Diagnostic value comparative analysis of the commercial kits for the detection of SARS-CoV-2 in clinical samples: a systematic review and meta-analysis
-
Sepide Kadivarian
,
Mosayeb Mosayeb
,
Sara Kooti
,
Shirin Dashtbin
,
Somayeh Hosseinabadi
,
Ramin Abiri
,
Amirhooshang Alvand
Abstract
Background and Objectives: Rapid and accurate identification of suspicious SARS-CoV-2 patients is essential in controlling the infection. Numerous commercial kits are developed which target diverse regions of the SARS-CoV-2 virus genome. This systematic review addresses the lack of comprehensive analyses comparing the diagnostic value of commercial kits for SARS-CoV-2 detection. We aimed to compare diagnostic value of commercial SARS-CoV-2 kits in clinical samples using a systematic review and meta-analysis method.
Materials and Methods: A comprehensive search was conducted on main databases of Medline (PubMed), Embase, Web of Science and Scopus from 2019 to October 2021 using the appropriate keywords. Systematic Reviews and Meta-Analysis guideline PRISMA checklist was used to select eligible studies.
Results: The most frequent introduced kits were from USA (33 cases) and China (27). Among all studies, 11, 9 and 7 papers had assessed FDA –CDC, Sansure and Allplex kits, respectively. The majority of the kits were based on RT-PCR (52 cases) and the most frequent genes target was N protein (63 cases). The overall sensitivity of the kits was 80.5%. The lowest sensitivity was reported for Daan Kit, while the highest sensitivity was seen for many kits. The specificity of the kits ranged from 87.9% to 99.8% and the overall specificity was 97.9%. Both PPV and NPV of the kits ranged from 87.9% to 99.8% for PPV and 82.9% to 99.8% for NPV.
Conclusion: Based on DOR obtained from three different formulas, GeneFinder, InBios, NxTAG, Simplexa and FDA-CDC kit have better detection performance. The GeneFinder Kit appears to be among the more suitable options regarding cost-effectiveness for each reaction.
1. Oran DP, Topol EJ. Prevalence of Asymptomatic SARS-CoV-2 infection : A narrative review. Ann Intern Med 2020; 173: 362-367.
2. Syal K. Guidelines on newly identified limitations of diagnostic tools for COVID-19 and consequences. J Med Virol 2021; 93: 1837-1842.
3. Khailany RA, Safdar M, Ozaslan M. Genomic characterization of a novel SARS-CoV-2. Gene Rep 2020; 19: 100682.
4. Udugama B, Kadhiresan P, Kozlowski HN, Malekjahani A, Osborne M, Li VYC, et al. Diagnosing COVID-19: The Disease and Tools for Detection. ACS Nano 2020; 14: 3822-3835.
5. McInnes MDF, Moher D, Thombs BD, McGrath TA, Bossuyt PM, Clifford T, et al. Preferred reporting items for a systematic review and Meta-analysis of diagnostic test accuracy studies: The PRISMA-DTA statement. JAMA 2018; 319: 388-396.
6. Leeflang MM. Systematic reviews and meta-analyses of diagnostic test accuracy. Clin Microbiol Infect 2014; 20: 105-113.
7. Alaifan T, Altamimi A, Obeid D, Alshehri T, Almatrrouk S, Albarrag A. SARS-CoV-2 direct real-time polymerase chain reaction testing in laboratories with shortage challenges. Future Virol 2021; 16: 133-139.
8. Guo JJ, Yu YH, Ma XY, Liu YN, Fang Q, Qu P, et al. A multiple-center clinical evaluation of a new real-time reverse transcriptase PCR diagnostic kit for SARS-CoV-2. Future Virol 2020; 10.2217/fvl-2020-0299.
9. Freire-Paspuel B, Vega-Mariño P, Velez A, Cruz M, Perez F, Garcia-Bereguiain MA. Analytical and clinical comparison of Viasure (CerTest Biotec) and 2019-nCoV CDC (IDT) RT-qPCR kits for SARS-CoV2 diagnosis. Virology 2021; 555: 111.
10. Wang M, Chen D, Wu W, Tang H, Kan L, Zong Z, et al. Analytical performance evaluation of five RT-PCR kits for severe acute respiratory syndrome coronavirus 2. J Clin Lab Anal 2021; 35(1): e23643.
