Controls
Vitamin D Control receives FDA clearance
The Vitamin D Control contains both 25(OH) Vitamin D2 and 25(OH) Vitamin D3 and is intended for use as a quantitative, assayed serum control. It has excellent stability, value assignment across platforms, and clinically relevant levels which enables the laboratory to monitor the precision of its Vitamin D assays.
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Fujirebio Diagnostics
Verify the accuracy and linear reportable range of the reticulocyte parameter
The accuracy of hematology instruments can be verified by comparing the laboratory’s reportable range with Retic-Chex Linearity assays, which include instrument-specific values for reticulocyte percentages. Verification may be necessary when any one of the following occurs: a new instrument is introduced into the lab; daily controls reflect an unusual trend or shift outside the lab’s acceptable limits; a complete change of reagents; major preventive maintenance occurs; or essential parts are replaced. Retic-Chex Linearity is available in five-vial sets with values assigned for a variety of systems. Available in 3.0-mL plastic cap-pierceable vials, the product offers a closed-vial stability of 105 days and an open-vial stability of five days.
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Streck
Glucose control compatible with point-of-care devices
GlucoTrol-WB, a real blood-glucose control, is packaged with ACU-CAP, a device that enables separation of real blood cells from a plasma fraction containing glucose, thereby eliminating glycolysis. The control is highly commutable and compatible with all point-of-care glucose devices, with minimal matrix effects. Performance of all levels of this control yield low imprecision, comparable with the imprecision of human whole blood. ACU-CAP also eliminates the need for pipetting. GlucoTrol-WB can be used for quality control, for method comparisions or validations, or for proficiency testing.
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Eurotrol
HbA1c control with intact RBCs
A1c-Cellular, an HbA1c control with intact red blood cells (RBCs), tests the entire HbA1c procedure, including the lysing of the RBC. This step ensures the entire system — instrument and reagents — is working properly to provide accurate patient results. The control does not need to be reconstituted — which eliminates the potential for human error due to incorrect pipetting during reconstitution — and is convenient to use. The product is appropriate for immunoassay and ionic exchange high-performance liquid chromatography, or HPLC, methodologies and is available in 2.0-mL plastic screw-top cap-pierceable vials.
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Streck
Precision monitoring of tumor-marker assays
Tumor Marker Control is intended for use as an assayed control serum to monitor the precision of laboratory-testing procedures for the analysis of AFP, CA 15-3, CA 19-9, CA 125, CEA, Ferritin, HE4, PSA, and Free PSA. The multi-constituent control contains the novel ovarian biomarker HE4, which is used to monitor for progression and recurrence of epithelial ovarian carcinoma. In addition, this control contains clinically relevant proportions of free PSA and PSA-ACT. Tumor Marker Control is lyophilized, 100% human serum matrix, stable for up to nine freeze/thaw cycles with reconstituted stability up to 60 days at <-20°C.
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Fujirebio Diagnostics
Cystic fibrosis control panel
INTROL CF Panel II is designed to monitor the detection of 54 CFTR mutations, genetic risk factors associated with cystic fibrosis. The mutations include the 23 mutations recommended for testing by ACMG and ACOG, and are contained in three bottles in heterozygous format. INTROL controls are manufactured from synthetic DNA suspended in a patented, non-infectious, blood-like matrix. Each control bottle contains two synthetic alleles in mimic of genomic DNA. When used routinely with traditional tools such as Levey-Jennings charts and Westgard Rules, the laboratory is alerted to test system errors so corrective action can be performed before system failures occur.
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Maine Molecular Quality Controls
Group B Strep positive control
A standardized control for the qualitative molecular testing of Group B Streptococcus (GBS),
OptiQual GBS Positive Control helps laboratories assess the performance of testing procedures and ensure the quality of results. Laboratories use this control to monitor variation in assay performance over time and among test-kit lots, and to identify increases in random and systematic error. Provided in ready-to-use liquid form, it can either be pipetted directly into the assay system or used with a swab. This product contains whole, intact bacteria and is designed to mimic naturally occurring human specimens containing GBS and is for in vitro diagnostic use.
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AcroMetrix
New 5-mL dropper configuration
A 5-mL dropper bottle option is available for
AmpliTrol III. This product is designed for use by nucleic-acid testing (NAT) labs with qualitative in vitro diagnostic procedures for the detection of HIV-1, HBV, and HCV nucleic acids in human serum or plasma from donations of whole blood and blood components for transfusion. AmpliTrol III is a full-process positive control, used in the same manner as a patient specimen, to monitor sample preparation, amplification, and detection procedures with many commercially available NAT systems. Sizes available include single-use 1 mL and 5 mL with 60-day open-vial stability.
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Bio-Rad Laboratories