Positive Procedural Control
Monitor immunophenotyping by flow cytometry
CD-Chex Plus from Streck, Omaha, Neb, is a positive procedural control for monitoring immunophenotyping by flow cytometry. The control verifies the accuracy and reproducibility of all the Streck CD_Chex_Plussteps involved in the process of immunophenotyping, including red blood cell lysis. It provides assayed CD markers, including T lymphocytes, B lymphocytes, granulocytes, monocytes, and NK cells. The control is assayed for normal levels of CD34+ cells found in peripheral blood. CD-Chex Plus CD4 Low offers a depressed CD4 absolute number often indicated in patients with immunodeficiency diseases. Compatible with popular flow cytometry systems, CD-Chex Plus and CD-Chex CD4 Low are available in 2.5-mL and 3.0-mL cap-pierceable fill volumes. Both levels offer an open-vial stability of 30 days and a closed-vial stability of 90 days.
Streck
(800) 843-0912; www.streck.com

Spinal and Body Fluid Control
For evaluating accuracy, precision of hematology instruments
Cell-Chex Auto from Streck, Omaha, Neb, is a three-level spinal and body fluid control for evaluating the accuracy and precision of hematology instruments that measure blood cell counts in patient body fluid Streck Cell-Chex_Auto_Family_Line_2samples. The assay provides total red blood cell (RBC) and white blood cell (WBC) values for the following: Abbott CELL-DYN 3200, Sapphire and Ruby; Beckman Coulter LH 750/LH 755, LH 780, and UniCel DxH 800; and Sysmex XE-2100, XE-5000, XT-2000i, XT-1800i, and XT-4000i instruments. Two-part WBC differential assay values are also provided for the Sysmex XE-5000 and the XT-4000i. Cell-Chex Auto is packaged in a plastic 3.0-mL vial with a pierceable cap and has a 75-day closed-vial stability and a 30-day open-vial stability.
Streck
(800) 843-0912; www.streck.com

Whole Blood Sed-Rate Control
Monitor erythrocyte sedimentation rates
ESR-Chex from Streck, Omaha, Neb, is a whole blood sed-rate control for automated and manual methods. A two-level hematology control used to monitor erythrocyte sedimentation rates, it provides Streck ESR-Chexsuperior sed-rate accuracy, reacting to physical factors such as benchtop vibration, temperature, and tube angle. The product is manufactured from human red blood cells and verifies the precision and accuracy of manual and automated methods. It is assayed for the most frequently used sedimentation rate tubes in conjunction with the Classical Westergren, Modified Westergren, and Wintrobe methods. Automated and modified procedures do not require removal of sodium citrate, and the control is used in the same manner as a patient sample. ESR-Chex features a 12-month closed-vial stability and a 95-day open-vial stability.
Streck
(800) 843-0912; www.streck.com

Ethanol and Ammonia Test Control
Tests normal, elevated, and toxic concentrations
BioRad EthAmmoniaFamily_Oct12Liquichek™ ethanol/ammonia control from Bio-Rad Laboratories, Hercules, Calif, is a liquid control designed to monitor the precision of ethanol and ammonia test procedures in the clinical laboratory. This trilevel control offers normal, elevated, and toxic concentrations of ammonia in addition to ethanol. Two packaging configurations are available, including a 2.5-mL fill size that offers ready-to-use convenience on the Dimension Vista and 2D bar code technology for quick and easy product insert and vial label scanning. Point-of-care testing methods are included in the insert.
Bio-Rad Laboratories
(800) 224-6723; www.bio-rad.com

General Chemistry Testing
Tests 80 analytes
Liquid assayed and unassayed Multiqual® from Bio-Rad Laboratories, Hercules, Calif, are comprehensive, human serum-based quality controls, designed to provide unbiased third-party assessment of general chemistry testing. These liquid, ready-to-use products offer 80 analytes to monitor a wide variety of clinical chemistry testing. They contain HDL and LDL cholesterol and 11 commonly tested TDM analytes. Multiqual, available in assayed and unassayed configurations and multiple fill sizes, offers a 3-year shelf life when stored at -20°C to -70°C, and has a 14-day open-vial stability for most analytes when stored at 2ºC to 8ºC. It is now also available in a 2.5-mL fill size, covering more than 60 analytes.
Bio-Rad Laboratories
(800) 224-6723; www.bio-rad.com

