​Positive Controls for Molecular Assays

Microbiologics, the leading provider of test ready biological controls, has all the controls your lab needs for validation, verification, proficiency and QC of molecular instruments and assays including:

   • Inactivated, full process controls
   • Synthetic nucleic acids, amplification and detection controls
   • Prepared microorganisms for culture methods
​   • QC Sets and Panels designed specifically for instrumentation and regulatory standards

Safe, Simple, Stable Molecular Controls

Helix Elite™ Molecular Standards, available in synthetic nucleic acid and inactivated formats, are non-hazardous controls designed for use with molecular assays.

   • Compatible with a variety of instruments, kits and applications
   • Convenient test-ready formats save you time and money
   • Easy and economical storage - room temperature storage
​   • FDA listed and CE Marked as an In-Vitro Diagnostic (IVD) Medical Device

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#8247     Respiratory Control Panel (22 Targets)  [NEW PRODUCT]
Respiratory Control Panel (22 Targets) contains six positive, pre-pooled inactivated pellets and six negative pellets (12 vials/pellets total). The negative control pellets are blank and do not contain microorganisms.

Positive Control (six vials/pellets):

• Adenovirus Type 6
• Bordetella parapertussis
• Bordetella pertussis
• Chlamydophila pneumoniae
• Coronavirus 229E
• Coronavirus HKU1 surrogate
• Coronavirus NL63 surrogate
• Coronavirus OC43 surrogate Strain 1 and Coronavirus OC43 surrogate Strain 2
• Human Metapneumovirus surrogate
• Human Rhinovirus
• Influenza A subtype H3N2

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• Influenza A subtype H1N1
• Influenza A subtype H1-2009
• Influenza A subtype H3
• Influenza B
• Mycoplasma pneumoniae
• Parainfluenza Virus 1
• Parainfluenza Virus 2
• Parainfluenza Virus 3
• Parainfluenza Virus 4a surrogate
• Respiratory Syncytial Virus
• SARS-CoV-2

Negative Control (six vials/pellets): Blank pellets

#8246   Simplified QC for COVID-19 & Common Respiratory Viruses 
 Microbiologics' new IVD Flu/RSV/SARS-CoV-2 Control Panel (Inactivated Swab) is designed to monitor the extraction, amplification, and detection of Influenza A, Influenza B, Respiratory Syncytial Virus, and SARS-CoV-2 molecular testing assays.

Contains six positive controls and six negative controls

• Positive control:
• Influenza A (H3N2) Virus
• Influenza A (H1N1) Virus
• Influenza B Virus
• Respiratory Syncytial Virus
• SARS-CoV-2 A549 Cells – lung epithelial cells
• Negative Control:
• Coxsackievirus B1
• A549 Cells – lung epithelial cells

Features

• Product is IVD and CE Marked
• Lyophilized Swab - Product stability and lower shipping costs 
• Room Temperature Storage - Saves on fridge space 
• IVD Controls and Panels providing assurance in your results 
• Swab format mimics the processing of a patient sample 
• Assay has an Internal Control; We Don’t Need an External Control 
• Single use reduces risk of contamination for multiple uses 
• QC portfolio 

 Catalog #   QC Respiratory Panels - click for link
​ 8246     Flu/RSV/SARS-CoV-2 Control Panel (Inactivated Swab) [NEW PRODUCT]
 8247     Respiratory Control Panel (22 Targets)  [NEW PRODUCT]
 8217     Respiratory (21 Targets) Control Panel
 8199    Cepheid Xpert® Respiratory Control Panel
 8190     Enterovirus (EV) Control Panel (Inactivated Swab)
 8219     Group A Streptococcus (GAS) Control Panel
 8206   Rifampicin-Resistant Mycobacterium tuberculosis Positive Control Panel (Inactivated Pellet)
 8238   Rifampicin-Resistant Mycobacterium tuberculosis Negative Control (Inactivated Pellet)
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For more Microbiologics respiratory controls, visit microbiologics.com.

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SARS-CoV-2 
​ 
​IVD Quality Controls & RUO Materials for Research

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COVID-19 has been a disruptive force worldwide. Diagnostic manufacturers and clinical laboratories have responded to the shear enormity of the pandemic with a proliferation of tests. For these molecular methodologies, providing an unbiased assessment of assay performance is critical. Microbiologics portfolio of SARS-CoV-2 quality controls provide laboratories with the confidence needed for their SARS-CoV-2 test results.
From virus research, through our Virology Services Team, to molecular IVD quality control materials, Microbiologics has been working with our customers since the outbreak to develop solutions to address the challenges of this new coronavirus.

**NEW - SARS-CoV-2 Process Controls and Inactivated Whole Virus Controls**

​Process Controls
Synthetic RNA encapsulated in a phage protein envelope containing diagnostically relevant
SARS-CoV-2 genomic targets - Orf 8/RdRP/S/M/E/N Gene Targets
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​HE0062S SARS-CoV-2 Process Control (Pellet)
HE0063S SARS-CoV-2 Process Control (Swab

Negative Controls
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Negative Controls containing A549 lung epithelial cells.
HE0058N  Negative Cellularity Control (Inactivated Pellet)
HE0067NS  Negative Cellularity Control (Inactivated Swab) 

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Synthetic Controls

Synthetic RNA material containing pooled genetic targets
HE0060S  SARS-CoV-2 Synthetic RNA (N Gene Targets)
HE0061S  SARS-CoV-2 Synthetic RNA (N/E/RdRp/S Gene Targets)

Inactivated Whole Virus Controls

Chemically inactivated Severe Acute Respiratory Syndrome Coronavirus 2 isolate
USA/WA1/2020 including A549 lung epithelial cells
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HE0065N  Inactivated SARS-CoV-2 Whole Virus (Pellet)
HE0066NS  Inactivated SARS-CoV-2 Whole Virus (Swab)

RUO SARS-CoV-2 Materials

High-titer SARS-CoV-2 solutions to meet your research and development or laboratory study needs
Synthetic RNA Solutions

• 9009 SARS-CoV-2 Synthetic RNA (N Gene Targets, 1 x 109 genome copies per tube)
• 9019VP SARS-CoV-2 Synthetic RNA (E/RdRp Gene Targets, 1 x 109 genome copies per tube)
• 9029VP SARS-CoV-2 Synthetic RNA (S Gene Targets, 1 x 109 genome copies per tube)

Inactivated Whole Virus Solutions

• 9101SD Inactivated SARS-CoV-2 Isolate USA-WA1/2020 109 genome copies /ml, 500µL tube
• 9102SD Inactivated SARS-CoV-2 Isolate USA-WA1/2020 108 genome copies /ml, 500µL tube
• 9103SD Inactivated SARS-CoV-2 Isolate USA-WA1/2020 107 genome copies /ml, 500µL tube
• 9201SD Inactivated SARS-CoV-2 Isolate Hong Kong/VM200001061/2020 109 genome copies /ml, 500µL tube
• 9202SD Inactivated SARS-CoV-2 Isolate Hong Kong/VM200001061/2020 108 genome copies /ml, 500µL tube
• 9203SD Inactivated SARS-CoV-2 Isolate Hong Kong/VM200001061/2020 107 genome copies /ml, 500µL tube

Additional SARS-CoV-2 Isolates are available upon request for Inactivated Whole Virus
RUO Material. Contact your Microbiologics representative: 858-824-9000

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