Standard M10
Der Standard M10 von SD Biosensor ist ein vollautomatisches Point-of-Care-PCR-System für die schnelle und präzise molekulare Diagnostik direkt am Patienten. Das kompakte, modulare System kombiniert isothermale Amplifikation mit Echtzeit-PCR und liefert Ergebnisse in Laborqualität innerhalb von 30 bis 80 Minuten. Damit eignet es sich ideal für Kliniken, Notaufnahmen, Intensivstationen und dezentrale Testzentren, die auf zuverlässige, schnelle und skalierbare PCR-Ergebnisse angewiesen sind.
Der Standard M10 ist eine modulare, skalierbare POC-MDx-Plattform mit bis zu acht unabhängig arbeitenden Modulen. Jede Einheit integriert die Nukleinsäureextraktion und Amplifikation in einer geschlossenen All-in-one-Kartusche. Ein 10,1-Zoll-Touchscreen mit animierter Benutzerführung ermöglicht eine einfache Bedienung und Echtzeitüberwachung. Das System ist mit HL7, LAW und LIS/HIS kompatibel und unterstützt so nahtlose Datenintegration in Krankenhausnetzwerke. Der Workflow folgt dem Prinzip „Sample-in – Result-out“, wodurch manuelle Zwischenschritte entfallen. Lyophilisierte Reagenzien ermöglichen Lagerung bei Raumtemperatur, und der Wartungsaufwand ist minimal.
Der Standard M10 deckt ein breites Spektrum klinisch relevanter Anwendungsfelder ab:
- Akutdiagnostik in Notaufnahmen und Intensivstationen (z. B. SARS-CoV-2, Influenza A/B, RSV)
- Mikrobiologische Routinediagnostik in Krankenhauslaboren (C. difficile, Mycobacterium tuberculosis)
- Infektionsdiagnostik in der Tropenmedizin (Dengue-, Zika-, Chikungunya-, West-Nil- und Gelbfiebervirus)
- Onkologische und gynäkologische Vorsorgeprogramme (HPV-High-Risk-Typen 16, 18, 31, 33, 45 u. a.)
- Dezentrale PCR-Testung in Arztpraxen und Pflegeeinrichtungen ohne eigenes Labor
In der klinischen Praxis bietet der Standard M10 eine zuverlässige Lösung für zeitkritische Diagnoseszenarien:
- Schnelle PCR-Diagnostik bei COVID-19-Verdacht mit paralleler Influenza-/RSV-Differenzierung
- Erkennung von Mycobacterium tuberculosis und Rifampicin-/Isoniazid-Resistenz bei MDR-TB
- HPV-Typisierung zur Erkennung onkogener Hochrisikostämme
- Nachweis von Clostridioides difficile in Stuhlproben bei Verdacht auf nosokomiale Infektionen
- Arbovirus-Panel für die gleichzeitige Identifikation von DENV, ZIKV, CHIKV, YFV und WNV
- Molekulare Differenzierung zwischen tuberkulösen und nicht-tuberkulösen Mykobakterien
- Vollautomatischer Workflow mit minimalem Bedienaufwand („Sample-in-Result-out“)
- Multiplex-Assays mit bis zu 12 Zielsequenzen pro Lauf
- Zuverlässige Ergebnisse durch Echtzeit-PCR und interne Kontrollen
- Deutlich reduziertes Kreuzkontaminationsrisiko durch geschlossene Kartuschentechnologie
- Kompakte, modulare Bauweise mit bis zu acht simultanen Analysen
- Raumtemperaturstabile Reagenzien für flexible Handhabung
- HL7/LIS/HIS-Kompatibilität für effiziente Einbindung in Kliniksysteme
- Geringer Energieverbrauch und minimale Wartungskosten
Im Vergleich zu anderen Point-of-Care-PCR-Systemen bietet der Standard M10 eine besonders modulare Architektur und hohe Testvielfalt. Während viele Konkurrenzsysteme auf festgelegte Assays beschränkt sind, ermöglicht das M10-System parallele und skalierbare Diagnostik für ein breites Erregerspektrum. Die Kombination aus isothermaler Amplifikation und Echtzeit-PCR sorgt für schnelle und gleichzeitig hochempfindliche Ergebnisse. Zudem erlaubt die All-in-one-Kartusche den Betrieb ohne Laborausstattung und reduziert Kontaminationsrisiken erheblich.
Parameterübersicht
Es ist möglich, dass bestimmte berechnete Parameter nicht angegeben sind.
Testübersicht (8)
Flu/RSV/SARS-CoV-2
SARS-CoV-2
C. difficile
MDR-TB
Erkennung von Mycobacterium tuberculosis und Resistenz gegen Rifampicin (RIF) und Isoniazid (INH).
