Quality Controls

The Quality control of analytical methods is critical in the maintenance of good clinical laboratory practices. Quality control in a microbiological laboratory requires the use of known strains. All our control strains have been isolated from clinical specimens and characterized according to standard methods.

Products

Seracare Serology Controls

ACCURUN serology controls have been a long trusted source of reliable and consistent QC material for clinical laboratories worldwide. SeraCare’s ACCURUN controls are weakly reactive to help challenge your serology assays and provide additional confidence in your laboratory test results. Monitoring your assay performance can help you avoid costly repeats and, more importantly, avoid false-negative and false-positive results. With ACCURUN controls, you can troubleshoot your test methods and isolate system errors in your laboratory.

  • Mimics a patient sample, therefore treated like a patient sample, reducing additional steps in your workflow
  • Reliable and ready-to-use, eliminates the hassle of locating external controls to meet laboratory compliance requirements
  • Single-analyte and multi-analyte formats offer you cost-effective options to conserve your laboratory budget

Challenges your assay more effectively
A low positive control challenges your assay more than a medium-to-high control since it is closer to the assay cut-off; therefore, any variability in the assay will be easier to detect. Assay monitoring with ACCURUN single and multi-analyte controls improves confidence in your serology test results.

ACCURUN Controls

Consistent accuracy is non-negotiable.

Serology Controls

  • Specifically formulated as a low level positive sample for manual and automated platforms
  • Ready to use—no reconstitution or special handling required; most stable at refrigerated temperatures
  • Enable your lab to meet compliance requirements of regulatory agencies and professional organizations

 

Nucleic Acid Controls: our comprehensive line of PCR and hybrid-capture

NAT controls are formulated using intact virus or microorganisms

  • Help your lab monitor all aspects of sample testing—sample lysis and extraction through target or signal amplification to detection
  • Formulated at different levels to effectively challenge assay performance and monitor results at clinical decision points

 

Genetic Controls: setting a new standard for error detection

  • Muliple alleles per vial allow your lab to run more samples and fewer controls
    • Optimizes instrument capacity, especially for multiplexed assays
  • Eliminate more test errors, run more samples and fewer controls

Cycler Validation

Validation tools for testing PCR thermal cyclers according to legal requirements

Validation tools for testing PCR thermal cyclers according to legal requirements

 Thermal Cycler Validation Kits available for both conventional endpoint PCR and real-time PCR (qPCR) cyclers False negative PCR results are highly critical and might be caused by a defect PCR cycler. Verification of the correct temperature control of the used equipment is usually a stressful issue. To comply with quality management systems is not easy to fulfill for PCR cyclers.

Principle

The Traditional/qPCR Thermal Cycler Validation Kits provide temperature sensitive PCR reactions to monitor an upper and lower temperature range in one run. The primer sequences in the Traditional Thermal Cycler Validiation Kit respectively the primer/probe sequences in the qPCR Thermal Cycler Validation Kit in combination with a regular PCR protocol were designed to react extremely sensitive to incorrect temperature control, temperature homogeneity, precision and timing. Amplification will completely drop out at temperature differences of more than 2 °C. The cycler performance is tested at standard PCR settings to reflect most users applications. In addition, the pre-adjusted target concentrations are only amplified at high PCR efficiencies as an additional indicator for accurate temperature control of the thermal cycler.

Benefits

  • No extra equipment, instrument or software needed.
  • Applicable with any block PCR cycler or qPCR cycler used in a research or industrial quality assurance lab for the reliability testing of instrument performance and reliability.
  • In the qPCR Thermal Cycler Validiation Kit the probes of each amplification system are labeled with different fluorescent dyes (FAM™ and ROX™) to allow individual evaluation of each temperature range.
  • Includes all you need: Freeze-dried primer/probe sets, polymerase, nucleotides and rehydration buffer

Cat.-No. 57-2102
Traditional Thermal Cylcer Validation Kit (6 strips, 8 vials each)

Cat.-No. 57-2103
Traditional Thermal Cylcer Validation Kit (100 reactions)

PCR Thermal Cycler Color Compensation Kit

For real-time PCR (qPCR) thermal cyclers with optical unit equipped with filter sets for FAM™ and ROX™

Description

As real-time qPCR cyclers may vary in their fluorescence detection sensitivity, color compensation experiments must be performed on each specific multiplex PCR instrument. The Color Compensation Kit is designed for generating color compensation files on qPCR cyclers to allow proper interpretation of multiplex experiments. To generate a color compensation object, the labeled calibration dyes are used in an initial color compensation run. The calibration dyes contain labeled oligonucleotides for the determination of crosstalk corresponding to each individual dye being used in a multiplex assay, and a blank reaction buffer without dye for the determination of background fluorescence of the buffer. The result evaluation is performed by measuring the fluorescence signal with your qPCR cycler.

Kit Components

  • Freeze-dried calibration dyes for 3 different wavelengths (FAM, ROX and VIC)
  • Rehydration Buffer

Cat.-No. 57-0010
10 calibrations (25 μl each)

SERO Autonorm Human Liquid

SERO Autonorm Human Liquid

  • Complete human-based clinical chemistry control, including clinical chemistry analytes, lipids, enzymes, proteins, hormones, cardiac markers and drugs
  • Product documentation with approximate value list for more than 50 components including genuine lipids, proteins (e.g. CRP, Apo A1 and Apo B) and therapeutic drugs
  • Available in 2 clinically relevant levels, each level available separately
  • Liquid – ready to use!
  • Opened vials stable for 14 days at 2-8 °C
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SERO Pathonorm

Pathonorm

  • Animal-based control serum for accuracy control in the clinical chemistry field
  • Product documentation with analytical data for more than 40 of the most important components in clinical chemistry
  • Independent and traceable values
  • Available in 2 clinically relevant levels (L/H), below the reference range (L) and at a pathologically high level (H). Both levels available separately
  • Freeze-dried material, offering long shelf life
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SERO Seronorm Cardiac Acute Liq

SERO Seronorm Cardiac Acute Liq

  • Seronorm Cardiac Acute Liq is the most complete acute control on the market combining the complete panel of cardiac markers and acute markers to rule out life threatening conditions such as sepsis, brain trauma, thrombosis and ectopic pregnancy.
  • The product is a liquid material based on human serum
  • Product documentation is provided with assigned values for all components on the most frequently used clinical laboratory and point-of-care test systems on the market.
  • As a result of lack of standardization, the various methods for the markers Troponin I, NT-proBNP and BNP give widely different results. To achieve better control of these critical markers in your laboratory, the new low level is available in two variants (L-1A and L-1B) to ensure relevant levels in the various platforms.
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SERO Seronorm Human

Seronorm Human

  • Multi component human-based accuracy control covering most components for the clinical chemistry platform
  • Product documentation with assigned values on 60 components, including genuine lipids, routine clinical chemistry analytes, enzymes, proteins, hormones, cardiac markers and drugs
  • Traceable values to reference methods for many of the components
  • Two clinically relevant levels – each level available separately
  • Freeze-dried material, offering long shelf life
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