11. Goldenberger D, Leuzinger K, Sogaard KK, Gosert R, Roloff T, Naegele K, et al. Brief validation of the novel GeneXpert Xpress SARS-CoV-2 PCR assay. J Virol Methods 2020; 284: 113925.
12. Nagura-Ikeda M, Imai K, Tabata S, Miyoshi K, Murahara N, Mizuno T, et al. Clinical Evaluation of Self-Collected Saliva by Quantitative Reverse Transcription-PCR (RT-qPCR), Direct RT-qPCR, Reverse Transcription-Loop-Mediated Isothermal Amplification, and a Rapid Antigen Test To Diagnose COVID-19. J Clin Microbiol 2020; 58(9): e01438-20.
13. Chen JH, Yip CC, Chan JF, Poon RW, To KK, Chan KH, et al. Clinical Performance of the Luminex NxTAG CoV Extended Panel for SARS-CoV-2 Detection in Nasopharyngeal Specimens from COVID-19 Patients in Hong Kong. J Clin Microbiol 2020; 58(8): e00936-20.
14. Matsumura Y, Shimizu T, Noguchi T, Nakano S, Yamamoto M, Nagao M. Comparison of 12 Molecular detection assays for severe acute Respiratory syndrome Coronavirus 2 (SARS-CoV-2). J Mol Diagn 2021; 23: 164-170.
15. Zhen W, Manji R, Smith E, Berry GJ. Comparison of Four Molecular in vitro diagnostic assays for the detection of SARS-CoV-2 in Nasopharyngeal specimens. J Clin Microbiol 2020; 58(8): e00743-20.
16. van Kasteren PB, van der Veer B, van den Brink S, Wijsman L, de Jonge J, van den Brandt A, et al. Comparison of seven commercial RT-PCR diagnostic kits for COVID-19. J Clin Virol 2020; 128: 104412.
17. Lu Y, Li L, Ren S, Liu X, Zhang L, Li W, et al. Comparison of the diagnostic efficacy between two PCR test kits for SARS-CoV-2 nucleic acid detection. J Clin Lab Anal 2020; 34(10): e23554.
18. Pasomsub E, Watcharananan SP, Boonyawat K, Janchompoo P, Wongtabtim G, Suksuwan W, et al. Saliva sample as a non-invasive specimen for the diagnosis of coronavirus disease 2019: a cross-sectional study. Clin Microbiol Infect 2021; 27(2): 285.e1-285.e4.
19. Haq F, Sharif S, Khurshid A, Ikram A, Shabbir I, Salman M, et al. Reverse transcriptase loop-mediated isothermal amplification (RT-LAMP)-based diagnosis: A potential alternative to quantitative real-time PCR based detection of the novel SARS-COV-2 virus. Saudi J Biol Sci 2021; 28: 942-947.
20. Freire-Paspuel B, Garcia-Bereguiain MA. Poor sensitivity of "AccuPower SARS-CoV-2 real time RT-PCR kit (Bioneer, South Korea)". Virol J 2020; 17: 178.
21. Freire-Paspuel B, Garcia-Bereguiain MA. Low clinical performance of the Isopollo COVID-19 detection kit (M Monitor, South Korea) for RT-LAMP SARS-CoV-2 diagnosis: A call for action against low quality products for developing countries. Int J Infect Dis 2021; 104: 303-305.
22. Sarıgül F, Doluca O, Akhan S, Sayan M. Investigation of compatibility of severe acute respiratory syndrome coronavirus 2 reverse transcriptase-PCR kits containing different gene targets during coronavirus disease 2019 pandemic. Future Virol 2020; 15: 515-524.
23. Alcoba-Florez J, Gil-Campesino H, García-Martínez de Artola D, Díez-Gil O, Valenzuela-Fernández A, González-Montelongo R, et al. Increasing SARS-CoV-2 RT-qPCR testing capacity by sample pooling. Int J Infect Dis 2021; 103: 19-22.
24. Zou J, Zhi S, Chen M, Su X, Kang L, Li C, et al. Heat inactivation decreases the qualitative real-time RT-PCR detection rates of clinical samples with high cycle threshold values in COVID-19. Diagn Microbiol Infect Dis 2020; 98: 115109.
