For in vitro diagnostic use. Others cobas SARS-CoV-2 and Influenza A B v2 Test 5800-6800-8800 IVD cobas® SARS-CoV-2 & Influenza A/B v2 PID00000617 Qualitative nucleic acid test for use on the cobas® 5800/6800/8800 systems 10 033 401 190 10033401190 KIT COBAS 58/68/8800 SARSCOV2FLUV2 192T KIT COBAS 58/68/8800 SARSCOV2FLUV2 192T 00875197007213 Reagents, kits 1 kit 192 tests true cobas® SARS-CoV-2 & Influenza A/B v2 assay for use on the cobas® 5800/6800/8800 systems (cobas® SARS-CoV-2 & Influenza A/B v2) is an automated multiplex real-time RT-PCR assay intended for simultaneous qualitative detection and differentiation of SARS-CoV-2, influenza A virus, and/or influenza B virus RNA in healthcare provider-collected nasal and nasopharyngeal swab specimens, and self-collected nasal swab specimens (collected in a healthcare setting with instruction by a healthcare provider) from individuals suspected of respiratory viral infection consistent with COVID-19 by their healthcare provider. cobas® SARS-CoV-2 & Influenza A/B v2 is intended for use as an aid in the differential diagnosis of SARS-CoV-2, influenza A, and influenza B in humans and is not intended to detect influenza C. RNA from SARS-CoV-2, influenza A, and influenza B is generally detectable in respiratory specimens during the acute phase of infection. Positive results are indicative of the presence of SARS-CoV-2, influenza A, and/or influenza B RNA; clinical correlation with patient history and other diagnostic information is necessary to determine patient infection status. Positive results do not rule out bacterial infection or co-infection with other viruses. The agent detected may not be the definite cause of disease. Negative results do not preclude infection from SARS-CoV-2, influenza A, and/or influenza B and should not be used as the sole basis for treatment or other patient management decisions. Negative results must be combined with clinical observations, patient history, and epidemiological information. cobas® SARS-CoV-2 & Influenza A/B v2 is intended for use by qualified clinical laboratory personnel specifically instructed and trained in the techniques of real-time PCR and on the use of the cobas® 5800/6800/8800 systems. en cobas® SARS-CoV-2 & Influenza A/B v2 assay for use on the cobas® 6800/8800 Systems (cobas® SARS-CoV-2 & Influenza A/B v2) is an automated multiplex real-time RT-PCR assay intended for simultaneous qualitative detection and differentiation of SARS-CoV-2, influenza A virus, and influenza B virus RNA in healthcare provider-collected nasal and nasopharyngeal swab specimens, and self-collected anterior nasal swab specimens (collected in a healthcare setting with instruction by a healthcare provider) from individuals suspected of respiratory viral infection consistent with COVID- 19 by their healthcare provider. cobas® SARS-CoV-2 & Influenza A/B v2 is intended for use as an aid in the differential diagnosis of SARS-CoV-2, influenza A, and influenza B in humans and is not intended to detect influenza C. Testing is limited to laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, that meet requirements to perform moderate or high complexity tests. RNA from SARS-CoV-2, influenza A, and influenza B is generally detectable in respiratory specimens during the acute phase of infection. Positive results are indicative of the presence of SARS-CoV-2, influenza A, and/or influenza B RNA; clinical correlation with patient history and other diagnostic information is necessary to determine patient infection status. Positive results do not rule out bacterial infection or co-infection with other viruses. The agent detected may not be the definite cause of disease. Testing facilities within the United States and its territories are required to report all SARS-CoV-2 results to the appropriate public health authorities. Negative results do not preclude infection from SARS-CoV-2, influenza A, and/or influenza B and should not be used as the sole basis for treatment or other patient management decisions. Negative results must be combined with clinical observations, patient history, and epidemiological information. cobas® SARS-CoV-2 & Influenza A/B v2 is intended for use by qualified clinical laboratory personnel specifically instructed and trained in the techniques of real-time RT-PCR and on the use of the cobas® 6800/8800 Systems. In the US, cobas® SARS- CoV-2 & Influenza A/B v2 is only for use under the Food and Drug Administration’s Emergency Use Authorization. en cobas® SARS-CoV-2 & Influenza A/B v2 is based on fully automated sample preparation (nucleic acid extraction and purification) followed by PCR amplification and detection. The cobas® 5800 system is designed as one integrated instrument. The cobas® 6800/8800 systems consist of the sample supply module, the transfer module, the processing module, and the analytic module. Automated data management is performed by the cobas® 5800 system or cobas® 6800/8800 systems software, which assigns results for all tests. Results can be reviewed directly on the system screen, and printed as a report. Nucleic acid from patient samples and added internal control RNA (RNA IC) molecules are simultaneously extracted. Nucleic acid is released by addition of proteinase and lysis reagent to the sample. The released nucleic acid binds to the silica surface of the added magnetic glass particles. Unbound substances and impurities, such as denatured protein, cellular debris and potential PCR inhibitors, are removed with subsequent wash steps and purified nucleic acid is eluted from the magnetic glass particles with elution buffer at elevated temperature. External controls (positive and negative) are processed in the same way. Selective amplification of SARS-CoV-2 target nucleic acid from the sample is achieved by the use of target-specific forward and reverse primers for ORF1a/b non-structural region that is unique to SARS-CoV-2. Additionally, a conserved region in the structural protein envelope E-gene was chosen for pan-Sarbecovirus detection. The pan- Sarbecovirus detection set will also detect SARS-CoV-2 virus. For influenza A, selective amplification of target nucleic acid from the sample is achieved by the use of two target-specific sets of forward and reverse primers: one for the genomic region ecoding matrix proteins 1 and 2 (M1/M2) and one for the gene encoding polymerase basic protein 2 (PB2). For influenza B, selective amplification