Method and apparatus for microorganism detection

Patent metadata

Field	Value
Publication number	US-11318459-B2
Application number	US-201314426555-A
Country	US
Kind code	B2
Filing date	Sep 4, 2013
Priority date	Sep 7, 2012
Publication date	May 3, 2022
Grant date	May 3, 2022

Abstract

A method for detecting the presence of a microorganism in a fluid sample is disclosed. The method includes providing a fluid specimen within a specimen collection container having a sidewall defining an interior therein. The interior includes a mechanical separator adapted for separating the fluid sample into first and second phases within the specimen collection container and a sensing element capable of detecting the presence of a microorganism disposed therein. The method includes subjecting the specimen collection container to applied rotational force to isolate a concentrated microorganism region. The method also includes detecting by a sensing element the presence or absence of a microorganism within the concentrated microorganism region.

First claim

The invention claimed is:

1. An apparatus for detecting the presence of a microorganism, comprising:
a specimen collection container comprising an open top end, a bottom end, and a sidewall extending therebetween defining an interior therein;
a closure engageable with the specimen collection container to seal the open top end;
a mechanical separator disposed within the interior and adapted for separating a fluid sample into first and second phases within the specimen collection container, the mechanical separator having at least one feature selected from the group consisting of at least two regions of differing densities and a density gradient; and
a sensor device disposed within the interior of the specimen collection container and capable of detecting the presence of a microorganism present within the interior of the specimen collection container.

2. The apparatus of claim 1 , wherein the mechanical separator is radially deformable between a first position in which the fluid sample can pass between an inner surface of the sidewall of the specimen collection container and the mechanical separator, and a second position in which at least a portion of the mechanical separator circumferentially contacts the inner surface of the sidewall preventing the fluid sample from passing between the inner surface of the sidewall of the collection container and the mechanical separator.

3. The apparatus of claim 1 , wherein the mechanical separator comprises:
a deformable bellows having an upper end and a lower end, and a sealing portion disposed therebetween providing sealing engagement with the sidewall of the specimen collection container;
a float, having a first density, engaged with a portion of the bellows; and
a ballast, having a second density, the second density being greater than the first density, engaged with a portion of the bellows.

4. The apparatus of claim 1 , wherein the mechanical separator comprises a separator body having a through-hole defined therein, the through-hole adapted for allowing fluid to pass therethrough, the separator body comprising a float, having a first density, and a ballast, having a second density greater than the first density, wherein a portion of the float is connected to a portion of the ballast.

5. The apparatus of claim 4 , wherein the mechanical separator is releasably engaged with a portion of the closure.

6. The apparatus of claim 4 , wherein the mechanical separator is engaged with a portion of the closure in a first initial position, and wherein the mechanical separator is engaged with a portion of the sidewall of the specimen collection container in a second sealing position.

7. The apparatus of claim 1 , wherein the fluid specimen is blood, and the first phase comprises lower density blood constituents, and the second phase comprises microorganisms.

8. The apparatus of claim 1 , wherein the sensor comprises one or more electronic, electrochemical, thermal, impedance, capacitance, redox, and/or turbidity mechanisms for detecting at least one of metabolic energy, carbon dioxide, pH, and volatile organic compounds.

9. The apparatus of claim 1 , wherein the sensor device is a solid-state optical sensor.

10. The apparatus of claim 1 , wherein the second phase is denser than the first phase and the sensor is provided in communication with the second phase.

11. The apparatus of claim 1 , further comprising a lysis reagent disposed within the interior of the specimen collection container.

12. The apparatus of claim 1 , wherein a volume of fluid of the second phase is from about 1 μl to about 500 μl.

13. The apparatus of claim 1 , wherein a volume of fluid of the second phase is from about 5 μl to about 200 μl.

14. The apparatus of claim 1 , wherein the bottom end is open and a second closure is engageable with the open bottom end to seal the open bottom end.

15. The apparatus of claim 1 , wherein the apparatus further comprises microorganism growth media co-formed with the electronic sensor.

16. An apparatus for detecting the presence of a microorganism, comprising:
a specimen collection container comprising an open top end, a bottom end, and a sidewall extending therebetween defining an interior therein;
a closure engageable with the specimen collection container to seal the open top end;
a mechanical separator disposed within the interior and adapted for separating a fluid specimen into first and second phases within the specimen collection container, the mechanical separator comprising a one-way valve and isolating a first chamber portion of the interior from a second chamber portion of the interior,
wherein the one-way valve is transitionable from a closed position, in which the first chamber portion is in fluid isolation from the second chamber portion, to an open position, in which a portion of the fluid specimen may pass through the one-way valve from the first chamber portion to the second chamber portion; and
an electronic sensor disposed within the interior of the specimen collection container, comprising one or more electronic, electrochemical, thermal, impedance, capacitance, redox, and/or turbidity mechanisms, and capable of detecting the presence of a microorganism within the interior of the specimen collection container.

17. The apparatus of claim 16 , wherein the one-way valve is transitionable from the closed position to the open position upon application of an applied rotational force.

18. The apparatus of claim 17 , wherein the one-way valve is subsequently transitionable from the open position to the closed position upon cessation of the applied rotational force.

19. The apparatus of claim 16 , wherein the sensor is provided in communication with the second chamber portion.

20. The apparatus of claim 16 , wherein a volume of fluid of the second chamber portion is from about 1 μl to about 500 μl.

21. The apparatus of claim 16 , wherein a volume of fluid of the second chamber portion is from about 5 μl to about 200 μl.

22. The apparatus of claim 16 , wherein the electronic sensor is a sensor for detecting at least one of metabolic energy, carbon dioxide, pH, and volatile organic compounds.

23. The apparatus of claim 16 , further comprising a lysis reagent disposed within the interior of the specimen collection container.

24. An apparatus for detecting the presence of a microorganism, comprising:
a specimen collection container comprising an open top end, a bottom end, and a sidewall extending therebetween defining an interior therein, the interior comprising a lysis reagent disposed therein;
a closure engageable with the specimen collection container to seal the open top end;
a mechanical separator disposed within the interior and adapted for separating a fluid sample into first and second phases within the specimen collection container, the mechanical separator having at least one feature selected from the group consisting of at least two regions of differing densities, a density gradient, and a one-way valve and isolating a first chamber portion of the interior from a second chamber portion of the interior, wherein the one-way valve is transitionable from a closed position, in which the first chamber portion is in fluid isolation from the second chamber portion, to an open position, in which a portion of the fluid specimen may pass through the one-way valve from the first chamber portion to the second chamber portion; and
a solid-state sensor disposed within the interior of the

Assignees

• Becton Dickinson Co

Inventors

• Shi Song
• Yang Mei
• Berndt Klaus W
• Losada Robert J
• Crawford Jamieson W
• Attri Ravi
• Battles Christopher A
• Bartfeld Benjamin R
• Hires Gregory R

Classifications

• B01L3/50215 Primary

  using a float to separate phases · CPC title

• G01N1/40

  Concentrating samples · CPC title

• B01L2300/06

  Auxiliary integrated devices, integrated components · CPC title

• B01L2300/0663

  Whole sensors · CPC title

• B01L3/5082

  Test tubes per se · CPC title