MTB/NTM
Nachweis von Mycobacterium tuberculosis-Komplex (MTBC) und nicht-tuberkulösen Mykobakterien (NTM).
HPV
MPX/OPX
Arbovirus Panel
Simultaner Nachweis des Dengue-Virus aus 4 Serotypen, des Zika-Virus, des Chikungunya-Virus, des Gelbfiebervirus und des West-Nil-Virus.
Flu/RSV/SARS-CoV-2
SARS-CoV-2
C. difficile
Studien & Produktdokumente
Rapid RT-PCR identification of SARS-CoV-2 in screening donors of fecal microbiota transplantation.
KI-Zusammenfassung
Die vorliegenden Vergleichsstudien zeigen, dass das STANDARD M10 System in verschiedenen diagnostischen Bereichen eine hohe Leistungsfähigkeit aufweist, jedoch je nach Testpanel und Referenzsystem Unterschiede bestehen. In der respiratorischen Diagnostik (Influenza, RSV, SARS-CoV-2) belegen Studien (Jeong et al., Abdullah et al., Colagrossi et al.) eine hohe Sensitivität und Spezifität, die vergleichbar mit etablierten Systemen wie dem Cepheid Xpert Xpress ist, wenngleich Jensen et al. eine überlegene Performance des Xpert Xpress bei geringen Viruslasten feststellten. Im Bereich der Tuberkulose-Diagnostik (MTB/RIF/INH) zeigt das M10 eine hohe Genauigkeit und gilt als ebenbürtige Alternative zum Xpert MTB/RIF Ultra (Stephen et al., Luukinen et al.), wobei das spezielle NTM-Panel etwas schwächer abschnitt. Bei der Detektion von C. difficile (Suominen et al.) und Dengue-Viren (Scarpaleggia et al.) lieferte das Gerät ebenfalls zuverlässige Ergebnisse auf Augenhöhe mit Systemen von Roche (cobas Liat) oder Abbott. Kritisch angemerkt wurde eine geringere klinische Genauigkeit bei Mpox-Urinproben im Vergleich zum Xpert Mpox (Romero-Ramirez et al.). Insgesamt wird das M10 als effiziente Point-of-Care-Lösung bewertet, die Arbeitsabläufe in Kliniken und Praxen optimieren kann.
"In conclusion, our findings demonstrate that the updated M10 Fast assay reliably detects influenza A/B, RSV, and SARS-CoV-2 with high sensitivity and specificity, offering improved detection of low viral loads. Its enhanced performance and faster turnaround time support timely clinical decision-making and public health responses, particularly during periods of influenza, RSV, and SARS-CoV-2 cocirculation."
"The Xpert® Mpox had good diagnostic accuracy for both sample types while the M10 MPX/OPX clinical accuracy was deficient with URS. Our data supports the use of URS during the first 3 days of symptoms onset for mpox diagnosis."
"In conclusion, this study showed that commercially available RT2-PCR kits for the detection of DENV [RealStar Dengue PCR Kit 3.0, Clonit’ngo Zika, Dengue & Chikungunya, BioPerfectus Zika Virus/Dengue Virus/Chikungunya Virus Real Time PCR Kit, Novaplex Tropical fever virus, STANDARD M10 Arbovirus Panel] generally have high diagnostic accuracy and, therefore, their wider adoption is advisable. In the context of a lean laboratory, multiplex arboviral RT2-PCR panels were found to be accurate and may optimize workplaces and workflows. However, it should be acknowledged that DENV RT2-PCR assays cost more than other techniques like antigen tests, and most of them require sophisticated laboratory equipment and qualified personnel; this may hamper the adoption of RT2-PCR in resource-constrained settings. Setting-specific, cost-consequence and budget impact analyses within the health technology assessment (HTA) framework may be helpful."
"The STANDARD™ M10 MDR-TB assay demonstrated high diagnostic accuracy in the detection of MTB and RIF and INH resistance. This molecular assay can also be used as an alternative to other mWRD assays [Xpert MTB/RIF Ultra, MGIT culture, and phenotypic drug susceptibility testing]"
"This study demonstrates improved analytical and clinical performance of Xpert Xpress CoV-2/Flu/RSV plus compared to STANDARD M10 Flu/RSV/SARS-CoV-2, which is important for ensuring accuracy of diagnosis at all stages of a respiratory infection."