Spinal Fluid Control
Two sizes available
BioRad SpinalFluidFamily_Nov12Liquichek™ spinal fluid control from Bio-Rad Laboratories, Hercules, Calif, is a liquid, bilevel product designed to monitor the precision of automated and manual procedures for the analysis of proteins and other critical analytes assayed in cerebrospinal fluid. Two fill sizes are available, including a 2.5-mL format with a 2D bar code that offers ready-to-use convenience on the Dimension Vista. Level 2 has oligoclonal banding. Peer group data may be available with the Unity Interlaboratory Program.
Bio-Rad Laboratories
(800) 224-6723; www.bio-rad.com

Homocysteine Control
Liquicheck HomocysteineMonitor homocysteine assay precision across range of target values
Liquichek™ Homocysteine Control is a trilevel, liquid human-serum based control from Bio-Rad Laboratories, Hercules, Calif. It was designed to monitor homocysteine assay precision across a wide range of target values (6.5, 12.0, 28 umol/L). It includes values on all three levels for automated immunoassays and HPLC. For platforms, mean values, and ranges, refer to the package inserts of currently available lots at myeinserts.com.
Bio-Rad Laboratories
(800)-224-6723; www.bio-rad.com

Urine Chemistry Control
Assayed for multiple analyzers
The new AUDIT MicroFD urine chemistry control, two levels, from AUDIT MicroControls Inc, Carlsbad, Calif, is intended to simulate human patient samples when monitoring the precision of laboratory testing AuditMicro FDTUrine_ChemistryControlprocedures for the following urine chemistry assays: amylase, calcium, chloride, creatinine, glucose, magnesium, microalbumin, microprotein, phosphorous, potassium, sodium, urea nitrogen, and uric acid. The control has been assayed for the following analyzers: Abbott Architect ci8200, Beckman AU680, Beckman DXC 600, Beckman DXC 800, Roche Cobas 6000, Roche Cobas 8000, Roche P-Modular, Siemens Advia 1800, Siemens Dimension RxL, and Siemens Dimension Xpand Plus. Each level is packaged as two sets of 5 mL by 3 mL. This lyophilized product has a shelf life of 2 years and a reconstituted stability of 6 days for set 1, and 10 days for set 2 when stored at 2°C to 8°C.
AUDIT MicroControls Inc
(760) 268-9796;? www.auditmicro.com

Glycohemoglobin A1c Control
Simulate human patient serum samples
Released last fall, the AUDIT MicroFD Glycohemoglobin A1c Control from AUDIT MicroControls Inc, AUDITMicro GlycoControlCarlsbad, Calif, is intended to simulate human patient serum samples when monitoring lab testing
procedures for Glycohemoglobin A1c. The control has been assayed for the following analyzers: Bio-Rad Variant II Turbo, Pointe Scientific Cobas Mira, Siemens Advia 1200, Siemens Dimension EXL, Siemens Dimension EXL 200, Tosoh G7, and Tosoh G8. Packaged as 8 mL by 0.5 mL, this lyophilized control has a shelf life of 2 years and an reconstituted stability of 7 days when stored at 2°C to 8°C.

AUDIT MicroControls Inc
(760) 268-9796;? www.auditmicro.com

Serum Protein Control
Simulate human patient serum samples
The new AUDIT MicroLQ serum protein control, two levels, from AUDIT MicroControls Inc, Carlsbad, Calif, is intended to simulate human patient serum samples when monitoring the laboratory testing AUDIT serumpro2procedures for albumin, alpha1-acid glycoprotein, alpha-1-antitrypsin, alpha2-macroglobulin, antithrombin, beta-2 microglobulin, ceruloplasmin, complement c3, complement c4, haptoglobin, immunoglobulin a, immunoglobulin e, immunoglobulin g, immunoglobulin m, prealbumin, total protein, and transferrin. The control has been assayed for Abbott Architect, Beckman DXC 800, Beckman Olympus AU680, Beckman Immage, Roche Cobas c501, Roche Cobas 6000, Roche Modular P, Siemens Dimension, and Siemens Dimension Xpand Plus. Packaged as 6 mL by 2 mL, this liquid product has a shelf life of 2 years and an open-vial stability of 60 days when stored at 2°C to 8°C.
AUDIT MicroControls Inc
(760) 268-9796;? www.auditmicro.com

