IRON-qPCR™ RV Kit

IRON-qPCR™ RV Kit (QRV-1113) is an in vitro diagnostic reagent for the qualitative detection of respiratory viruses, including SARS-CoV-2, Influenza A/B, and RSV-A/B, in nasopharyngeal swab specimens using the IRON-qPCR™ System.

Product Description

The IRON-qPCR™ RV Kit (QRV-1113) is an in vitro diagnostic reagent designed for use with the IRON-qPCR™ System (A-2600) for the qualitative detection of SARS-CoV-2, Influenza A, Influenza B, RSV A, and RSV B in human nasopharyngeal swab specimens. The kit provides an automated workflow from nucleic acid extraction to multiplex Real-Time PCR and result interpretation after sample loading.

Clinical specimen evaluation has confirmed high diagnostic sensitivity and specificity for each target. Additionally, the main kit can be stored at 15–35°C, while the QRV PC/NC control set is stored separately at 2–8°C.

Features and Benefits

Simultaneous detection in a streamlined workflow
Qualitatively detects SARS-CoV-2, Influenza A, Influenza B, RSV A, and RSV B in one streamlined testing process.
Rapid automated workflow
The IRON-qPCR™ system automates key testing steps from nucleic acid extraction and PCR setup to amplification and result interpretation, supporting timely and efficient testing.
Results in around 40 minutes
After cartridge preparation and sample loading, the test runs automatically, helping reduce hands-on time and simplify laboratory workflow.
Validated for human nasopharyngeal swab specimens
Performance has been verified with human nasopharyngeal swab specimens, supporting reliable respiratory virus testing.
Convenient storage and shipment
The kit supports room temperature handling, storage, and distribution for improved operational convenience.

Specifications

Specimen Type	Nasopharyngeal swab
Kit Contents	Test Cartridge(20 tests/kit), User Guide
Instrumentation	IRON-qPCR™ (A-2600)
Controls	IRON-qPCR™ RV Kit Control Set (QRV-1113C), provided separately
Tests/kit	20

Performances

Negative control and positive control are used to verify assay validity according to laboratory quality control procedures.

Representative test results of IRON-qPCR™ RV Kit. The assay includes internal process control signals to support result validity assessment for each sample.

The IRON-qPCR™ software automatically analyzes amplification data and reports qualitative results based on predefined interpretation criteria.

Clinical performance of the IRON-qPCR™ RV Kit was evaluated using residual nasopharyngeal swab specimens collected at a clinical site in France.
Diagnostic sensitivity and specificity were determined by comparison with CE-IVD marked comparator assays.

Clinical Evaluation Results