25. Visseaux B, Le Hingrat Q, Collin G, Ferré V, Storto A, Ichou H, et al. Evaluation of the RealStar® SARS-CoV-2 RT-PCR kit RUO performances and limit of detection. J Clin Virol 2020; 129: 104520.
26. Kitagawa Y, Orihara Y, Kawamura R, Imai K, Sakai J, Tarumoto N, et al. Evaluation of rapid diagnosis of novel coronavirus disease (COVID-19) using loop-mediated isothermal amplification. J Clin Virol 2020; 129: 104446.
27. Freire-Paspuel B, Vega-Mariño P, Velez A, Castillo P, Cruz M, Garcia-Bereguiain MA. Evaluation of nCoV-QS (MiCo BioMed) for RT-qPCR detection of SARS-CoV-2 from nasopharyngeal samples using CDC FDA EUA qPCR kit as a gold standard: An example of the need of validation studies. J Clin Virol 2020; 128: 104454.
28. Wen D, Yang S, Li G, Xuan Q, Guo W, Wu W. Sample-to-Answer and routine Real-Time RT-PCR: A comparison of different platforms for SARS-CoV-2 detection. J Mol Diagn 2021; 23: 665-670.
29. Sasaki T, Inoue O, Ogihara S, Kubokawa K, Oishi S, Shirai T, et al. Detection of SARS-CoV-2 RNA Using RT-qPCR in saliva samples and Nasopharyngeal, Lingual, and buccal mucosal swabs. Jpn J Infect Dis 2022; 75: 102-104.
30. Tedim AP, Almansa R, Domínguez-Gil M, González-Rivera M, Micheloud D, Ryan P, et al. Comparison of real-time and droplet digital PCR to detect and quantify SARS-CoV-2 RNA in plasma. Eur J Clin Invest 2021; 51(6): e13501.
31. Mollaei HR, Afshar AA, Kalantar-Neyestanaki D, Fazlalipour M, Aflatoonian B. Comparison five primer sets from different genome region of COVID-19 for detection of virus infection by conventional RT-PCR. Iran J Microbiol 2020; 12: 185-193.
32. Lee CJ, Shin W, Mun S, Yu M, Choi YB, Kim DH, et al. Diagnostic evaluation of qRT-PCR-based kit and dPCR-based kit for COVID-19. Genes Genomics 2021; 43: 1277-1288.
33. Hernández C, Florez C, Castañeda S, Ballesteros N, Martínez D, Castillo A, et al. Evaluation of the diagnostic performance of nine commercial RT-PCR kits for the detection of SARS-CoV-2 in Colombia. J Med Virol 2021; 93: 5618-5622.
34. Chung YS, Lee NJ, Woo SH, Kim JM, Kim HM, Jo HJ, et al. Validation of real-time RT-PCR for detection of SARS-CoV-2 in the early stages of the COVID-19 outbreak in the Republic of Korea. Sci Rep 2021; 11: 14817.
35. Roy S, Paul SK, Barman TK, Ahmed S, Haque N, Mazid R, et al. SARS-CoV-2 Detection using Real Time PCR by a Commercial Diagnostic Kit. Mymensingh Med J 2020; 29: 596-600.
36. Fukumoto T, Iwasaki S, Fujisawa S, Hayasaka K, Sato K, Oguri S, et al. Efficacy of a novel SARS-CoV-2 detection kit without RNA extraction and purification. Int J Infect Dis 2020; 98: 16-17.
37. Freire-Paspuel B, Garcia-Bereguiain MA. Analytical and Clinical Evaluation of "AccuPower SARS-CoV-2 Multiplex RT-PCR kit (Bioneer, South Korea)" and "Allplex 2019-nCoV Assay (Seegene, South Korea)" for SARS-CoV-2 RT-PCR Diagnosis: Korean CDC EUA as a Quality control proxy for developing countries. Front Cell Infect Microbiol 2021; 11: 630552.
38. Reijns MAM, Thompson L, Acosta JC, Black HA, Sanchez-Luque FJ, Diamond A, et al. A sensitive and affordable multiplex RT-qPCR assay for SARS-CoV-2 detection. PLoS Biol 2020; 18(12): e3001030.
39. Freire-Paspuel B, Garcia-Bereguiain MA. Clinical Performance and analytical sensitivity of three SARS-CoV-2 Nucleic acid diagnostic tests. Am J Trop Med Hyg 2021; 104: 1516-1518.