"In this clinical evaluation of the STANDARD M10 MDR-TB and MTB/NTM assays in a clinical setting of low TB incidence, the M10 MDR-TB assay demonstrated clinical performance equivalent to the established Xpert MTB/RIF Ultra assay. However, the M10 MTB/NTM assay performed slightly weaker in detecting MTB and missed one-third of all NTM cases, showing little potential for reliable screening of NTM. Both assays showed excellent performance with SSM-positive samples. While the M10 MDR-TB assay exhibited great potential in rapid detection of MTB and its RIF/INH resistance, its suitability for any clinical setting may be somewhat limited by biosafety concerns related to weak inactivation of MTB during sample pretreatment. Further clinical evaluation studies are needed to establish its status as a relevant competitor for the Xpert MTB/RIF Ultra assay."
"In conclusion, STANDARD M10 demonstrated high sensitivity and specificity for the detection of IAV, IBV, RSV, and SARS-CoV-2 virus from clinical respiratory samples. The diagnostic performance of STANDARD M10 is comparable to the established Xpert Xpress SARS-CoV-2 or Xpert Xpress Flu/RSV assays. With the capabilities for simultaneous detection of these four important respiratory viruses from a single sample within an hour, in addition to the fully automated system, STANDARD M10 can be used as a point-of-care test assay in an emergency or critical care department or facilities without sophisticated laboratory set-ups. This assay is particularly useful in tropical countries, like Malaysia, which have year-round endemic influenza and COVID-19."
"In conclusion, our results support the optimal diagnostic performance of the novel STANDARD™ M10 SARS-CoV-2 assay in a real-life ER setting, constituted by pediatric patients in comparison with adult patients. The remarkable degree of similarity in terms of reliability, sensitivity, and specificity, with our current diagnostic reference assay, supports the implementation of STANDARD™ M10 SARS-CoV-2 in a modern diagnostic approach to SARS-CoV-2 infection. On this basis, the availability of a molecular test, fast, easy, and reliable becomes of major importance in the management of patients that require a molecular test (i.e., emergency rooms, fragile patients, etc.), particularly if it is less expensive and therefore sustainable, considering also the decrease of the budget in many countries dedicated to the fight against COVID-19."
"We evaluated the analytical performance of three commercial molecular assays for rapid detection of Clostridioides difficile toxin B in stool samples. The results were compared with results from the BD MAX™ Cdiff assay. We analyzed forty negative and thirty-two positive stool samples with three rapid assays: Roche cobas® Liat® Cdiff, SD Biosensor STANDARD™ M10 C. difficile and Cepheid Xpert® C. difficile BT. The assays demonstrated a sensitivity of 96.9 %, 96.9 % and 100.0 % and a specificity of 100 %, 97.5 % and 97.5 %, respectively. There is limited data available on the analytical performance of the newly introduced STANDARD™ M10 C. difficile assay. In this study, all three rapid assays demonstrated similarly high analytical performance and can be used for detection of toxigenic C. difficile."
KI-Zusammenfassung
Die vorliegenden Laborevaluierungen zeigen, dass das STANDARD™ M10-System eine diagnostische Performance aufweist, die direkt mit etablierten laborbasierten RT-PCR-Methoden vergleichbar ist. In vergleichenden Studien mit Referenzsystemen wie dem Allplex™ STI Essential Assay, Seegene Anyplex™ II HPV HR, sowie verschiedenen Standard-Laborassays für respiratorische Erreger (SARS-CoV-2, Influenza A/B, RSV) erreichte das M10-System durchweg eine nahezu perfekte Übereinstimmung mit Sensitivitäts- und Spezifitätswerten zwischen 98% und 100%. Die Untersuchungen bestätigen die analytische Zuverlässigkeit für ein breites Spektrum, einschließlich sexuell übertragbarer Infektionen, High-Risk-HPV, Dengue-Viren und Monkeypox, wobei das System auch in anspruchsvollen Matrices wie bronchoalveolärer Lavage (BAL) exzellente Ergebnisse lieferte. Ein wesentlicher Vorteil gegenüber konventionellen Laborverfahren ist die signifikant verkürzte Zeit bis zum Ergebnis (Turnaround-Time), die je nach Assay zwischen 36 und 64 Minuten liegt. Dank des wartungsarmen Cartridge-Formats und der intuitiven Bedienung bietet das M10 eine rechtssichere und präzise molekularbiologische Diagnostik, die die Qualität eines Zentrallabors direkt in den patientennahen Bereich (Point-of-Care) überträgt.