Assayed Chemistry Control
Assayed for 35 different analytes
The qcCHEK assayed chemistry control from Quality Lab Solutions LLC, Oceanside, Calif, is a bilevel lyophilized control for in vitro diagnostic use as an assayed quality control material. The qcCHEK is QualityLab qcCHeckspecifically assayed for 35 different analytes, including apolipoprotein-A1 and B, high sensitive C-reactive protein (hsCRP), LDH-L, and LDH-P, and both TIBC and UIBC. The control is packaged in 5-mL vials, the product is available in two separate levels with 10 vials each, and it has a 10-day open-vial claim.
Quality Lab Solutions LLC
(760) 650-6003; www.qualitylabsolutions.com

Cardiac Control Marker
Available at three levels
The qcCHEK cardiac marker control from Quality Lab Solutions LLC, Oceanside, Calif, is a trilevel liquid, Quality Lab_Solutionsready-to-use control for in vitro diagnostic use as an assayed quality control material. It is assayed for
creatine kinase-MB (CK-MB), D-dimer, high sensitive C-reactive protein (hsCRP), myoglobin, troponin-I, troponin-T, and NT-proBNP. Packaged in 3-mL vials, the product is available as three separate levels with two vials each, and has a 30-day open-vial claim.

Quality Lab Solutions LLC
(760) 650-6003; www.qualitylabsolutions.com

Urine Chemistry Control
Liquid, ready to use
The qcCHEK urine chemistry control from Quality Lab Solutions, Oceanside, Calif, is a bilevel liquid, ready-to-use control for in vitro diagnostic use as an assayed quality control material. The control is assayed for Quality Lab_Solutionsamylase, calcium, chloride, cortisol, creatinine, hcg (for pregnancy), glucose, magnesium, microalbumin, microalbumin/creatinine ratio, osmolality, ph, phosphorus, potassium, sodium, specific gravity, total protein, urea nitrogen, and uric acid. It is packaged in 10-mL vials, it is available as two separate levels with six vials each, and it has a 90-day open-vial stability claim.
Quality Lab Solutions LLC
(760) 650-6003; www.qualitylabsolutions.com

Interlaboratory Electronic Quality Assurance Program
Updated product features direct uploading
The Interlaboratory Electronic Quality Assurance Program (eQAP) for chemistry and special chemistry from Beckman Coulter, Brea, Calif, enhances the routine daily internal quality control performed by the BeckmanCoulter eQAPControl_Photolaboratory. The program is offered for Beckman Coulter control products, including Synchron, Vigil Lipid, Ultimate-D Bilirubin, Ammonia/Alcohol, Vigil Protein, Vigil Serology, Vigil TDM, and Vigil HbA1c. The program provides monthly summary reports with grouping of laboratories by analyte, method principle, and analytical system, which includes UniCel, DxC Synchron, Clinical Systems, and IMMAGE Immunochemistry Systems. The introduction of UniCel DxC Operating Software Version 5.0 in October 2012 allows eQAP subscribers to submit QC data electronically by uploading it directly to the Beckman Coulter eQAP website using a USB.
Beckman Coulter
(800) 526-3821; www.beckmancoulter.com

QC Website Tool
Compare data with peers

CueSee Online from Eurotrol, Burlington, Mass, offers quality assurance of point-of-care testing programs Eurotrol CueSee_Online2and clinical outcomes. This interactive website tool compares quality control data of in vitro diagnostic tests with peers by using online summary reports, overall statistics, and graphical presentations. The service is free to all customers to use with Eurotrol products. Quality control and linearity result data are submitted via the website. Reports are then generated with options to customize and filter data to each user’s specifications and needs.
Eurotrol
(978) 598-3779; www.eurotrol.com