of target nucleic acid from the sample is achieved by the use of target-specific forward and reverse primers for the nuclear export protein (NEP) / nonstructural protein 1(NS1) genomic region. Selective amplification of RNA Internal Control is achieved by the use of non-competitive sequence specific forward and reverse primers which have no homology with the coronavirus or influenza genomes. Amplified target is detected by cleavage of fluorescently labeled oligonucleotide probe. A thermostable DNA polymerase enzyme is used for amplification. The cobas® SARS-CoV-2 & Influenza A/B v2 master mix contains detection probes which are specific for the coronavirus type SARS-CoV-2, members of the Sarbecovirus subgenus, influenza A virus, influenza B virus and the RNA Internal Control nucleic acid. The coronavirus, influenza A, influenza B and RNA Internal Control detection probes are each labeled with unique fluorescent dyes that act as a reporter. Each probe also has a second dye which acts as a quencher. When not bound to the target sequence, the fluorescent signals of the intact probes are suppressed by the quencher dye. During the PCR amplification step, hybridization of the probes to the specific single -stranded DNA template results in cleavage of the probe by the 5' to 3' exonuclease activity of the DNA polymerase resulting in separation of the reporter and quencher dyes and the generation of a fluorescent signal. With each PCR cycle, increasing amounts of cleaved probes are generated and the cumulative signal of the reporter dye increases concomitantly. Each reporter dye is measured at defined wavelengths, which enables simultaneous detection and discrimination of the amplified coronavirus targets, influenza targets and the RNA Internal Control. The master mix includes deoxyuridine triphosphate (dUTP), instead of deoxythimidine triphosphate (dTTP), which is incorporated into the newly synthesized DNA (amplicon). Any contaminating amplicons from previous PCR runs are destroyed by the AmpErase enzyme [uracil-N-glycosylase], which is included in the PCR mix, when heated in the first therma l cycling step. However, newly formed amplicons are not destroyed since the AmpErase enzyme is inactivated once exposed to temperatures above 55°C. en cobas® SARS-CoV-2 & Influenza A/B v2 is based on fully automated sample preparation (nucleic acid extraction and purification) followed by PCR amplification and detection. The cobas® 6800/8800 Systems consist of the sample supply module, the transfer module, the processing module, and the analytic module. Automated data management is performed by the cobas® 6800/8800 software, which assigns results for all tests. Results can be reviewed directly on the system screen, and printed as a report. Nucleic acid from patient samples and added internal control RNA (RNA IC) molecules are simultaneously extracted. Nucleic acid is released by addition of proteinase and lysis reagent to the sample. The released nucleic acid binds to the silica surface of the added magnetic glass particles. Unbound substances and impurities, such as denatured protein, cellular debris and potential PCR inhibitors, are removed with subsequent wash steps and purified nucleic acid is eluted from the magnetic glass particles with elution buffer at elevated temperature. External controls (positive and negative) are processed in the same way with each cobas® SARS-CoV-2 & Influenza A/B v2 run. Selective amplification of SARS-CoV-2 target nucleic acid from the sample is achieved by the use of target-specific forward and reverse primers for ORF1a/b non-structural region that is unique to SARS-CoV-2. Additionally, a conserved region in the structural protein envelope E-gene was chosen for pan-Sarbecovirus detection. The pan- Sarbecovirus detection set will also detect SARS-CoV-2 virus. For influenza A, selective amplification of target nucleic acid from the sample is achieved by the use of two target-specific sets of forward and reverse primers: one for the genomic region encoding matrix proteins 1 and 2 (M1/M2) and one for the gene encoding polymerase basic protein 2 (PB2). For influenza B, selective amplification of target nucleic acid from the sample is achieved by the use of target-specific forward and reverse primers for the nuclear export protein (NEP) / nonstructural protein 1 (NS1) genomic region. Selective amplification of RNA Internal Control is achieved by the use of non-competitive sequence specific forward and reverse primers which have no homology with the coronavirus or influenza genomes. Amplified target is detected by cleavage of fluorescently labeled oligonucleotide probe. A thermostable DNA polymerase enzyme is used for amplification. The cobas® SARS-CoV-2 & Influenza A/B v2 master mix contains detection probes which are specific for the coronavirus type SARS-CoV-2, members of the Sarbecovirus subgenus, influenza A virus, influenza B virus and the RNA Internal Control nucleic acid. The coronavirus, influenza A, influenza B and RNA Internal Control detection probes are each labeled with unique fluorescent dyes that act as a reporter. Each probe also has a second dye which acts as a quencher. When not bound to the target sequence, the fluorescent signals of the intact probes are suppressed by the quencher dye. During the PCR amplification step, hybridization of the probes to the specific single-stranded DNA template results in cleavage of the probe by the 5' to 3' exonuclease activity of the DNA polymerase resulting in separation of the reporter and quencher dyes and the generation of a fluorescent signal. With each PCR cycle, increasing amounts of cleaved probes are generated and the cumulative signal of the reporter dye increases concomitantly. Each reporter dye is measured at defined wavelengths, which enables simultaneous detection and discrimination of the amplified coronavirus targets, influenza targets and the RNA Internal Control. The master mix includes deoxyuridine triphosphate (dUTP), instead of deoxythimidine triphosphate (dTTP), which is incorporated into the newly synthesized DNA (amplicon). Any contaminating amplicons from previous PCR runs are destroyed by the AmpErase enzyme [uracil-N-glycosylase], which is included in the PCR mix, when heated in the first thermal cycling step. However, newly formed amplicons are not destroyed since the AmpErase enzyme is inactivated once exposed to temperatures above 55°C. en