"The STANDARD™ M10 STI Panel demonstrated diagnostic performance comparable to that of the Allplex™ STI Essential Assay for the six shared targets evaluated, with overall sensitivity and specificity values ranging between 98% and 100% and an almost perfect level of agreement, as indicated by Cohen’s kappa analysis. Minor differences observed for Neisseria gonorrhoeae, reflected by a slightly lower sensitivity (89.5%) and negative predictive value (94.4%), are likely attributable to the limited number of positive samples and low target concentrations rather than to systematic analytical limitations of the assay. The verification of manufacturer-declared limits of detection under local laboratory conditions further supports the analytical reliability of the STANDARD™ M10 STI Panel. In addition, its short turnaround time (approximately 64 min), cartridge-based format and random-access capability represent relevant operational advantages that may facilitate integration into routine diagnostic workflows requiring rapid and on-demand testing. While ongoing and future studies on larger and more balanced sample sets will further strengthen the available evidence, particularly for non-urine specimen types, the STANDARD™ M10 STI Panel represents a valuable, reliable and user-friendly molecular tool for STI diagnosis and surveillance in clinical practice."
"The M10Fast, developed for near-patient settings, reliably detects SARS-CoV-2, FluA, FluB, and RSV in 36 min and its performance is comparable to standard laboratory-based assays."
"The SD Biosensor Standard™ M10 HPV POCT and the Seegene Anyplex™ II HPV HR assay demonstrated almost perfect agreement in hrHPV detection and classification, supporting their complementary roles in cervical cancer prevention. M10's rapid, field-deployable design makes it suitable for resource-limited settings, while Anyplex provides enhanced genotyping capability in laboratory environments, allowing informed vaccine strategy. Incorporating both assays into cervical cancer prevention programs can improve screening coverage and accessibility, particularly in underserved areas. These findings align with the World Health Organization's cervical cancer elimination goals, reinforcing the importance of adaptable diagnostic tools in diverse healthcare contexts."
"Based on its commensurate performance to an established RT-PCR method combined with additional benefits of convenient storage and transport, easy use, and rapid processing, the Standard M10 DENV 1-4 system has potential for DENV detection and serotyping in point-of-care settings."
"The M10 OPX/MPX assay demonstrated its reliability in detecting MPXV infection, with high analytical sensitivity and in different biological matrixes, also allowing a rapid clade identification. Moreover, the rapid processing, the Point-of-Care approach, and being highly user-friendly make the platform an interesting means of testing for expanded diagnostic networks, in which resources and expertise might greatly differ across different laboratories: trustworthy and quick results are mandatory to put in place successful containment measures."
"In conclusion, the SMSCV represents a novel diagnostic tool for the rapid detection of SARS-CoV-2 in BAL samples with high sensitivity and specificity. The lower throughput of this POC method compared to other analytic systems (each instrument module can perform one sample at a time) meets the limited number of BAL sample requests compared with upper respiratory tract samples. Furthermore, this method could be useful in case of suspect of COVID-19 infection in critical patients admitted to critical care wards, and to prevent disease transmission in patients undergoing lung transplantation."
"The Novaplex MPXV Assay, the STANDARD M10 MPX/OPX, the RealCycler MONK-UX/MONK-GX v.2 and the RealStar Orthopoxvirus PCR Kit 1.0 demonstrated excellent diagnostic performance and are suitable for routine or rapid use in clinical laboratories to differentiate mpox from other rash diseases."
"In summary, the M10 assay effectively diagnosed SARS-CoV-2 infection, and its performance was comparable to the approved SARS-CoV-2 real-time PCR assay. It is a viable point-of-care test due to its short turnaround time."
The study demonstrates that the STANDARD M10 SARS-CoV-2 rapid RT-PCR assay provides a highly reliable diagnostic performance, showing an overall agreement of 99.5% when compared to conventional laboratory-based RT-PCR methods. By significantly reducing the turnaround time to just one hour through its user-friendly, cartridge-based system, the assay proves to be an efficient and accurate tool for emergency departments. Consequently, it facilitates rapid clinical decision-making and the effective management of isolation resources in high-pressure healthcare environments.
"STANDARD M10 Flu/RSV/SARS-CoV-2 is a reliable RT-PCR assay able to detect influenza A, influenza B, RSV and SARS-CoV-2 in one hour or less, fostering a rapid differential diagnosis of common respiratory viruses."
The study concludes that the STANDARD M10 assay is a highly accurate and efficient tool for the rapid molecular diagnosis of SARS-CoV-2, achieving 100% sensitivity and specificity in real-world testing. By delivering results in just 60 minutes - compared to the 270 minutes required by traditional methods - it significantly accelerates clinical decision-making. Furthermore, the assay proved fully compatible with both inactivated transport media for safe point-of-care use and lower respiratory tract specimens for critical care settings, making it a versatile and robust solution for both decentralized and intensive care environments.