40. Lu R, Wu X, Wan Z, Li Y, Jin X, Zhang C. A novel reverse transcription Loop-Mediated isothermal Amplification method for rapid detection of SARS-CoV-2. Int J Mol Sci 2020; 21: 2826.
41. Hur KH, Park K, Lim Y, Jeong YS, Sung H, Kim MN. Evaluation of four commercial kits for SARS-CoV-2 Real-Time Reverse-Transcription Polymerase Chain Reaction Approved by Emergency-Use-Authorization in Korea. Front Med (Lausanne) 2020; 7: 521.
42. Tsang HF, Leung WMS, Chan LWC, Cho WCS, Wong SCC. Performance comparison of the Cobas® Liat® and Cepheid® GeneXpert® systems on SARS-CoV-2 detection in nasopharyngeal swab and posterior oropharyngeal saliva. Expert Rev Mol Diagn 2021; 21: 515-518.
43. Moore NM, Li H, Schejbal D, Lindsley J, Hayden MK. Comparison of two commercial Molecular tests and a Laboratory-Developed Modification of the CDC 2019-nCoV Reverse Transcriptase PCR Assay for the detection of SARS-CoV-2. J Clin Microbiol 2020; 58(8): e00938-20.
44. Gupta E, Padhi A, Khodare A, Agarwal R, Ramachandran K, Mehta V, et al. Pooled RNA sample reverse transcriptase real time PCR assay for SARS CoV-2 infection: A reliable, faster and economical method. PLoS One 2020; 15(7): e0236859.
45. Schermer B, Fabretti F, Damagnez M, Di Cristanziano V, Heger E, Arjune S, et al. Rapid SARS-CoV-2 testing in primary material based on a novel multiplex RT-LAMP assay. PLoS One 2020; 15(11): e0238612.
46. Szymczak WA, Goldstein DY, Orner EP, Fecher RA, Yokoda RT, Skalina KA, et al. Utility of Stool PCR for the diagnosis of COVID-19: Comparison of two commercial platforms. J Clin Microbiol 2020; 58(9): e01369-20.
47. Goldfarb DM, Tilley P, Al-Rawahi GN, Srigley JA, Ford G, Pedersen H, et al. Self-Collected saline gargle samples as an Alternative to Health care Worker-Collected Nasopharyngeal swabs for COVID-19 diagnosis in Outpatients. J Clin Microbiol 2021; 59(4): e02427-20.
48. Fan J, Yu F, Wang X, Zou Q, Lou B, Xie G, et al. Hock-a-loogie saliva as a diagnostic specimen for SARS-CoV-2 by a PCR-based assay: A diagnostic validity study. Clin Chim Acta 2020; 511: 177-180.
49. Nawattanapaiboon K, Pasomsub E, Prombun P, Wongbunmak A, Jenjitwanich A, Mahasupachai P, et al. Colorimetric reverse transcription loop-mediated isothermal amplification (RT-LAMP) as a visual diagnostic platform for the detection of the emerging coronavirus SARS-CoV-2. Analyst 2021; 146: 471-477.
50. Lim B, Ratcliff J, Nawrot DA, Yu Y, Sanghani HR, Hsu CC, et al. Clinical validation of optimised RT-LAMP for the diagnosis of SARS-CoV-2 infection. Sci Rep 2021; 11: 16193.
51. Roumani F, Azinheiro S, Sousa H, Sousa A, Timóteo M, Varandas T, et al. Optimization and clinical evaluation of a Multi-Target Loop-Mediated isothermal amplification assay for the detection of SARS-CoV-2 in Nasopharyngeal samples. Viruses 2021; 13: 940.
52. Huang WE, Lim B, Hsu CC, Xiong D, Wu W, Yu Y, et al. RT-LAMP for rapid diagnosis of coronavirus SARS-CoV-2. Microb Biotechnol 2020; 13: 950-961.
53. Böger B, Fachi MM, Vilhena RO, Cobre AF, Tonin FS, Pontarolo R. Systematic review with meta-analysis of the accuracy of diagnostic tests for COVID-19. Am J Infect Control 2021; 49: 21-29.
54. Kim M, Kweon S, Lee J, Baek S, Jeon B, Yoo H, et al. Weekly report on the COVID-19 situation in the Republic of Korea (As of March 28, 2020). Public Health Weekly Report 2020; 13: 792-806.
