Glycohemoglobin A1c Control
Bilevel assayed control
Audit® MicroFD™ Glycohemoglobin A1c Control from AUDIT MicroControls Inc, Carlsbad, Calif, is a bilevel assayed control consisting of human-based solutions. It is intended to simulate human patient whole blood samples for monitoring the precision of laboratory testing procedures for glycohemoglobin A1c assays. When used for quality control purposes, it is recommended that each laboratory establish its own means and acceptable ranges, and use the values provided only as guides. The solution is intended for use in clinical hospital labs, physician’s office labs, and clinical reference labs.
AUDIT MicroControls Inc
(760) 268-9796
www.auditmicro.com
Urine Dipstick Control
Liquid, human-urine–based product
The Dropper Plus from Quantimetrix Corp, Redondo Beach, Calif, is specifically designed for point-of-care dipstick control. Its 1-month room-temperature stability eliminates storage problems and provides maximum portability, which is suited for sites without refrigeration. A new feature is the addition of creatinine and microalbumin. Values are provided for all analytes; qualitative results for hCG for early pregnancy detection test methods are included. This control is intended for use with Multistix®, Chemstrip®, DiaScreen®, UriScan™, pH (Nitrazine paper), and other urinalysis reagent strips. It can also be used for confirmatory tests such as Acetest®, Clinitest®, Ictotest® reagent tablets, and refractometry. This product is liquid, human-urine–based, and comes with an 18-month unopened and open-vial stability when stored at 2ºC to 8ºC (from date of manufacture).
Quantimetrix Corp
(800) 624-8380
www.4qc.com
Assayed Chemistry Control
Human serum-based solutions
Audit® MicroFD™ Assayed Chemistry Control from AUDIT MicroControls Inc, Carlsbad, Calif, is a reference control consisting of human serum-based solutions. It is intended to simulate human patient serum samples for monitoring the precision of laboratory testing procedures for the following general chemistry assays: albumin, alkaline phosphatase, ALT (SGPT), amylase, AST (SGOT), BUN, calcium, chloride, cholesterol, CO2, creatine kinase (CK), creatinine, direct bilirubin, Gamma-GT, glucose, HDL cholesterol, iron, lactic acid, LDH, LDL cholesterol, lipase, magnesium, phosphorus, potassium, sodium, total bilirubin, total protein, triglycerides, and uric acid.
AUDIT MicroControls Inc
(760) 268-9796
www.auditmicro.com
Immunoassay Control
Simulates human patient serum samples
Audit® MicroFD™ Immunoassay Control from AUDIT MicroControls Inc, Carlsbad, Calif, is a reference control consisting of human-based serum. It is intended to simulate human patient serum samples for monitoring the precision of laboratory testing procedures for the following immunoassay assays: digoxin, estradiol, ferritin, folate, free T4, FSH, HCG, progesterone, LH, prolactin, testosterone, total PSA, total T3, total T4, TSH, and vitamin B12. When used for quality control purposes, it is recommended that each laboratory establish its own means and acceptable ranges, and use the values provided only as guides.
AUDIT MicroControls Inc
(760) 268-9796
www.auditmicro.com
Liquid Cardiac Control
Made from 100% human materials
The Acusera Liquid Cardiac Control from Randox Laboratories Ltd USA, Carnesville, WVa, comes in a ready-to-use format and is suited for use in point-of-care testing, while eliminating the problems associated with reconstitution. Instrument- and method-specific target values are provided for 10 cardiac markers, including BNP, NT-proBNP, D-dimer, and homocysteine. Three levels of control are available, spanning the complete clinical range. A working stability of 30 days at 2°C to 8°C minimizes waste and reduces costs. The liquid cardiac control is made from 100% human materials, providing a matrix similar to the patient sample and reducing interference with antibody-based tests.
Randox Laboratories Ltd USA
(866) 472-6369
www.randox.com
Vitamin D Control
Assayed, trilevel Vitamin D control
The Vitamin D Control from Fujirebio Diagnostics Inc, Malvern, Pa, is an assayed, trilevel vitamin D control containing both 25(OH) Vitamin D2 and 25(OH) vitamin D3. The control contains clinically relevant concentrations of 25(OH) vitamin D as well as excellent reconstitution stability of up to 14 days at 2°C to 8°C and 60 days at = -10°C. The control is stable for up to nine freeze/thaw cycles. Three levels of control are available to compare observations with expected ranges, therefore assuring consistent performance of the testing system within the clinical range.
