Bio-Rad Laboratories, Inc.

Johnson & Johnson Medical Gmbh

Ethicon, Gmbh

Alireza Ebrahim

Karl De Vore

Christopher Spates

Henry K Hui

Leslie A Feldman

Nitu Kohli

Patricia A Antonoplos

Timothy Ho

James Cole

Warren Eric Vanderslice

Jayshree Parikh

Sholeh Zaminasli

Kristen Toblesky

John Sass

Douglas Kang

Eric Vanderslice

Methods are provided for end users of diagnostic measurement procedures to prepare quality controls having desired analyte recoveries, estimate recoveries of quality controls already prepared, and compare estimated and measured recoveries. To prepare a quality control containing a particular analyte, a desired recovery of a measurement procedure for the analyte can be scaled by a correlation factor to obtain a target nominal concentration of the analyte in the quality control. Alternatively, the nominal concentration of an analyte in a quality control can be scaled by a correlation factor to obtain a predicted recovery of a measurement procedure for the analyte. The correlation factors can be based on recovery data previously obtained using the measurement procedure and optionally one or more reference procedures, and can be calculated using regression analysis of these data. Each quality control can be prepared by dissolving a number of solid beads containing the analyte(s) of interest in a volume of base matrix.

Value assignment for customizable quality controls

Methods and devices for transferring materials between containers are discussed. One such connector includes: a base; a first elongate structure having first and second ends, the first elongate structure extending from a first side of the base at the first end to the second end distal the base, the second end forming a first opening sized and configured to receive a first container; a duct extending through the base and having a first tip skirted on one or more sides by the first elongate structure; a first guard positioned within the first elongate structure, wherein the first guard comprises a first surface, and the first surface is located further away from the base than the first tip. When the first container is moved into the first opening, the first surface moves toward the base, and the first tip enters the first container, creating a fluid path for the first container.

Connector for transferring the contents of a container

Provided herein are assay control materials comprising stable analytes and lyophilized unstable analytes, and methods of making and using the same.

Stabilization of labile analytes in reference materials

Solid beads each containing a selected quantity of analyte are combined and a liquid base matrix that contains attributes of a biological fluid that is to be assayed, together constitute a kit from which a laboratory technician can, at the point of use, prepare a liquid control for a particular analyte, and preferably a series of such controls at different levels of the same analyte customized for a particular assay.

Customized quality controls for analytical assays

A whole-blood-based substitute composition that is useful in coagulation assays as a standard, reference, control, calibrator, linearity verifier, or training material is prepared by combining a red blood cell lysate that is free of plasma, leukocytes, and platelets with a platelet-free plasma of human origin and an antimicrobial agent.

Standard/reference/control for blood coagulation testing

The present invention provides a cellular whole-blood D-dimer composition for use with diagnostic test procedures for D-dimer, and a method of its preparation. The composition comprises human erythrocytes and processed plasma to which D-dimer, and stabilizers, and optionally antimicrobial agents, are added and can be used as a standard and control for D-dimer testing.

Storage-stable cellular whole blood composition containing elevated amounts of D-dimer

An apparatus for determining exposure to an oxidative sterilant is described. The apparatus includes a chemical indicator for indicating exposure to the oxidative sterilant and a biological indicator for determining the effectiveness of the exposure to the oxidative sterilant. The chemical indicator has a metallic surface with a non-pH sensitive permanent indicator on the surface for indicating exposure to the oxidative sterilant. The chemical indicator may be on a self-contained biological indicator. The biological indicator and chemical indicator may be inside a test pack, where the test pack restricts sterilant flow to the indicators.

Apparatus with a chemical indicator for indicating exposure to an oxidative sterilant or disinfectant

Low-concentration reference controls for C-reactive protein assays are prepared from higher-level starting materials by simple filtration using silica-type filter media formerly used for removing lipids. This process avoids the need for antibodies to capture the protein and resuspend it. Surprisingly, the removal of CRP by the silica-type filter media is selective toward CRP, having little or negligible effect on other proteins in the starting matrix, and accordingly little or negligible change in the total protein content.

Reference control for high-sensitivity C-reactive protein testing

References, i.e., solutions of known concentration for use as controls, calibrators, or standards, for assays of carbohydrate-deficient transferring in bodily fluids are obtained from units of bodily fluids from normal healthy individuals by digesting the transferring in these units with exogenous neuraminidase to achieve concentrated CDT solutions, which are then added in preselected proportions to a base matrix to achieve target concentrations.

Growing community of inventors

Laguna Niguel, CA, United States of America

Alireza Ebrahim