Becton Dickinson and Company Limited

Laurence Michael Vaughan

Ammon David Lentz

Kevin Bailey

Joel Daniel Krayer

Sha-Sha Wang

Michael Porter

Dustin Diemert

Elaine Rose

Feng Yang

A method for penetrating a pierceable cap () on a vessel (). The pierceable cap () prevents escape of sample specimens from the vessel () before transfer with a transfer device (). The pierceable cap () may fit over a vessel (). An access port in the shell of the pierceable cap () may allow passage of a transfer device () through the pierceable cap (). At least one frangible layer () may be configured with cross slits () in a particular cross slit geometry. The cross slits () may contain an openable portion () or be covered by a thin membrane (). The shell () and frangible layer(s) () may be integrated into a one piece cap (), or be separate components (). The membrane on which the cross slitsare placed can be flat or contoured to guide the transfer device () to the cross slits (). The flat surfaces are supported by rib structures () that extend radially inward and downward into the vessel ().

Pierceable cap

A direct chemical lysis composition includes an assay compatible buffer composition and an assay compatible surfactant. When combined with a specimen storage composition, such compositions prevent undesired modifications to nucleic acid and proteins lysed from cells in the biological sample. Assays of samples from such compositions do not require expensive and time-consuming steps such as centrifugation and prolonged high temperature processing. The direct chemical lysis composition of the present invention permits direct nucleic acid extraction from the cells in the biological sample without the need to decant off the transport media or otherwise exchange the transport media with assay compatible buffers. There is no need to combine the sample with proteinase K or another enzyme to extract nucleic acids from the cells. A method for lysing cells to obtain target nucleic acid for assay and a kit for combining the direct chemical lysis composition with a sample are also contemplated.

Methods and compositions for direct chemical lysis

A pierceable capmay be used for containing sample specimens. The pierceable capmay prevent escape of sample specimens before transfer with a transfer device. The pierceable capmay fit over a vessel. An access port in the shell of the pierceable capmay allow passage of a transfer devicethrough the pierceable cap. At least one frangible layermay be configured with cross slitsin a particular cross slit geometry. The cross slitsmay contain an openable portionor be covered by a thin membrane. The shelland frangible layer(s)may be integrated into a one piece cap, or be separate components. The membrane on which the cross slitsare placed can be flat or contoured to guide the transfer deviceto the cross slits

A pierceable capmay be used for containing sample specimens. The pierceable capmay prevent escape of sample specimens before transfer with a transfer device. The pierceable capmay fit over a vessel. An access port in the shell of the pierceable capmay allow passage of a transfer devicethrough the pierceable cap. At least one frangible layermay be configured with cross slitsin a particular cross slit geometry. The cross slitsmay contain an openable portionor be covered by a thin membrane. The shelland frangible layer (s)may be integrated into a one piece cap, or be separate components. The membrane on which the cross slitsare placed can be flat or contoured to guide the transfer deviceto the cross slits

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Cockeysville, MD, United States of America

Laurence Michael Vaughan