cobas^® SARS-CoV-2 & Influenza A/B v2

Test qualitativo dell'acido nucleico da utilizzare sui sistemi cobas^® 5800/6800/8800

IVD

Contattaci

Diagnosi differenziale affidabile ad alta produttività per COVID-19 e influenza

I sintomi del COVID-19 e dell’influenza possono sembrare simili¹. Fornire l’accesso a test affidabili ed efficienti sui sistemi cobas® 5800/6800/8800 completamente automatizzati può aiutare a orientare le decisioni terapeutiche e a prevenire l’ulteriore trasmissione della malattia.

Sia le infezioni da SARS-CoV-2 che quelle da influenza possono presentare sintomi simili, ma è probabile che le indicazioni terapeutiche siano diverse¹. Sapere quale infezione ha un paziente consentirà al medico di orientare in modo ottimale il triage e le decisioni terapeutiche, e infondere sicurezza ai pazienti.

Il test cobas® SARS-CoV-2 & Influenza A/B è un test multiplex PCR a trascrizione inversa (RT-PCR) destinato al rilevamento qualitativo simultaneo e alla differenziazione del SARS-CoV-2, del virus dell’influenza A e/o del virus dell’influenza B nei campioni rilevati con tamponi nasali o nasofaringei da soggetti con sospetta infezione virale respiratoria coerente con COVID-19 in base al parere del loro fornitore di assistenza sanitaria.

Diagnosi dei pazienti sintomatici

Fornire una diagnosi accurata di infezione da SARS-CoV-2 o influenza A/B per una corretta gestione dei pazienti.

Per soggetti a rischio o con sospetta infezone

Offrire test affidabili e accessibili per ridurre l’ulteriore diffusione del virus dopo stretto contatto con individui infetti.

Supportare test ad alto volume

Utilizzare i sistemi cobas® 5800/6800/8800 ad alto volume e un ampio menu per ampliare le soluzioni di test per COVID-19.

