QIAstat-Dx Respiratory SARS-CoV-2 Panel - Canada

For multiplex syndromic testing applications

Products

The QIAstat-Dx Analyzer and QIAstat-Dx Respiratory SARS-CoV-2 Panel are intended for in vitro diagnostic use.

QIAstat-Dx Analyzer 1.0

Cat. No. / ID: 9002824

Instrument consists of both the Operational Module and Analytical Module.

QIAstat-Dx Respiratory SARS-CoV-2 Panel

Cat. No. / ID: 691223

6 individually packaged cartridges containing all reagents needed for sample preparation and multiplex RT-real time PCR plus internal control, including 6 transfer pipettes

QIAstat-Dx Operational Module

Cat. No. / ID: 9002813

Module enables interaction with the QIAstat-Dx Analyzer 1.0.

QIAstat-Dx Analytical Module

Cat. No. / ID: 9002814

Module contains the hardware and software for sample testing and analysis

Features

Enables detection of the SARS-CoV-2 virus that causes COVID-19, in addition to 20 other respiratory targets
Intuitive workflow with less than one-minute hands-on time
All wet and dry reagents onboard and room temperature stable
Comprehensive qualitative results available in about an hour

Product Details

To support the efforts for acessible testing to meet the demands of the COVID-19 outbreak, QIAGEN developed the QIAstat-Dx Respiratory SARS-CoV-2 Panel. This version of our multiplex syndromic cartridge detects and differentiates* 21 respiratory targets, including SARS-CoV-2 from nasopharyngeal swabs (NPS) eluted in universal transport media (UTM).

The QIAstat-Dx Analyzer, combined with QIAstat-Dx Respiratory SARS-CoV-2 assay cartridges, uses real-time PCR to detect pathogen nucleic acids in human biological samples. The QIAstat-Dx Analyzer and cartridges are designed as a closed system that contains on board all necessary reagents, enabling hands-off sample preparation. Detected real-time amplification signals are interpreted by the integrated software and are reported via an intuitive user interface.

* Enterovirus and Rhinovirus are both detected, but not differentiated, with the QIAstat-Dx Respiratory SARS-CoV-2 Panel.

Performance

The Limit of Detection (LOD) value obtained for the SARS-CoV-2 target tested with the QIAstat-Dx Respiratory SARS-CoV-2 Panel.

Pathogen	Strain	Source	Concentration	Detection rate
SARS-CoV-2	Clinical Sample	Hospital from Barcelona, Spain	500 copies/mL	20/20

The performance of SARS-CoV-2 target in the QIAstat-Dx Respiratory SARS-CoV-2 Panel was evaluated using retrospective nasopharyngeal swab clinical specimens in transport medium.

Sample	Sample type	N	% positive	(95% Cl)	% Negative	(95%Cl)
			SARS-CoV-2 Targets
Positives	Positive clinical sample	10	(10/10) 100%	N/A	0/0	N/A
	Low positive contrived sample (1x–2x LOD)	20	(20/20) 100%	N/A	0/0	N/A
	Total Positive Samples	30	(30/30) 100%	85.8–100%	0/0	N/A
Negative	Total Negative Samples	30	0/0	N/A	(30/30) 100%	85.8–100%

Principle

QIAstat-Dx Respiratory SARS-CoV-2 Panel Intended Use

The QIAstat-Dx Respiratory SARS-CoV-2 Panel is a multiplexed nucleic acid real-time PCR test intended for the qualitative detection and differentiation of nucleic acid from multiple respiratory viral and bacterial organisms, including the SARS-CoV-2 virus, in nasopharyngeal swabs (NPS) eluted in universal transport media collected from patients suspected of COVID‑19 by their healthcare provider.

The QIAstat-Dx Respiratory SARS-CoV-2 Panel is intended for the detection and differentiation of nucleic acid from SARS-CoV-2 and the following organism types and subtypes: Adenovirus, Coronavirus 229E, Coronavirus HKU1, Coronavirus NL63, Coronavirus OC43, SARS-CoV-2, Human Metapneumovirus A+B, Influenza A, Influenza A H1, Influenza A H3, Influenza A H1N1/pdm09, Influenza B, Parainfluenza virus 1, Parainfluenza virus 2, Parainfluenza virus 3, Parainfluenza virus 4, Rhinovirus/Enterovirus, Respiratory Syncytial Virus A+B, Bordetella pertussis, Chlamydophila pneumoniae, and Mycoplasma pneumoniae.

SARS-CoV-2 RNA and nucleic acids from the other respiratory viral and bacterial organisms identified by this test are generally detectable in nasopharyngeal swabs (NPS) during the acute phase of infection. Positive results are indicative of the presence of the identified microorganism, but do not rule out co-infection with other pathogens not detected by the test, or lower respiratory tract infection that is not detected by a nasopharyngeal swab. The agent detected may not be the definite cause of disease.

For SARS-CoV-2 positive specimens; clinical correlation with patient history and other diagnostic information is necessary to determine patient infection status. Laboratories are required to report all SARS-CoV-2 positive results to the appropriate public health authorities.

Negative results do not preclude SARS-CoV-2 infection and should not be used as the sole basis for treatment or other patient management decisions. Negative SARS-CoV-2 results must be combined with clinical observations, patient history, and epidemiological information. Negative results for other organisms identified by the test may require additional laboratory testing (eg, bacterial and viral culture, immunofluorescence and radiography) when evaluating a patient with possible respiratory tract infection.

Testing with the QIAstat-Dx Respiratory SARS-CoV-2 Panel is intended for use by qualified and trained operators who are proficient in performing the tests using the QIAstat-Dx Analyzer System.