METHOD AND SYSTEM FOR TESTING BLOOD SAMPLES

Systems, processes and devices are provided which are useful for testing blood or plasma donations to detect those specific donations which are contaminated by virus above a predetermined level. An apparatus and process is described which form individual, spearately sealed, and connected sample-cont...

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Hauptverfasser: WHALEN, JOHN, J, CHLEBOWSKI, MICHAEL, E, HELDEBRANT, CHARLES, M, MATVELD, H., EDWARD
Format: Patent
Sprache:eng ; fre
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Zusammenfassung:Systems, processes and devices are provided which are useful for testing blood or plasma donations to detect those specific donations which are contaminated by virus above a predetermined level. An apparatus and process is described which form individual, spearately sealed, and connected sample-containing pouches from a flexible hollow tubing segment connected to a fluid donation container. The tubing segment is sealed at spaced-apart intervals along its length, with tubing segment portions in the intervals between the seals defining pouches, each of which contains a portion of a plasma sample. The contents of the pouches are formed into pools which are subsequently tested for virus contamination by a high sensitivity test such as PCR. When a pool tests positive, indicating it is contaminated by a virus, a further pouch is removed from each of the tubing segments used to form the initial pool. Subsequent pouches are divided into approximately equal sized subgroups and their contents separately formed into subpools. A selected one of the subgroup pools is then tested for virus contamination. The test process is iterated, with each pool that tests positive being further subdivided into two successively smaller subgroups, until two final subgroups are formed, each comprising a single pouch corresponding to a single plasma donation. The final two pouches are subsequently PCR tested in order to determine and uniquely identify the corresponding contaminated donation. Cette invention concerne des systèmes, des procédés et des dispositifs utiles pour tester des dons de sang ou de plasma pour détecter de manière spécifique les dons qui sont contaminés par un virus au-delà d'un niveau prédéterminé. On décrit un procédé et un appareil dans lequel on forme à partir d'une longueur de tube creux et souple, reliée à un récipient de collecte des dons de sang ou de plasma de petites poches individuelles, fermées séparément, reliées entre elles et contenant les échantillons. La longueur de tube est scellée sur sa longueur à des intervalles espacés, les parties de longueur de tube situées dans les intervalles entre les soudures définissant des petites poches qui contiennent chacune une partie d'un échantillon de plasma. Les contenus de ces pochees sont groupés en lots qui sont ensuitr testés pour rechercher la contamination virale à l'aide d'un test extrêmement sensible tel que le test de réaction en chaîne de la polymérase (test PCR). Lorsqu'un lot est détecté comme positif