Uso previsto¹

Il test cobas® SARS-CoV-2 & Influenza A/B per l’uso sui sistemi cobas® 5800/6800/8800 è un test automatico RT-PCR real-time multiplex destinato al rilevamento qualitativo rapido e alla differenziazione simultanea dell’RNA di SARS-CoV-2, virus dell’influenza A e influenza B in campioni di analisi da tamponi nasofaringei e nasali acquisiti dal fornitore di assistenza sanitaria e in campioni di analisi da tamponi nasofaringei e nasali acquisiti autonomamente (acquisiti in un contesto sanitario con istruzioni da parte di un operatore sanitario) da soggetti con sospetta infezione virale respiratoria coerente con COVID-19 in base al parere del fornitore di assistenza sanitaria. Il test cobas® SARS-CoV-2 & Influenza A/B è destinato all’uso come ausilio nella diagnosi differenziale di SARS-CoV-2, influenza A e influenza B negli esseri umani e non è destinato a rilevare l’influenza C.

L’RNA di SARS-CoV-2, influenza A e influenza B è generalmente rilevabile nei campioni respiratori durante la fase acuta dell’infezione. I risultati positivi sono indicativi della presenza di RNA di SARS-CoV-2, influenza A, e/o influenza B; per determinare lo stato di infezione del paziente è necessaria una correlazione clinica con l’anamnesi del paziente e altre informazioni diagnostiche. I risultati positivi non escludono l’infezione batterica o la co-infezione con altri virus. L’agente rilevato potrebbe non essere la causa certa della malattia.

I risultati negativi non precludono l’infezione da SARS-CoV-2, influenza A e/o influenza B e non devono essere utilizzati come unica base per il trattamento o altre decisioni di gestione del paziente. I risultati negativi devono essere combinati con osservazioni cliniche, anamnesi del paziente e informazioni epidemiologiche.

Il test cobas® SARS-CoV-2 & Influenza A/B è destinato all’uso da parte di personale di laboratorio clinico qualificato specificamente istruito e addestrato sulle tecniche di PCR real-time e sull’uso dei sistemi cobas® 5800/6800/8800.

Contattaci

Prestazioni del test

Visualizza tabella completa

TARGET	CONFORMITÀ POSITIVA	CONFORMITÀ NEGATIVA	LoD (95% probit)^c
SARS-CoV-2*	96,4%^a	98,0%^a	0,0063 TCID₅₀/mL (SARS-CoV-2)^b 0,0082 TCID₅₀/mL (pan-Sarbecovirus)^b
Influenza A**	100%	99,6%	0,086 TCID₅₀/mL
Influenza B**	100%	99,7%	0,026 TCID₅₀/mL

* Rispetto all’EUA approvata dalla FDA, cobas^® SARS-CoV-2 sui sistemi cobas^®6800/8800

** Rispetto a un test di PCR con trascrittasi inversa (RT-PCR) real-time approvato dalla FDA

^a Risultati discordanti per SARS-CoV-2 provengono da campioni di pazienti in fase di guarigione/convalescenti con carica virale decrescente prossima o inferiore al LOD di entrambi i test

^b Un TCID₅₀/mL è pari a 7.393 genomi equivalenti mediante ddPCR (secondo il Certificato di analisi del fornitore, USA-WA1/2020, coltura infettiva, N. di cat. NR-52281, Lotto 70033175)

^cIn base alla prestazioni combinate del lotto co-formulate

Parametri chiave

Visualizza tabella completa

PARAMETRO	PRESTAZIONI
Target	SARS-CoV-2, pan-Sarbecovirus, influenza A, influenza B
Tipo di campione	Campioni di tampone nasofaringeo collettati in Copan UTM-RT System o in BD UVT System Campioni di tamponi nasali acquisiti in Copan UTM-RT SystemT, in BD UVT System, in cobas® PCR media e in soluzione fisiologica allo 0,9%
Quantità minima di campione richiesta	0,6 µL
Volume di pipettamento del campione	0,4 µL
Durata test	I risultati sono disponibili entro meno di 3,5 ore dal caricamento del campione sul sistema
Software di sistema	Si esegue con le versioni del software 1.2, 1.3 e 1.4
Dimensioni e stabilità dopo l'apertura	384 test; 90 giorni con 40 riutilizzi

Riferimenti bibliografici:

https://www.hopkinsmedicine.org/health/conditions-and-diseases/coronavirus/coronavirus-disease-2019-vs-the-flu.
Foglio illustrativo cobas® SARS-CoV-2 & Influenza A/B, 10017236001-02IT, V 2 del 14/03/2025

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cobas^® SARS-CoV-2 & Influenza A/B v2