55. Xie JW, He Y, Zheng YW, Wang M, Lin Y, Lin L-R. Diagnostic accuracy of rapid antigen test for SARS-CoV-2: A systematic review and meta-analysis of 166,943 suspected COVID-19 patients. Microbiol Res 2022; 265: 127185.
56. Vilca-Alosilla JJ, Candia-Puma MA, Coronel-Monje K, Goyzueta-Mamani LD, Galdino AS, Machado-de-Ávila RA, et al. A systematic review and meta-analysis comparing the diagnostic accuracy tests of COVID-19. Diagnostics (Basel) 2023; 13: 1549.
2. Syal K. Guidelines on newly identified limitations of diagnostic tools for COVID-19 and consequences. J Med Virol 2021; 93: 1837-1842.
3. Khailany RA, Safdar M, Ozaslan M. Genomic characterization of a novel SARS-CoV-2. Gene Rep 2020; 19: 100682.
4. Udugama B, Kadhiresan P, Kozlowski HN, Malekjahani A, Osborne M, Li VYC, et al. Diagnosing COVID-19: The Disease and Tools for Detection. ACS Nano 2020; 14: 3822-3835.
5. McInnes MDF, Moher D, Thombs BD, McGrath TA, Bossuyt PM, Clifford T, et al. Preferred reporting items for a systematic review and Meta-analysis of diagnostic test accuracy studies: The PRISMA-DTA statement. JAMA 2018; 319: 388-396.
6. Leeflang MM. Systematic reviews and meta-analyses of diagnostic test accuracy. Clin Microbiol Infect 2014; 20: 105-113.
7. Alaifan T, Altamimi A, Obeid D, Alshehri T, Almatrrouk S, Albarrag A. SARS-CoV-2 direct real-time polymerase chain reaction testing in laboratories with shortage challenges. Future Virol 2021; 16: 133-139.
8. Guo JJ, Yu YH, Ma XY, Liu YN, Fang Q, Qu P, et al. A multiple-center clinical evaluation of a new real-time reverse transcriptase PCR diagnostic kit for SARS-CoV-2. Future Virol 2020; 10.2217/fvl-2020-0299.
9. Freire-Paspuel B, Vega-Mariño P, Velez A, Cruz M, Perez F, Garcia-Bereguiain MA. Analytical and clinical comparison of Viasure (CerTest Biotec) and 2019-nCoV CDC (IDT) RT-qPCR kits for SARS-CoV2 diagnosis. Virology 2021; 555: 111.
10. Wang M, Chen D, Wu W, Tang H, Kan L, Zong Z, et al. Analytical performance evaluation of five RT-PCR kits for severe acute respiratory syndrome coronavirus 2. J Clin Lab Anal 2021; 35(1): e23643.
11. Goldenberger D, Leuzinger K, Sogaard KK, Gosert R, Roloff T, Naegele K, et al. Brief validation of the novel GeneXpert Xpress SARS-CoV-2 PCR assay. J Virol Methods 2020; 284: 113925.
12. Nagura-Ikeda M, Imai K, Tabata S, Miyoshi K, Murahara N, Mizuno T, et al. Clinical Evaluation of Self-Collected Saliva by Quantitative Reverse Transcription-PCR (RT-qPCR), Direct RT-qPCR, Reverse Transcription-Loop-Mediated Isothermal Amplification, and a Rapid Antigen Test To Diagnose COVID-19. J Clin Microbiol 2020; 58(9): e01438-20.
13. Chen JH, Yip CC, Chan JF, Poon RW, To KK, Chan KH, et al. Clinical Performance of the Luminex NxTAG CoV Extended Panel for SARS-CoV-2 Detection in Nasopharyngeal Specimens from COVID-19 Patients in Hong Kong. J Clin Microbiol 2020; 58(8): e00936-20.
14. Matsumura Y, Shimizu T, Noguchi T, Nakano S, Yamamoto M, Nagao M. Comparison of 12 Molecular detection assays for severe acute Respiratory syndrome Coronavirus 2 (SARS-CoV-2). J Mol Diagn 2021; 23: 164-170.
