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IntelliPlex™ SARS-CoV-2 Detection Kit
ADVANTAGES
Process up to 564 samples within 8 hours.Simultaneously detected 3 genes (E, N and RdRp) in SARS-CoV-2 to mitigate the probability of false negative results due to the fast-evolving pace of this virus.
SARS-CoV-2
PRODUCT HIGHLIGHTS INSTRUMENTATION SPECIMEN
� Single-well multiplex detection for three genes of SARS-CoV-2
� High sensitivity(LoD: 140 copies/ mL) � High throughput
(564 samples within 8 hours)
� MiniAmpTM Thermal Cycler � IntelliPlex™ 1000 πCode Processor
� PlexBio™ 100 Fluorescent Analyzer
� Nasopharyngeal swab
Detection Target
N, RdRp and E gene of SARS-CoV-2 RNA extracted from Nasopharyngeal swab specimens
The IntelliPlexTM SARS-CoV-2 Detection Kit is a qualitative detection of SARS-CoV-2 virus in patients that may or may not exhibit symptoms of respiratory tract infection (i.e. fever, cough, shortness of breath). Based on the πCodeTM technology and PlexBio’s instrument platform, the kit detects the presence of N, RdRp, and E genes of SARS-CoV-2 in RNA extracted from nasopharyngeal swab specimen. One or more positive target genes detection are indicative of the presnce of SARS-CoV-2.
Confirmed Specimen
Positive* Negative
P e
ee
30 0
e e
0 30
30 30
IntelliPlexTM SARS-CoV-2 Detection Kit
100%
100 %
Clincal Sensitivity a
Clincal Specificity b
Positive
Negative
Total
ORDER INFORMATION
ASSAY KIT IntelliPlex™ SARS-CoV-2 Detection Kit 8230396 rxns
General Info : [email protected]
Order Info : [email protected]
PERFORMANCE DATA
ASSAY WORKFLOW
A seamless multiplexing workflow results in highly sensitive SARS-CoV-2 detection with minimal hands on time.
IntelliPlex 1000 πCode Processor PlexBio 100 Fluorescent Analyzer Thermocycler
Amplification Hybridization Washing SA-PE Dispensing Detection
CATEGORYCATEGORY CAT. NOCAT. NOPACKAGE VOLUMEPACKAGE VOLUMEPRODUCT NAMEPRODUCT NAME
a Clinical Sensitivity = True Positives / (True Positives + False Negatives) x 100%
b Clinical Specificity = True Negatives / (True Negatives + False Positives) x 100%
INSTRUMENT IntelliPlex™ 1000 πCode Processor 800331 unit
INSTRUMENT PlexBio™ 100 Fluorescent Analyzer 800001 unit
* The test was done with contrived positive specimen with SARS-CoV-2 at ~ 1 x LoD (20 samples) and ~2 x LoD (10 samples)
The IntelliPlexTM SARS-CoV-2 Detection Kit is intended for in vitro diagnostic use in Europe (CE-IVD). The assay kit is also available in the United States as an IVD product under US FDA
Emergency Use Authorization guidelines applicable during the course of the Covid-19 pandemic. The product is available as Research Use Only (RUO) solution, not for use in diagnostic
procedures, in all other territories worldwide. ©2020 PlexBio Co., Ltd. All rights reserved. All trademarks are the property of PlexBio Co., Ltd.
