
Controls
Molecular and Process Controls for Infectious Disease Assays
DiaSorin Molecular offers Simplexa® Molecular and Process Controls for use in infectious disease molecular assays. Simplexa® Process Controls are used to detect systemic variation that may arise during the extraction and amplification steps of real time PCR assays. Simplexa® Molecular Controls are offered for a range of infectious disease targets.
Molecular Controls
Simplexa® Adenovirus Molecular Control
Consists of inactivated adenovirus in human base matrix.
Simplexa® BKV Molecular Control
Consists of a DNA fragment to a well conserved region of BKV VP2 gene in human base matrix.
Simplexa® Bordetella Molecular Control
Consists of a 625 bp DNA fragment containing both the IS481 and IS1001 target regions.
Simplexa® Bordetella Positive Control Pack
Consists of inactivated Bordetella bacteria
Simplexa® C. difficile Positive Control Pack
Consists of inactivated C. difficile bacteria.
Simplexa® CMV Molecular Control
Consists of a DNA fragment containing a well conserved region of CMV UL83 gene in human base matrix.
Simplexa® Congenital CMV Positive Control Pack
Consists of inactivated cytomegalovirus.
Simplexa® COVID-19 & Flu A/B Positive Control Pack
Consists of inactivated SARS-CoV-2 virus, inactivated influenza A virus, and inactivated influenza B virus.
Simplexa® COVID-19 Positive Control Pack
Consists of synthetic gene fragments for SARS-CoV-2 ORF1ab and S gene target regions in UTM.
The Simplexa COVID-19 Direct test has not been FDA cleared or approved. The test has been authorized by FDA under an EUA for use by authorized laboratories. The test has been authorized only for the detection of nucleic acid from SARS-CoV-2, not for any other viruses or pathogens. The Simplexa COVID-19 Direct test is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostic tests for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Act, 21U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.
Simplexa® Dengue Molecular Control
Consists of inactivated Dengue virus including serotypes 1, 2, 3 and 4.
Simplexa® EBV Molecular Control
Consists of a DNA fragment to a well conserved region of EBV LMP2A gene in human base matrix.
Simplexa® Flu A/B & RSV Positive Control Pack
Consists of inactivated influenza A virus, inactivated influenza B virus, and inactivated RSV.
Simplexa® GBS Positive Control Pack
Consists of inactivated Group B Streptococcus bacteria.
Simplexa® Group A Strep Molecular Control
Consists of inactivated Group A Streptococcus (GAS) bacteria.
Simplexa® Group A Strep Positive Control Pack
Consists of inactivated Group A Streptococcus (GAS) bacteria.
Simplexa® HSV 1 & 2 Positive Control Pack
Consists of inactivated HSV 1 & 2 viruses.
Simplexa® SARS-CoV-2 Variants Positive Control Pack (RUO)
Inactivated SARS-CoV-2 viral particles.
For Research Use Only. Not for use in diagnostic procedures.
Simplexa® VZV Positive Control Pack
Consists of inactivated varicella-zoster virus.
Process Controls
Simplexa® Extraction and Amplification Control Set
This set consists of a DNA template and labeled primer pair intended to be used as a process control to detect systemic variation that may arise during the extraction and amplification steps of real-time polymerase chain reaction (PCR) assays. The set is not intended to monitor other real-time PCR processes.
Simplexa® Extraction and Amplification Control Set – RNA
This set consists of a RNA template and a labeled primer pair intended to be used as a process control to detect systemic variation that may arise during the extraction and amplification steps of real-time reverse transcription polymerase chain reaction (RT-PCR) assays. The set is not intended to monitor other real-time PCR processes.
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