Blood Gas, Electrolyte, Metabolites, and Hematocrit Control
One product, one cartridge
CueSee VeriSTAT from Eurotrol, Burlington, Mass, is a new quality control and calibration verification Eurotrol _CueSeeVeriSTAT1material designed to help meet regulatory requirements. With enhanced features in addition to the original, all-in-one i-STAT control, it validates all blood gas, electrolyte, metabolites, and hematocrit with one product and one cartridge. The product is available in three clinically relevant levels of quality control as well as a five-level calibration verification kit. An added blue dye aids operators in dosing cartridges and helps eliminate costly sampling errors.
Eurotrol
(978) 598-3779; www.eurotrol.com

Asses Extra-Low pO2
Suitable for blood gas analyzers in multiple applications
Hypoxic QC from Eurotrol, Burlington, Mass, is a ready-to-use, pretonometered product used for Eurotrol _Hypoxic3assessing the accuracy and precision of extra-low pO2 values (~15 mmHg) on any blood gas analyzer. It helps meet regulatory requirements for validating the critical lower end of the reportable range for pO2. Having properties similar to patient samples, this highly commutable QC features active hemoglobin buffering with a 10-minute, open-ampule stability, making it well suited to perform method comparisons as well. The product is suitable for blood gas analyzers in the main lab, operating room, emergency department, and any point-of-care site.
Eurotrol
(978) 598-3779; www.eurotrol.com

Urinalysis quality controls
Comes with five configurations
Urinalysis Quality Controls from Quantimetrix, Redondo Beach, Calif, allow users to monitor the performance of urine dipsticks for visual and instrumental readings and microscopy. Five configurations
provide flexibility: Dipper urine dipstick control is designed to monitor the performance of visual and Quantimetrix UDCinstrumental readings of urine dipsticks by immersing the dipstick into the control—the same way users test patient samples. Dropper urine dipstick control features a dropper bottle for simple dispensing. Dropper Plus point-of-care urine dipstick control eliminates storage problems and provides maximum portability by providing 1 month of room-temperature stability—ideal for sites without refrigeration. Quantiscopics urine microscopics gives users a way to monitor the performance of urine microscopic analysis—also featuring squeeze bottles for simple dispensing. Dip & Spin urine dipstick/microscopics control is the most complete urinalysis control—two controls in one squeeze bottle for simple dispensing.

Quantimetrix
(310) 536-0006; www.quantimetrix.com

Urine Chemistry Control
Works with most major analyzers
Dropper Urine Chemistry Control from Quantimetrix, Redondo Beach, Calif, monitors the performance of Quantimetrix DropperUrineChemistryControlroutine and stat urine chemistry assay methods. This liquid, human urine-based control features a 2-year shelf life and open-vial stability from date of manufacture when stored at 2°C to 8°C. Users drop the control directly into the instrument sample cup. The dropper bottle provides simple dispensing and maximum use. The control is designed for use with most major chemistry analyzers including Abbott Architect, Advia, AU Series, Cobas, Dimension, Hitachi, Synchron, and Vitros, as well as for the Pyrogallol Red microprotein method and osmolality (freezing point method).
Quantimetrix
(310) 536-0006; www.quantimetrix.com

Microbumin Microalbumin Control
Monitors popular strips, immunoassays
Quantimetrix MicrobuminMicroalbuminControlMicrobumin Microalbumin control from Quantimetrix, Redondo Beach, Calif, monitors the performance of popular strips, including Clinitek Microalbumin reagent strips and Micral test strips. Microbumin can also be used with immunoassays such as Advia, Clinitek, DCA 2000, Dimension, Integra, Olympus, Synchron, and nephelometry. It features a 3-year refrigerated shelf life from date of manufacture, and 6-month open-vial stability when stored at 2°C to 8°C. The product is liquid, made with human urine, and includes creatinine.
Quantimetrix
(310) 536-0006; www.quantimetrix.com

