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Verification and diagnostic evaluation of the RealStar® Middle East respiratory syndrome coronavirus (N gene) reverse transcription-PCR kit 1.0.
Future Microbiol. 2019 07; 14:941-948.FM

Abstract

Aim:

We report the diagnostic evaluation of a confirmatory reverse transcription-PCR (RT-PCR) kit targeting the Middle East respiratory syndrome coronavirus (MERS-CoV) N gene. Material & methods: 33 patient samples from two collections sites in Riyadh, Saudi Arabia, which were pre-characterized via real-time RT-PCR targeting MERS-CoV orf1a and upE, and were tested using the MERS-CoV N gene, as a confirmatory assay. This diagnostic procedure follows a two-step diagnostics scheme, recommended by the WHO.

Results:

18/33 samples tested positive, 11/33 tested negative for MERS-CoV RNA and 2/33 showed uncertain results.

Conclusion:

The results suggest, that the RealStar® MERS-CoV (N gene) RT-PCR kit 1.0 can be considered a suitable and reliable confirmatory assay in combination with the RealStar MERS-CoV RT-PCR kit 1.0 according to the diagnostic scheme recommended by WHO.

Authors+Show Affiliations

aItona Diagnostics GmbH, Hamburg, Germany.aItona Diagnostics GmbH, Hamburg, Germany.aItona Diagnostics GmbH, Hamburg, Germany.aItona Diagnostics GmbH, Hamburg, Germany.aItona Diagnostics GmbH, Hamburg, Germany.Ministry of Health, Riyadh Regional Laboratory, Riyadh, Saudi Arabia.Ministry of Health, Riyadh Regional Laboratory, Riyadh, Saudi Arabia.Ministry of Health, Riyadh Regional Laboratory, Riyadh, Saudi Arabia.King Fahad Medical City, Riyadh, Saudi Arabia.Ministry of Health, Riyadh Regional Laboratory, Riyadh, Saudi Arabia.King Fahad Medical City, Riyadh, Saudi Arabia.

Pub Type(s)

Journal Article
Validation Study

Language

eng

PubMed ID

31271059

Citation

Hecht, Leonie-Sophie, et al. "Verification and Diagnostic Evaluation of the RealStar® Middle East Respiratory Syndrome Coronavirus (N Gene) Reverse transcription-PCR Kit 1.0." Future Microbiology, vol. 14, 2019, pp. 941-948.
Hecht LS, Jurado-Jimenez A, Hess M, et al. Verification and diagnostic evaluation of the RealStar® Middle East respiratory syndrome coronavirus (N gene) reverse transcription-PCR kit 1.0. Future Microbiol. 2019;14:941-948.
Hecht, L. S., Jurado-Jimenez, A., Hess, M., Halas, H. E., Bochenek, G., Mohammed, H., Alzahrani, F., Asiri, M. O., Hasan, R., Alamri, A., & Alotaibi, S. (2019). Verification and diagnostic evaluation of the RealStar® Middle East respiratory syndrome coronavirus (N gene) reverse transcription-PCR kit 1.0. Future Microbiology, 14, 941-948. https://doi.org/10.2217/fmb-2019-0067
Hecht LS, et al. Verification and Diagnostic Evaluation of the RealStar® Middle East Respiratory Syndrome Coronavirus (N Gene) Reverse transcription-PCR Kit 1.0. Future Microbiol. 2019;14:941-948. PubMed PMID: 31271059.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Verification and diagnostic evaluation of the RealStar® Middle East respiratory syndrome coronavirus (N gene) reverse transcription-PCR kit 1.0. AU - Hecht,Leonie-Sophie, AU - Jurado-Jimenez,Angeles, AU - Hess,Markus, AU - Halas,Hussein El, AU - Bochenek,Gregor, AU - Mohammed,Hala, AU - Alzahrani,Fahd, AU - Asiri,Mohammed O, AU - Hasan,Rami, AU - Alamri,Aref, AU - Alotaibi,Sultan, Y1 - 2019/07/04/ PY - 2019/7/5/pubmed PY - 2020/2/6/medline PY - 2019/7/5/entrez KW - MERS-CoV KW - WHO diagnostic scheme KW - diagnostics KW - emerging diseases KW - molecular diagnostics KW - preparedness KW - real-time RT-PCR SP - 941 EP - 948 JF - Future microbiology JO - Future Microbiol VL - 14 N2 - Aim: We report the diagnostic evaluation of a confirmatory reverse transcription-PCR (RT-PCR) kit targeting the Middle East respiratory syndrome coronavirus (MERS-CoV) N gene. Material & methods: 33 patient samples from two collections sites in Riyadh, Saudi Arabia, which were pre-characterized via real-time RT-PCR targeting MERS-CoV orf1a and upE, and were tested using the MERS-CoV N gene, as a confirmatory assay. This diagnostic procedure follows a two-step diagnostics scheme, recommended by the WHO. Results: 18/33 samples tested positive, 11/33 tested negative for MERS-CoV RNA and 2/33 showed uncertain results. Conclusion: The results suggest, that the RealStar® MERS-CoV (N gene) RT-PCR kit 1.0 can be considered a suitable and reliable confirmatory assay in combination with the RealStar MERS-CoV RT-PCR kit 1.0 according to the diagnostic scheme recommended by WHO. SN - 1746-0921 UR - https://www.unboundmedicine.com/medline/citation/31271059/Verification_and_diagnostic_evaluation_of_the_RealStar®_Middle_East_respiratory_syndrome_coronavirus__N_gene__reverse_transcription_PCR_kit_1_0_ DB - PRIME DP - Unbound Medicine ER -