Kryptor Test

Brahms USA Inc, Annapolis, Md, has received FDA 510(k) clearance to market its patented Procalcitonin (PCT) Kryptor® test, an automated test used in critically ill patients on the first day of ICU admission as an aid to assess their risk for progression to severe sepsis and septic shock. The test helps enable ICU physicians to determine whether an infection is bacterial or viral and to provide information on the severity of a patient’s condition less than an hour after a blood sample is drawn. The assay measures concentrations between 0.02 and 5,000 ng/mL (0.02 to 50 ng/mL directly and up to 5000 ng/mL after sample dilution). It shows a high precision in the determination of serum/plasma PCT concentrations, and the intra-assay CV and the inter-assay CV are 2% to 3% on the whole PCT concentration range. The detection limit, calculated using the imprecision profile, has been assessed as being 0.019 ng/mL with a probability of 95%. The functional assay sensitivity (defined as the lowest analyte concentration that can be determined with an interassay CV <20) has been assessed as being 0.06 ng/mL with a probability of 95%. The antibodies used in this assay show no cross-reaction with human calcitonin (up to 2.5 ng/mL), human katacalcin (up to 10 ng/mL), human a-CGRP and ß-CGRP (up to 4 µg/mL).

Brahms USA Inc
(410) 897 9960
www.brahms-usa.com


Agentase CAD-Kit

Enzyme-based chemical agent point detection system

ICx Technologies, Arlington, Va, a developer of advanced sensor solutions for homeland security, force protection, and commercial applications, is offering of a new version of its popular Agentase™ CAD-Kit, an enzyme-based chemical agent point detection system. The version was designed for the commercial market—especially for first responders—and reflects their particular needs. The company has developed sensors that give EMS personnel and other first responders the ability to conduct surface, solid, and liquid examination of toxic industrial chemicals such as acids, bases, aldehydes, oxidizers, and nerve (G&V series), blood (AC), and blister (HD) agents. TIC accidents are faced by commercial end users, such as hospitals, hazardous materials teams, and EMS personnel, on a daily basis. The kit provides results in field environments, improves detection limits, and provides fast signals, and helps ensure the efficacy of hospital decontamination techniques. It is user friendly for the first responder community and provides low rates of false positives and negatives. Once a responder has identified the hazard present using the kit, individual sensors are used to verify the contamination of people, equipment, and the environment. The sensors can be used for testing post decontamination victims to confirm process efficiency and prevent cross contamination.

ICx Technologies
(703) 678-2111
www.icxt.com

T-Uptake Assay

Complete Thyroid Panel

With the introduction of its T-Uptake assay, Olympus America Inc, Center Valley, Pa, offers a complete thyroid panel for use with its AU3000i® immunoassay system, including TSH, T4, fT4, T3, fT3, and T-Uptake assays. The assay measures the saturation of thyroid hormone binding capacities in a patient specimen. For diagnostic purposes, T-Uptake results should be used in conjunction with an Olympus Total T4 determination to yield the FTI. Onboard stability for thyroid assays is 28 days, and turnaround time is 28 minutes to first result. AU3000i reagents feature 2D bar codes for secure and convenient onboard reagent management. The AU3000i system has throughput up to 240 tests per hour, random-access processing, magnetic-particle capture, and chemiluminescent detection.

Olympus America Inc
(800) 223-0125
www.olympusamerica.com

Fructosamine Reagent Application

For Olympus AU Series Analyzers

Pointe Scientific, Canton, Mich, has validated new reagent applications for the quantitative determination of Fructosamine for the Olympus AU series analyzers. The Fructosamine method is based on the ability of ketoamines to reduce NBT to a formazan dye under alkaline conditions. The rate of formazan development is directly proportional to the Fructosamine concentration (mmol/L) when measured at 550 nm. The reagent is linear to 8.5 mmol/L and has a reconstituted stability of 30 days refrigerated. Fructosamine provides a tighter 2- to 3-week evaluation in blood glucose control in comparison to Hemoglobin A1c, which provides a 6- to 8-week window. Fructosamine is important when bringing the diabetic patient into control of blood sugar levels.

Pointe Scientific
(800) 445-9853
www.pointescientific.com

Streck Cell Preservative

Maintains integrity of white blood cell antigenic sites

Streck, Omaha, Neb, has changed the name of its cell-stabilization reagent from Cyto-Chex® to Streck Cell Preservative™, to clearly identify the product and eliminate confusion with other products. The product is a liquid preservative for bone marrow aspirates, surgical tissue samples, fine needle aspirates, and peripheral blood, which maintains the integrity of white blood cell antigenic sites. Samples treated with the preservative are stable for up to 7 days prior to analysis by flow cytometry, allowing for transport and storage.

Streck
(800) 843-0912
www.streck.com

Para 12 and Para 12 Extend

Three-part differential control assay

The Para 12 and Para 12 Extend from Streck, Omaha, Neb, are now assayed for the Mindray BC-3200. Para 12 is a three-part differential control assayed for all parameters on the Coulter® STKR, J Series, T Series, Ac•T™/Ac•T diff™/Ac•T diff2™, MD Series, and ONYX Series; Abbott CELL-DYN® 1400, 1500, 1600, 1700, and 1800; Drew Datacell™ 18, Datacell 18MS/18MS Plus™, Datacell 16CP, and Excell™ 16; Infolab I-1800, I-1800MS/MS PLUS™, and I-1600; and the ABX Micros 60. Para 12 has a 110-day closed-vial stability, and a 14-day open-vial stability. It is available in a 2.5-mL vial or a 4.5-mL pierceable cap vial for instruments that have single, closed-vial sampling or continuous closed-vial auto-sampling capability. Para 12 Extend is a three-part differential control assay for all parameters on the Coulter STKR, J Series, T Series, Ac•T/Ac•T diff/Ac•T diff2, MD Series, and ONYX Series; Abbott CELL-DYN 1400, 1500, 1600, 1700, and 1800; ABX Micros 60; Diatron Abacus and Abacus Junior; and ERMA PCE-210. It is available in a 2.5-mL vial or a 4.5-mL pierceable cap vial, and offers a 30-day open-vial stability and a 6-month closed-vial stability.

Streck
(800) 843-0912
www.streck.com