15. Zhen W, Manji R, Smith E, Berry GJ. Comparison of Four Molecular in vitro diagnostic assays for the detection of SARS-CoV-2 in Nasopharyngeal specimens. J Clin Microbiol 2020; 58(8): e00743-20.
16. van Kasteren PB, van der Veer B, van den Brink S, Wijsman L, de Jonge J, van den Brandt A, et al. Comparison of seven commercial RT-PCR diagnostic kits for COVID-19. J Clin Virol 2020; 128: 104412.
17. Lu Y, Li L, Ren S, Liu X, Zhang L, Li W, et al. Comparison of the diagnostic efficacy between two PCR test kits for SARS-CoV-2 nucleic acid detection. J Clin Lab Anal 2020; 34(10): e23554.
18. Pasomsub E, Watcharananan SP, Boonyawat K, Janchompoo P, Wongtabtim G, Suksuwan W, et al. Saliva sample as a non-invasive specimen for the diagnosis of coronavirus disease 2019: a cross-sectional study. Clin Microbiol Infect 2021; 27(2): 285.e1-285.e4.
19. Haq F, Sharif S, Khurshid A, Ikram A, Shabbir I, Salman M, et al. Reverse transcriptase loop-mediated isothermal amplification (RT-LAMP)-based diagnosis: A potential alternative to quantitative real-time PCR based detection of the novel SARS-COV-2 virus. Saudi J Biol Sci 2021; 28: 942-947.
20. Freire-Paspuel B, Garcia-Bereguiain MA. Poor sensitivity of "AccuPower SARS-CoV-2 real time RT-PCR kit (Bioneer, South Korea)". Virol J 2020; 17: 178.
21. Freire-Paspuel B, Garcia-Bereguiain MA. Low clinical performance of the Isopollo COVID-19 detection kit (M Monitor, South Korea) for RT-LAMP SARS-CoV-2 diagnosis: A call for action against low quality products for developing countries. Int J Infect Dis 2021; 104: 303-305.
22. Sarıgül F, Doluca O, Akhan S, Sayan M. Investigation of compatibility of severe acute respiratory syndrome coronavirus 2 reverse transcriptase-PCR kits containing different gene targets during coronavirus disease 2019 pandemic. Future Virol 2020; 15: 515-524.
23. Alcoba-Florez J, Gil-Campesino H, García-Martínez de Artola D, Díez-Gil O, Valenzuela-Fernández A, González-Montelongo R, et al. Increasing SARS-CoV-2 RT-qPCR testing capacity by sample pooling. Int J Infect Dis 2021; 103: 19-22.
24. Zou J, Zhi S, Chen M, Su X, Kang L, Li C, et al. Heat inactivation decreases the qualitative real-time RT-PCR detection rates of clinical samples with high cycle threshold values in COVID-19. Diagn Microbiol Infect Dis 2020; 98: 115109.
25. Visseaux B, Le Hingrat Q, Collin G, Ferré V, Storto A, Ichou H, et al. Evaluation of the RealStar® SARS-CoV-2 RT-PCR kit RUO performances and limit of detection. J Clin Virol 2020; 129: 104520.
26. Kitagawa Y, Orihara Y, Kawamura R, Imai K, Sakai J, Tarumoto N, et al. Evaluation of rapid diagnosis of novel coronavirus disease (COVID-19) using loop-mediated isothermal amplification. J Clin Virol 2020; 129: 104446.
27. Freire-Paspuel B, Vega-Mariño P, Velez A, Castillo P, Cruz M, Garcia-Bereguiain MA. Evaluation of nCoV-QS (MiCo BioMed) for RT-qPCR detection of SARS-CoV-2 from nasopharyngeal samples using CDC FDA EUA qPCR kit as a gold standard: An example of the need of validation studies. J Clin Virol 2020; 128: 104454.
28. Wen D, Yang S, Li G, Xuan Q, Guo W, Wu W. Sample-to-Answer and routine Real-Time RT-PCR: A comparison of different platforms for SARS-CoV-2 detection. J Mol Diagn 2021; 23: 665-670.
29. Sasaki T, Inoue O, Ogihara S, Kubokawa K, Oishi S, Shirai T, et al. Detection of SARS-CoV-2 RNA Using RT-qPCR in saliva samples and Nasopharyngeal, Lingual, and buccal mucosal swabs. Jpn J Infect Dis 2022; 75: 102-104.
