RealStar SARS-CoV-2 RT-PCR Kit
Manufactured by Altona Diagnostics, Germany -
Device identification number
HSC common list (RAT)
2022-08-24 09:08:01 CET
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
1.00E-01 PFU/ml for both targets, the S gene and the E gene
Positive Control contains both targets, B-?CoV and SARS-CoV-2. Internal control.
Negative control, not specified
Expressed as LoD
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).
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.