Fujirebio Diagnostics Inc
(888) 499-9998
www.fdimcc.com
Specific Protein Control
Liquid, ready-to-use format
The Acusera Specific Protein control from Randox Laboratories Ltd USA, Carnesville, WVa, provides an assessment of performance. The liquid, ready-to-use format eliminates the possibility of reconstitution errors. Three levels of control are available with method-specific target values provided for 27 serum proteins, including RF, total and free kappa, and lambda light chains. A 2-year shelf life from the date of manufacture allows for long-term use and significantly reduces the costs and problems associated with changing lot number. Once opened, the material is stable for 30 days at 2°C to 8°C, reducing costs and minimizing waste. The specific protein control is manufactured from 100% human materials, meaning it won’t interfere with antibody-based tests.
Randox Laboratories Ltd USA
(866) 472-6369
www.randox.com
A1c Diabetes Control
Hemoglobin A1c quality control
Quantimetrix Corp, Redondo Beach, Calif, offers the Dropper A1c control for laboratory and point-of-care hemoglobin A1c quality control. The control offers 3 years of frozen (from date of manufacture) and 6 months of refrigerated open-vial stability. Twenty-one days of open-vial, room-temperature stability eliminates storage problems and provides portability. Dropper A1c control is designed for use with most major immunoassay and boronate affinity laboratory and POCT analyzers, including Siemens® DCA 2000/2000+/Vantage™ and Siemens Dimension, Beckman Coulter® Synchron®, Roche® cobas Integra®, Roche Hitachi, Ortho Clinical Diagnostics® Vitros®, and Primus Diagnostics PDQ/ultra2.
Quantimetrix Corp
(800) 624-8380
www.4qc.com
Immunoassay Premium Plus
Three levels of control
Randox Laboratories Ltd USA, Carnesville, WVa, offers the Acusera Immunoassay Premium Plus Control, a third-party control with instrument- and method-specific values provided for 54 analytes. The inclusion of routinely run tumor markers and other important parameters like intact PTH and vitamin D allows laboratories to dramatically consolidate their control use and, ultimately, save money. Three levels of control are available spanning the complete clinical range; both ferritin and vitamin B12 are present at levels suitable for anemia monitoring, while ultra-low TSH levels eliminate the need for a separate control. The control sample is manufactured from 100% human materials, providing a matrix similar to the patient sample and reducing interference due to antibody specificity. Once reconstituted, the material is stable for 7 days at 2°C to 8°C or 4 weeks at -20°C. The immunoassay offers a 3-year shelf life.
Randox Laboratories Ltd USA
(866) 472-6369
www.randox.com
VIROTROL I Control
Monitor assay precision
VIROTROL® I, from Bio-Rad Laboratories Inc, Irvine, Calif, is a liquid, human-serum–based quality control, providing laboratories with the ability to monitor assay precision. With a long shelf life and open-vial stability, this product is packaged in several configurations, including tubes that are compatible with most automated systems. Analytes include anti-CMV, anti-HBc, anti-HCV, anti-HIV-1, anti-HTLV-1, and HBsAg. It is intended for use in clinical laboratories and blood donor screening facilities.
Bio-Rad Laboratories Inc
(800) 224-6723
www.bio-rad.com/idcontrols
Tumor Marker Control
Contains the novel biomarker HE4
Fujirebio Diagnostics Inc, Malvern, Pa, offers Tumor Marker Control, a multiconstituent control that contains the novel biomarker HE4. In addition, the control contains AFP, CEA, CA15-3, CA19-9, CA125, ferritin, PSA, and free PSA. This control is a 100% human serum matrix, assayed, bilevel tumor marker panel containing clinically relevant proportions of the subfractions free PSA and PSA-ACT, as well as excellent reconstitution stability of up to 60 days at = -20°C. The control is stable for up to nine freeze/thaw cycles. Two levels of control are available to compare observations with expected ranges, assuring consistent performance of the testing system within the clinical range.
