral Flow Immunoassay for the Rapid Identification of NDM-, KPC-, IMP- and VIM-Type and OXA-48-like Carbapenemase-Producing Enterobacteriaceae. J Antimicrob Chemother 2018; 73: 909-915
Di Nardo F, Chiarello M, Cavalera S, Baggiani C, Anfossi L. Ten Years of Lateral Flow Immunoassay Technique Applications: Trends, Challenges and Future Perspectives. Sensors 2021; 21: 5185-5218.
Posthuma-Trumpie G.A, Korf J, van Amerongen A. Lateral Flow (Immuno)assay: Its Strengths, Weaknesses, Opportunities and Threats. A Literature Survey. Anal. Bioanal. Chem. 2009; 393: 569-582.
Park J. An Optimized Colorimetric Readout Method for Lateral Flow Immunoassays. Sensors 2018; 18: 4084-4093.
Xiao R, Lu L, Rong Z, Wang C, Peng Y, Wang F, et al. Portable and Multiplexed Lateral Flow Immunoassay Reader Based on SERS for Highly Sensitive Point-of-Care Testing. Biosens. Bioelectron. 2020; 168: 112524.
Koczula KM, Gallotta A. Lateral Flow Assays. Essays Biochem. 2016; 60: 111-120.
Andryukov BG. Six Decades of Lateral Flow Immunoassay: From Determining Metabolic Markers to Diagnosing COVID-19. AIMS Microbiol. 2020; 6: 280-304.
Tarlton NJ, Wallace MA, Potter RF, Zhang K, Dantas G, Dubberke ER, Burnham CD, Yarbrough ML. Evaluation of the NG-Test CARBA 5 Lateral Flow Assay with an IMP-27-Producing Morganella morganii and Other Morganellaceae. Microbiol. Spectr. 2023; 11: e0079323.
NG-Biotech Laboratories. NG-Test CARBA 5 Package Insert. ENO 035CAR Rev: 220125 Guipry, France. 2022. Available online: https://ngbiotech.com/amr-doc/Instructions_for_use_NG-Test-CARBA-5_for_the_United_States_v220125.pdf (accessed on 5 May 2025).
Genobio Pharmaceutical. Carbapenem-Resistant K.N.I.V.O. Detection K-Set Product Insert. 2021. Available online: https: //www.genobio-pharm.com/carbapenem-resistant-k-n-i-v-o-detection-k-set-lateral-flow-assay-product/ (accessed on 5 May 2025).
Lee CH, Cao H, Jiang S, Wong TT, Tse CW, Ho PL. Inoculum Size and False-Positive Detection of NDM- and OXA-48-Type Carbapenemases Using Two Multiplex Lateral Flow Assays. Diagnostics (Basel). 2024;14(12):1274-1285.
doi: 10.3390/diagnostics14121274.
Benhadid-Brahmi Y, Amaris Hobson C, Abdelmoumene L, Jaouen E, Magnan M, Gits-Muselli M, et al. Evaluation of phenotypic and genotypic methods for detecting KPC variants. Antimicrob Agents Chemother. 2025;69(5):e0008225. doi: 10.1128/aac.00082-25.
Sun H, Zhang Q, Wang R, Wang H, Wong YT, Wang M, et al. Resensitizing carbapenem- and colistin-resistant bacteria to antibiotics using auranofin. Nat. Commun. 2020;11: 5263-5276.
Potron A, Fournier D, Emeraud C, Triponney P, Plésiat P, Naas T, Dortet L. Evaluation of the Immunochromatographic NG-Test Carba 5 for Rapid Identification of Carbapenemase in Nonfermenters. Antimicrob. Agents Chemother. 2019; 63: e00968-19
Bodendoerfer E, Keller PM, Mancini S. Rapid Identification of NDM-, KPC-, IMP-, VIM- and OXA-48-like CarbapenemaseProducing Enterobacteriales from Blood Cultures by a Multiplex Lateral Flow Immunoassay. J. Antimicrob. Chemother. 2019; 74: 1749-1751.
Giordano L, Fiori B, D’Inzeo T, Parisi G, Liotti FM, Menchinelli G, et al. Simplified Testing Method for Direct Detection of Carbapenemase-Producing Organisms from Positive Blood Cultures Using the NG-Test Carba 5 Assay. Antimicrob. Agents Chemother. 2019; 63: e00550-19.
Takissian J, Bonnin RA, Naas T, Dortet L. NG-Test Carba 5 for Rapid Detection of Carbapenemase-Producing Enterobacterales from Positive Blood Cultures. Antimicrob. Agents Chemother. 2019; 63: e00011-19.
Jenkins S, Ledeboer NA, Westblade LF, Burnham CAD, Faron ML, Bergman Y, et al. Evaluation of NG-Test Carba 5 for Rapid Phenotypic Detection and Differentiation of Five Common Carbapenemase Families: Results of a Multicenter Clinical Evaluation. J. Clin. Microbiol. 2020; 58: e00344-20.
Huang YT, Kuo YW, Lee NY, Tien N, Liao CH, Teng LJ, et al. Evaluating NG-Test CARBA 5 Multiplex Immunochromatographic and Cepheid Xpert CARBA-R Assays among Carbapenem-Resistant Enterobacterales Isolates Associated with Bloodstream Infection. Microbiol. Spectr. 2022; 10: e01728-21.
Liu Z, Bai L, Liu J, Lei J, Gao X, Tenover FC, et al. Parallel Validation of the NG-Test Carba 5 and the Xpert Carba-R for Detection and Characterization of Carbapenem-Resistant Enterobacterales Causing Bloodstream Infections. J. Mol. Diagn. 2021; 23: 1007-1014.
Yoon J, Kim CH, Yoon SY, Lim CS, Lee CK. Application of a Multiplex Immunochromatographic Assay for Rapid Identification of Carbapenemases in a Clinical Microbiology Laboratory: Performance and Turn-around-Time Evaluation of NG-Test Carba 5. BMC Microbiol. 2021; 21: 260-267.
Cuffari S, Aiezza N, Antonelli A, Giani T, Rossolini GM. Evaluation of three commercial lateral flow immunoassays for the detection of KPC, VIM, NDM, IMP and OXA-48-like carbapenemases. J Antimicrob Chemother. 2024;79(10):2724-2727. doi: 10.1093/jac/dkae262.
