MRSA/SA Test

Dénomination commerciale

MRSA/SA Test

D-MARSA-10NU

B-MARSA-10NU

Numéro de référence/catalogue

MARSA-10

EUDAMED

IVDD — Général

Législation applicable

IVDD [Directive 98/79/CE relative aux dispositifs médicaux de diagnostic in vitro]

Statut

Sur le marché

Quantité

1

Description complémentaire du produit

The MRSA/SA Test is a rapid nucleic acid sSPRT-RT-qPCR test intended for in vitro qualitative detection of Staphylococcus aureus (SA) and methicillin-resistant Staphylococcus aureus (MRSA) in nasopharyngeal swab, nasal swab or throat swab from individuals with suspected MRSA/SA infections. The test runs compatible with FlashDx-1000-E, FlashDx sSPRT, or other validated FlashDx systems. The product realization process complies with IVDD 98/79 EC Directive Annex III conformity assessment procedure, with Riomavix S.L. acting as the EU authorised representative (SRN: ES-AR-000001202).

URL des informations complémentaires

Aucune URL d'informations complémentaires renseignée par le fabricant.

Dimensions cliniques

Aucune dimension clinique enregistrée pour ce dispositif.

Nomenclature européenne des dispositifs médicaux — la classification produit UE attribuée à ce dispositif.

• W0105030704HTLV MULTIPLE - NA REAGENTS

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• This test is for in vitro diagnostic use only. All testing samples shall be handled as a potential source of infection, and all operations must be performed in a microbiological and biomedical laboratory equipped with full biosafety protection devices and standard operating protocols to protect laboratory personnel from infection. Operators must strictly comply with the specified sample types, collection, transport and handling procedures stated in the instructions for use; failure to follow the guidance will compromise test accuracy and performance. Sequence variation of bacterial nucleic acid targets carries a risk of false negative results; even conserved SA gene targets may present false negative outcomes due to gene mutation. Improper specimen collection, transportation, storage, experimental operation or unsuitable testing environment may produce false positive or false negative test results. Specimens collected after administration of live attenuated vaccines may lead to false positive signals. Unverified interfering substances and uncharacterized PCR inhibitors in clinical samples can cause false negative outcomes. Insufficient sample volume may generate invalid test results. Nucleic acid fragments may persist in the human body for an extended period, and a positive test result does not confirm active viable bacterial infection or clinical symptomatic disease caused by Staphylococcus aureus. Test positive and negative predictive values are highly dependent on pathogen prevalence within the tested population, and assay performance may vary across different patient cohorts. Test results must be interpreted comprehensively together with patient clinical manifestations, medical history and other auxiliary laboratory examination data and shall not be used as the sole basis for antibiotic therapy or patient clinical management decisions.

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