30. Tedim AP, Almansa R, Domínguez-Gil M, González-Rivera M, Micheloud D, Ryan P, et al. Comparison of real-time and droplet digital PCR to detect and quantify SARS-CoV-2 RNA in plasma. Eur J Clin Invest 2021; 51(6): e13501.
31. Mollaei HR, Afshar AA, Kalantar-Neyestanaki D, Fazlalipour M, Aflatoonian B. Comparison five primer sets from different genome region of COVID-19 for detection of virus infection by conventional RT-PCR. Iran J Microbiol 2020; 12: 185-193.
32. Lee CJ, Shin W, Mun S, Yu M, Choi YB, Kim DH, et al. Diagnostic evaluation of qRT-PCR-based kit and dPCR-based kit for COVID-19. Genes Genomics 2021; 43: 1277-1288.
33. Hernández C, Florez C, Castañeda S, Ballesteros N, Martínez D, Castillo A, et al. Evaluation of the diagnostic performance of nine commercial RT-PCR kits for the detection of SARS-CoV-2 in Colombia. J Med Virol 2021; 93: 5618-5622.
34. Chung YS, Lee NJ, Woo SH, Kim JM, Kim HM, Jo HJ, et al. Validation of real-time RT-PCR for detection of SARS-CoV-2 in the early stages of the COVID-19 outbreak in the Republic of Korea. Sci Rep 2021; 11: 14817.
35. Roy S, Paul SK, Barman TK, Ahmed S, Haque N, Mazid R, et al. SARS-CoV-2 Detection using Real Time PCR by a Commercial Diagnostic Kit. Mymensingh Med J 2020; 29: 596-600.
36. Fukumoto T, Iwasaki S, Fujisawa S, Hayasaka K, Sato K, Oguri S, et al. Efficacy of a novel SARS-CoV-2 detection kit without RNA extraction and purification. Int J Infect Dis 2020; 98: 16-17.
37. Freire-Paspuel B, Garcia-Bereguiain MA. Analytical and Clinical Evaluation of "AccuPower SARS-CoV-2 Multiplex RT-PCR kit (Bioneer, South Korea)" and "Allplex 2019-nCoV Assay (Seegene, South Korea)" for SARS-CoV-2 RT-PCR Diagnosis: Korean CDC EUA as a Quality control proxy for developing countries. Front Cell Infect Microbiol 2021; 11: 630552.
38. Reijns MAM, Thompson L, Acosta JC, Black HA, Sanchez-Luque FJ, Diamond A, et al. A sensitive and affordable multiplex RT-qPCR assay for SARS-CoV-2 detection. PLoS Biol 2020; 18(12): e3001030.
39. Freire-Paspuel B, Garcia-Bereguiain MA. Clinical Performance and analytical sensitivity of three SARS-CoV-2 Nucleic acid diagnostic tests. Am J Trop Med Hyg 2021; 104: 1516-1518.
40. Lu R, Wu X, Wan Z, Li Y, Jin X, Zhang C. A novel reverse transcription Loop-Mediated isothermal Amplification method for rapid detection of SARS-CoV-2. Int J Mol Sci 2020; 21: 2826.
41. Hur KH, Park K, Lim Y, Jeong YS, Sung H, Kim MN. Evaluation of four commercial kits for SARS-CoV-2 Real-Time Reverse-Transcription Polymerase Chain Reaction Approved by Emergency-Use-Authorization in Korea. Front Med (Lausanne) 2020; 7: 521.
42. Tsang HF, Leung WMS, Chan LWC, Cho WCS, Wong SCC. Performance comparison of the Cobas® Liat® and Cepheid® GeneXpert® systems on SARS-CoV-2 detection in nasopharyngeal swab and posterior oropharyngeal saliva. Expert Rev Mol Diagn 2021; 21: 515-518.
43. Moore NM, Li H, Schejbal D, Lindsley J, Hayden MK. Comparison of two commercial Molecular tests and a Laboratory-Developed Modification of the CDC 2019-nCoV Reverse Transcriptase PCR Assay for the detection of SARS-CoV-2. J Clin Microbiol 2020; 58(8): e00938-20.
44. Gupta E, Padhi A, Khodare A, Agarwal R, Ramachandran K, Mehta V, et al. Pooled RNA sample reverse transcriptase real time PCR assay for SARS CoV-2 infection: A reliable, faster and economical method. PLoS One 2020; 15(7): e0236859.
