RealStar SARS-CoV-2 RT-PCR Kit
Manufactured by Altona Diagnostics, Germany - altona-diagnostics.com
Device identification number
22
HSC common list (RAT)
× No
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Comments
Instructions for Use at: https://altona-diagnostics.com/files/public/Content%20Homepage/-%2002%20RealStar/MAN%20-%20CE%20-%20EN/RealStar%20SARS-CoV-2%20RT-PCR%20Kit%201.0_WEB_CE_EN-S03.pdf
Assay Type
Nucleic acid-PCR
LOD
1.00E-01 PFU/ml for both targets, the S gene and the E gene
Positive control
Positive Control contains both targets, B-?CoV and SARS-CoV-2. Internal control.
Negative control
Negative control, not specified
Analytical Sensitivity
Expressed as LoD
Analytical Specificity
Ensured by the thorough selection of the oligonucleotides checked by sequence comparison analysis against publicly available sequences (B-?CoV, target E gene; SARSCoV-2, target S gene).
Notes
https://altona-diagnostics.com/en/products/reagents-140/reagents/realstar-real-time-pcr-reagents/realstar-sars-cov-2-rt-pcr-kit.html
Related Scientific Literature
An alternative workflow for molecular detection of SARS-CoV-2 - escape from the NA extraction kit-shortage, Copenhagen, Denmark, March 2020 Optimization of SARS-CoV-2 detection by RT-QPCR without RNA extraction Comparison of commercial RT-PCR diagnostic kits for COVID-19 Diagnostic performance of COVID-19 serology assays COVID-19 Special Column: Principles Behind the Technology for Detecting SARS-CoV-2, the Cause of COVID-19 Monitoring antibody response following SARS-CoV-2 infection: Diagnostic efficiency of four automated immunoassays Diagnostic techniques for COVID-19 and new developments COVID 19 diagnostic multiplicity and its role in community surveillance and control Current and Perspective Diagnostic Techniques for COVID-19 Real-time PCR-based SARS-CoV-2 detection in Canadian laboratories SARS-CoV-2 detection by direct rRT-PCR without RNA extraction Molecular and Immunological Diagnostic Tests of COVID-19: Current Status and Challenges SARS-CoV-2 antibody characterization in emergency department, hospitalized and convalescent patients by two semi-quantitative immunoassays Multicentre comparison of quantitative PCR-based assays to detect SARS-CoV-2, Germany, March 2020 Clinically practiced and commercially viable nanobio engineered analytical methods for COVID-19 diagnosis Rapid quantification of SARS-CoV-2-neutralizing antibodies using propagation-defective vesicular stomatitis virus pseudotypes Molecular, serological, and biochemical diagnosis and monitoring of COVID-19: IFCC taskforce evaluation of the latest evidence Comparison of commercial realtime reverse transcription PCR assays for the detection of SARS-CoV-2 International external quality assessment for SARS-CoV-2 molecular detection and survey on clinical laboratory preparedness during the COVID-19 pandemic, April/May 2020 Evaluation of two automated and three rapid lateral flow immunoassays for the detection of anti-SARS-CoV-2 antibodies Overcoming the bottleneck to widespread testing: A rapid review of nucleic acid testing approaches for COVID-19 detection Multicenter evaluation of the NeuMoDx SARS-CoV-2 Test Laboratory management for SARS-CoV-2 detection: a user-friendly combination of the heat treatment approach and rt-Real-time PCR testing Evaluation of the RealStar® SARS-CoV-2 RT-PCR kit RUO performances and limit of detection Comparison of a laboratory-developed test targeting the envelope gene with three nucleic acid amplification tests for detection of SARS-CoV-2 Potential Rapid Diagnostics, Vaccine and Therapeutics for 2019 Novel Coronavirus (2019-nCoV): A Systematic Review. A simple method for detection of a novel coronavirus (SARS-CoV-2) using one-step RT-PCR followed by restriction fragment length polymorphism Assay Techniques and Test Development for COVID-19 Diagnosis. Rapid establishment of laboratory diagnostics for the novel coronavirus SARS-CoV-2 in Bavaria, Germany, February 2020 Meta-analysis of the clinical performance of commercial SARS-CoV-2 nucleic acid, antigen and antibody tests up to 22 August 2020 Multicenter comparison of the Cobas 6800 system with the RealStar RT-PCR kit for the detection of SARS-CoV-2 Rapid point-of-care testing for SARS-CoV-2 in a community screening setting shows low sensitivity Comparison of nine different commercially available molecular assays for detection of SARS-CoV-2 RNA.
The database contains publicly available In Vitro Diagnostic Medical Devices for COVID-19 and it is being updated periodically. Please note that additional performance (as retrieved from manufacturers web pages) is provided only for devices commercially available with CE-IVD mark. Acknowledgements