Liquid Cardiac Control
Ready for point-of-care testing
The Randox Acusera liquid cardiac control from Randox, Kearneysville, WVa, comes in a ready-to-use format, ideal in point-of-care testing and for eliminating problems associated with reconstitution. Assayed-Randox AcuseraLiquid_Cardiacinstrument and method-specific target values are provided for nine cardiac markers including NT-proBNP, D-dimer, digoxin, and homocysteine. Three levels of control are available spanning the complete clinical range; low levels of troponin in the level 1 control mean there is no need to purchase additional, and often expensive, controls. An open-vial stability of 30 days at 2°C to 8°C for all analytes helps to minimize waste. The control is manufactured entirely from human serum, providing a matrix similar to the patient sample and reducing interference with antibody-based tests.
Randox
(304) 728-2890, toll free: 8664 RANDOX; www.Randox.com

Immunoassay Premium Plus Control
Method-specific values provided for 54 analytes
The Acusera Immunoassay premium plus control from Randox, Kearneysville, WVa, is a third-party Randox _Immunoassay_Premium_Pluscontrol with assayed-instrument and method-specific values provided for 54 analytes. The inclusion of routinely run tumor markers, therapeutic drugs, and other important parameters like intact PTH and vitamin D allow laboratories to consolidate their control use. Three clinically significant levels of control are available; both ferritin and vitamin B12 are present at levels suitable for anemia monitoring, while ultra-low TSH levels eliminate the need for additional controls. The control sample is made using 100% human serum, 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.
Randox
(304) 728-2890, toll free: 8664 RANDOX; www.Randox.com

 Assayed Chemistry Control
Values and ranges are provided for 70 parameters
The Randox Acusera assayed chemistry premium plus control from Randox, Kearneysville, WVa, is designed to monitor accuracy and precision. As a third-party control, it can be used alongside any Randox Clinical_Chemistry_Premium_Plusinstrument or method to provide an independent assessment of performance. Assayed method, instrument, and temperature-specific target values and ranges are provided for 70 parameters covering a wide range of lipids, cardiac markers, therapeutic drugs, immunoassays, and proteins, in addition to routine chemistries. Electrophoresis targets are also provided as a percentage breakdown of total protein. Once reconstituted, it is stable for 7 days at 2°C to 8°C, or 4 weeks at -20°C. A shelf life of up to 4 years enables long-term QC use.
Randox
(304) 728-2890, toll free: 8664 RANDOX; www.Randox.com

HCV Low Control
Verifies effective viral RNA extraction procedure
The AcroMetrix HCV Low Control from Life Technologies, Carlsbad, Calif, allows laboratories to monitor LifeTechnologies AcroMetrix_HCV_Low_Control_the lower limits of their hepatitis C virus (HCV) molecular assays. This quality control can be used across multiple test methods, enabling laboratories and manufacturers to accurately assess molecular testing procedures. The control has been formulated to mimic naturally occurring human specimens containing HCV, and the intact virus allows for verification of an effective viral RNA extraction procedure. It is designed to yield highly consistent results from lot to lot and is manufactured with traceability to the WHO International Standard for HCV RNA.
Life Technologies
(800) 955-6288; www.lifetechnologies.com

CT and NG Control
Independent, external quality control
For laboratories in need of an independent, external quality control for the molecular detection of LifeTechnologies AcroMetrix__CT.NG_Control_Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (NG), Life Technologies, Carlsbad, Calif, offers the new AcroMetrix CT/NG Control. This qualitative control, which was released in November 2012, allows laboratories to monitor assay performance over time, troubleshoot procedural errors, train laboratory personnel to accurately perform assays, and control the entire testing process, from extraction through amplification and detection. Daily use enables laboratories to monitor day-to-day test variation, lot-to-lot performance of test kits, and operator variation. The control contains intact, CT NG for verification of an effective nucleic acid extraction procedure.
Life Technologies
(800) 955-6288; www.lifetechnologies.com

Multi-Level Human Lipid Control
Exhibits identical behavior to serum/plasma tested
Multi-Level Human Lipid Control from Biocell, Rancho Dominguez, Calif, can be used with any available Biocellmethodology in the clinical lab. Biocell’s Bio-Lipid exhibits identical behavior to fresh patient specimen with no degradation and minimal oxidation of its lipid component when measured electrophoretically, eliminating matrix effects. The company’s process technology ensures that the lipids remain intact and stabilized in their native structure, providing a high level of assay performance for clinicians.
Biocell Laboratories
(800) 222-8382; www.biocell.com