Fujirebio Diagnostics Inc
(888) 499-9998
www.fdimcc.com
Data Management System
Simplify decentralized testing
Siemens Healthcare Diagnostics Inc, Tarrytown, NY, offers the RAPIDComm® 4.0 Data Management System, which is designed to work with Siemens’ blood gas, diabetes care, and urine chemistry analyzers. The RAPIDComm system’s connectivity and process management capabilities enhance and simplify decentralized testing. The system includes safeguards to improve patient care. It also allows users to define critical ranges and set trend alerts for test results. Users are capable of reviewing results by exception to focus attention on critical areas. Other features include analyzer and point-of-care program management, centralized operator management, and multiple documentation and security features.
Siemens Healthcare Diagnostics Inc
(914) 631-8000
www.siemens.com/rapidcomm
Rheumatoid Factor Reagent
Uses an immunoturbidimetric method
Carolina Liquid Chemistries Corp, Winston-Salem, NC, offers Rheumatoid Factor packaged in ready-to-use cartridges for use on Beckman® SYNCHRON CX, LX, and DxC clinical chemistry analyzers. This assay uses an immunoturbidimetric method. The reagent is stable until its expiration date and 30 days when on the instrument. Calibration is stable for 7 days. Rheumatoid reagent is intended for the quantitative determination of human rheumatoid factor in serum using the Beckman SYNCHRON Clinical Systems. Rheumatoid factor, an autoimmune antibody in the patient’s serum, interacts with the aggregated human IgG in the reagent, forming immune complexes. The immune complexes cause an increase in light scattering, which correlates with the concentration of serum rheumatoid factor.
Carolina Liquid Chemistries Corp
(877) 722-8910
www.carolinachemistries.com
Urine Toxicology Control
Available drug-free and high positive levels
The new MAS® DOA TOTAL control from Thermo Fisher Scientific, Fremont, Calif, is a multiconstituent urine toxicology control offering 19 analytes with four distinct levels at drug concentrations 25% above and below commonly used screening and SAMHSA cutoffs. A drug-free level and high positive level are also available (six levels total). The MAS DOA TOTAL control is a liquid, ready-to-use product available for use on a variety of instrument platforms. Each level of control is individually packed, which allows the flexibility to choose a level according to drug screen panel cutoffs while keeping the number of control vials to a minimum.
Thermo Fisher Scientific
(800) 232-3342
www.thermoscientific.com/QC
Spinal Fluid Cell Count Control
One-month open-vial stability at room temperature
Quantimetrix Corp, Redondo Beach, Calif, offers Spinalscopics spinal fluid cell count control to monitor the performance of red and white blood cell count methods in cerebrospinal fluid samples performed manually using a hemocytometer. A dropper dispenser is provided for ease of use. The control has an 18-month unopened and a 6-month open-vial stability when stored at 2ºC to 8°C, as well as a 1-month open-vial stability at room temperature.
Quantimetrix Corp
(800) 624-8380
www.4qc.com
Low and High Plasma Controls
Assess performance of nucleic acid test procedures
The AcroMetrix® EBV low and high plasma controls from Life Technologies Corp, Carlsbad, Calif, are intended for use in assessing the performance of nucleic acid test procedures for the determination of human Epstein-Barr Virus (EBV) DNA. These controls are designed and manufactured according to ISO 17511, they are assigned traceable values with uncertainty measurements, and are consistent from lot to lot. The EBV plasma controls effectively mimic authentic patient samples, consisting of whole, unaltered EBV in an EDTA plasma. Developed for use on multiple extraction and amplification systems, the EBV plasma controls allow labs to control for the entire molecular testing process from sample to result. AcroMetrix EBV Plasma Controls are for in vitro diagnostic use in the United States.
Life Technologies Corp
(760) 603-7200
www.lifetechnologies.com
Liquichek Immunoassay Control
Liquid, human-serum–based control
Bio-Rad Laboratories Inc, Irvine, Calif, offers the Liquichek Specialty Immunoassay Control, a liquid, human-serum–based control with a comprehensive menu that includes 25-OH vitamin D, iPTH, anti-TPO, and anti-Tg. The 25-OH vitamin D insert listing has expanded to include all major automated methods as well as LC-MS-MS values for vitamins D2 and D3. The control offers long open-vial stability and multianalytes. Using Liquichek Specialty Immunoassay Control with the company’s Unity™ software enables significant analytical capabilities and a comprehensive interlaboratory comparison.
Bio-Rad Laboratories Inc
(800) 224-6723
www.bio-rad.com/iacontrols