45. Schermer B, Fabretti F, Damagnez M, Di Cristanziano V, Heger E, Arjune S, et al. Rapid SARS-CoV-2 testing in primary material based on a novel multiplex RT-LAMP assay. PLoS One 2020; 15(11): e0238612.
46. Szymczak WA, Goldstein DY, Orner EP, Fecher RA, Yokoda RT, Skalina KA, et al. Utility of Stool PCR for the diagnosis of COVID-19: Comparison of two commercial platforms. J Clin Microbiol 2020; 58(9): e01369-20.
47. Goldfarb DM, Tilley P, Al-Rawahi GN, Srigley JA, Ford G, Pedersen H, et al. Self-Collected saline gargle samples as an Alternative to Health care Worker-Collected Nasopharyngeal swabs for COVID-19 diagnosis in Outpatients. J Clin Microbiol 2021; 59(4): e02427-20.
48. Fan J, Yu F, Wang X, Zou Q, Lou B, Xie G, et al. Hock-a-loogie saliva as a diagnostic specimen for SARS-CoV-2 by a PCR-based assay: A diagnostic validity study. Clin Chim Acta 2020; 511: 177-180.
49. Nawattanapaiboon K, Pasomsub E, Prombun P, Wongbunmak A, Jenjitwanich A, Mahasupachai P, et al. Colorimetric reverse transcription loop-mediated isothermal amplification (RT-LAMP) as a visual diagnostic platform for the detection of the emerging coronavirus SARS-CoV-2. Analyst 2021; 146: 471-477.
50. Lim B, Ratcliff J, Nawrot DA, Yu Y, Sanghani HR, Hsu CC, et al. Clinical validation of optimised RT-LAMP for the diagnosis of SARS-CoV-2 infection. Sci Rep 2021; 11: 16193.
51. Roumani F, Azinheiro S, Sousa H, Sousa A, Timóteo M, Varandas T, et al. Optimization and clinical evaluation of a Multi-Target Loop-Mediated isothermal amplification assay for the detection of SARS-CoV-2 in Nasopharyngeal samples. Viruses 2021; 13: 940.
52. Huang WE, Lim B, Hsu CC, Xiong D, Wu W, Yu Y, et al. RT-LAMP for rapid diagnosis of coronavirus SARS-CoV-2. Microb Biotechnol 2020; 13: 950-961.
53. Böger B, Fachi MM, Vilhena RO, Cobre AF, Tonin FS, Pontarolo R. Systematic review with meta-analysis of the accuracy of diagnostic tests for COVID-19. Am J Infect Control 2021; 49: 21-29.
54. Kim M, Kweon S, Lee J, Baek S, Jeon B, Yoo H, et al. Weekly report on the COVID-19 situation in the Republic of Korea (As of March 28, 2020). Public Health Weekly Report 2020; 13: 792-806.
55. Xie JW, He Y, Zheng YW, Wang M, Lin Y, Lin L-R. Diagnostic accuracy of rapid antigen test for SARS-CoV-2: A systematic review and meta-analysis of 166,943 suspected COVID-19 patients. Microbiol Res 2022; 265: 127185.
56. Vilca-Alosilla JJ, Candia-Puma MA, Coronel-Monje K, Goyzueta-Mamani LD, Galdino AS, Machado-de-Ávila RA, et al. A systematic review and meta-analysis comparing the diagnostic accuracy tests of COVID-19. Diagnostics (Basel) 2023; 13: 1549.
| Files | ||
| Issue | Vol 17 No 5 (2025) | |
| Section | Review Article(s) | |
| DOI | https://doi.org/10.18502/ijm.v17i5.19875 | |
| Keywords | ||
| SARS-CoV-2 Diagnostic tests Sensitivity Specificity Meta-analysis | ||
| Rights and permissions | |
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This work is licensed under a Creative Commons Attribution-NonCommercial 4.0 International License. |
How to Cite
1.
Kadivarian S, Mosayeb M, Kooti S, Dashtbin S, Hosseinabadi S, Abiri R, Alvand A. Diagnostic value comparative analysis of the commercial kits for the detection of SARS-CoV-2 in clinical samples: a systematic review and meta-analysis. Iran J Microbiol. 2025;17(5):669-681.
