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.

Code Volume
MOL8011 2 x 250 µL

Simplexa® BKV Molecular Control

Consists of a DNA fragment to a well conserved region of BKV VP2 gene in human base matrix.

Code Volume
MOL8009 2 x 250 µL

Simplexa® Bordetella Molecular Control

Consists of a 625 bp DNA fragment containing both the IS481 and IS1001 target regions.

Code Volume
MOL8006 2 x 50 µL

Simplexa® Bordetella Positive Control Pack

Consists of inactivated Bordetella bacteria

Code Quantity
MOL2760 10

Simplexa® C. difficile Positive Control Pack

Consists of inactivated C. difficile bacteria.

Code Quantity
MOL2960 10

Simplexa® CMV Molecular Control

Consists of a DNA fragment containing a well conserved region of CMV UL83 gene in human base matrix.

Code Volume
MOL8002 2 x 250 µL

Simplexa® Congenital CMV Positive Control Pack

Consists of inactivated cytomegalovirus.

Code Quantity
MOL2265 10

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.

Code Quantity
MOL4260 10

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.

Code Quantity
MOL4160 10

Simplexa® Dengue Molecular Control

Consists of inactivated Dengue virus including serotypes 1, 2, 3 and 4.

Code Volume
MOL3103C 2 x 800 µL

Simplexa® EBV Molecular Control

Consists of a DNA fragment to a well conserved region of EBV LMP2A gene in human base matrix.

Code Volume
MOL8008 2 x 250 µL

Simplexa® Flu A/B & RSV Positive Control Pack

Consists of inactivated influenza A virus, inactivated influenza B virus, and inactivated RSV.

Code Quantity
MOL2660 10

Simplexa® GBS Positive Control Pack

Consists of inactivated Group B Streptococcus bacteria.

Code Quantity
MOL3560 10

Simplexa® Group A Strep Molecular Control

Consists of inactivated Group A Streptococcus (GAS) bacteria.

Code Volume
MOL8033 1 x 100 µL

Simplexa® Group A Strep Positive Control Pack

Consists of inactivated Group A Streptococcus (GAS) bacteria.

Code Quantity
MOL2860 10

Simplexa® HSV 1 & 2 Positive Control Pack

Consists of inactivated HSV 1 & 2 viruses.

Code Quantity
MOL2160 10

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.

Code Quantity
MOL4360 10

Simplexa® VZV Positive Control Pack

Consists of inactivated varicella-zoster virus.

Code Quantity
MOL3660 10

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.

Code Volume
MOL9000 100
MOL9300 1000

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.

Code Volume
MOL9200 100

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