Abstract: The invention is a method for detecting failures in an analyzer for conducting clinical assays. Potential errors that can result in assay failures in an analyzer are identified, as are their potential sources. The probability that an error source so identified will result in a clinically significant error is also determined. Available potential detection measures corresponding to the source of potential errors are identified with a combination of such measures selected and implemented based on their probability of detecting such errors within an acceptable limit with a concomitant low probability of the false detection of an assay failure. Each of the measures selected are functionally independent of others chosen to address the source of the error and are not subject to the same inherent means of failed detection. Applications of the method in a clinical analyzer are also presented.

Abstract: A method and apparatus for providing a non-destructive pre-test screen of specimen integrity for a blood analyzer by measurement of absorbance or reflectance is provided. The method involves measurement of polychromatic light in the near infrared and adjacent visible region, which is either transmitted or reflected from a specimen as presented for measurement, and correlation of the measurement, on the basis of predetermined algorithms, to the quantity of a known substance contained in the sample. The apparatus employs a spectrophotometer which emits radiation which is split into a beam which passes to a sample and a reference beam, the beam returning from the sample and the reference beam are variably combined and further separated into various components by means of a grating and focused onto a linear array detector. A microprocessor receives output from the array detector and performs calculations of concentration(s) of the known substance(s).

Abstract: A method and apparatus for detecting improper liquid content of a metering tip of an analyzer. The method detects the content or status using radiation between 630 and 2000 nm, and comprises the steps of: a) aspirating the liquid into the tips; b) scanning the liquid; c) providing relative motion between the tip and the scanner while simultaneously scanning the liquid; d) detecting the amount of light transmitted to detector at all levels of the liquid; e) comparing the detected light with light known to be transmitted at levels of liquid free of air bubbles; and flagging the results.

Abstract: Apparatus and method for detecting patient sample quality, and/or analytes, in the tip used to aspirate the patient sample liquid and then dispense it onto a slide test element. Spectrophotometric analysis is done on the liquid while still in the tip, by scanning the tip for transmittance in a light-tight enclosure, using NIR and adjacent visible radiation, and detecting the absorbance spectra of the liquid. Thereafter, or prior thereto, the liquid is dispensed onto a dried slide test element for assaying analytes that are not assayed spectrophotometrically, thus enhancing throughput.

Abstract: A method of preventing false detection of signal due to splashing of reagent liquid used to produce such signal, when dispensing at least one such liquid from a metering tip into a second liquid, comprising the steps of: a) positioning the metering tip a predetermined distance above the upper level of the second liquid prior to dispensing the one liquid; andb) while maintaining the distance throughout the dispensing of the one liquid, dispensing the one liquid;wherein the predetermined distance is between about 1.0 mm and about 2.0 mm so that splashing during dispensing is reduced.

Abstract: An apparatus and a related method for uniformly transferring a liquid material to a test slide element in which a transfer element having a liquid supporting surface area approximately equal to the surface area subtended by the test volume of the test slide element is brought into direct contact with the test element surface so that the liquid is distributed all at once thereto.

Abstract: Apparatus and method for detecting patient sample quality, and/or analytes, in the tip used to aspirate the patient sample liquid and then dispense it onto a slide test element. Spectrophotometric analysis is done on the liquid while still in the tip, by scanning the tip for transmittance in a light-tight enclosure, using NIR and adjacent visible radiation, and detecting the absorbence spectra of the liquid. Much smaller liquid volumes, and no through-the-label detection, are required, compared to doing the scanning of the liquid in a primary patient collection container.

Abstract: An improved cartridge and method of dispensing test elements therefrom, which seals off the elements from exposure to the atmosphere. The cartridge includes, at its end apertured to eject test elements, a cover plate, said plate optionally being biased into contact with the end-most test element to cover the fluid opening provided in all such test elements. To dispense that end-most element, a pusher blade engages and ejects the element as in conventional cartridges. Optionally, the opposite end of the cartridge is sealed with a duck-bill seal.

Abstract: Humidity control apparatus for articles being stored, comprising: a) a chamber within which the articles are to be contained, b) a conveyor passing by a portion of, and exposed to, the contents of the chamber, c) a drive mechanism for driving the conveyor past the portion of the chamber, d) a desiccant on the conveyor, e) a humidistat positioned to measure the water vapor content within the chamber, and f) a control mechanism operatively connecting the humidistat and the drive mechanism for advancing fresh desiccant past the chamber when the water vapor content of the chamber is too high.

Abstract: A method of separating bound labeled indicator from free labeled indicator in a layer of a test element for immunoassay. The method comprisesa) depositing sample containing a target immunoanalyte capable of binding to the labeled indicator or to an immobilized antibody in competition with the labeled indicator, onto an exterior surface of a test element in the presence of the labeled indicator andb) adding an amount of wash liquid to the exterior surface to form a pool of the liquid having a meniscus on the surface, the liquid penetrating the surface over an area bounded by a closed intersect edge formed between the pool meniscus and the surface, so that penetrating liquid can push free labeled indicator away from bound labeled indicator in a volume of the layer below the bounded area.