US 9,810,704 B2
Systems and methods for multi-analysis
Elizabeth A. Holmes, Palo Alto, CA (US); Sunny Balwani, Palo Alto, CA (US); Michael Chen, Palo Alto, CA (US); John K. Frankovich, Palo Alto, CA (US); Gary Frenzel, Palo Alto, CA (US); Samartha Anekal, Palo Alto, CA (US); Adrit Lath, Palo Alto, CA (US); Alexander Loo, Palo Alto, CA (US); Chinmay Pangarkar, Palo Alto, CA (US); Joy Roy, Palo Alto, CA (US); Timothy Smith, Palo Alto, CA (US); and Daniel Young, Palo Alto, CA (US)
Assigned to Theranos, Inc., Palo Alto, CA (US)
Filed by Theranos, Inc., Palo Alto, CA (US)
Filed on Feb. 18, 2014, as Appl. No. 14/183,500.
Claims priority of provisional application 61/766,113, filed on Feb. 18, 2013.
Claims priority of provisional application 61/766,119, filed on Feb. 18, 2013.
Prior Publication US 2014/0296089 A1, Oct. 2, 2014
Int. Cl. C40B 30/04 (2006.01); G01N 35/00 (2006.01); G01N 35/02 (2006.01); G01N 35/04 (2006.01); G01N 35/10 (2006.01); B01L 7/00 (2006.01); C12Q 1/68 (2006.01); C12Q 1/70 (2006.01); G01N 33/569 (2006.01); G01N 33/80 (2006.01); G01N 21/25 (2006.01); B01L 9/06 (2006.01); G01N 33/543 (2006.01); B01L 3/02 (2006.01); B01L 3/00 (2006.01); G01N 21/27 (2006.01); C12Q 1/42 (2006.01); C12Q 1/52 (2006.01); G01N 33/62 (2006.01); G01N 33/68 (2006.01); G01N 33/92 (2006.01); B01L 9/00 (2006.01); G01N 15/00 (2006.01); G01N 15/14 (2006.01); G01N 15/10 (2006.01)
CPC G01N 35/0092 (2013.01) [B01L 3/021 (2013.01); B01L 3/5082 (2013.01); B01L 7/52 (2013.01); B01L 9/06 (2013.01); B01L 9/543 (2013.01); C12Q 1/42 (2013.01); C12Q 1/52 (2013.01); C12Q 1/6883 (2013.01); C12Q 1/70 (2013.01); G01N 15/1475 (2013.01); G01N 21/25 (2013.01); G01N 21/27 (2013.01); G01N 33/54306 (2013.01); G01N 33/54313 (2013.01); G01N 33/54366 (2013.01); G01N 33/56983 (2013.01); G01N 33/62 (2013.01); G01N 33/6827 (2013.01); G01N 33/80 (2013.01); G01N 33/92 (2013.01); G01N 35/00029 (2013.01); G01N 35/00069 (2013.01); G01N 35/00623 (2013.01); G01N 35/00871 (2013.01); G01N 35/026 (2013.01); G01N 35/04 (2013.01); G01N 35/10 (2013.01); G01N 35/1009 (2013.01); G01N 35/1011 (2013.01); G01N 35/1065 (2013.01); G01N 35/1072 (2013.01); B01L 9/52 (2013.01); B01L 2300/1827 (2013.01); B01L 2300/1855 (2013.01); G01N 2015/008 (2013.01); G01N 2015/0073 (2013.01); G01N 2015/1006 (2013.01); G01N 2015/1486 (2013.01); G01N 2035/00138 (2013.01); G01N 2035/00148 (2013.01); G01N 2035/00237 (2013.01); G01N 2035/00306 (2013.01); G01N 2035/00326 (2013.01); G01N 2035/00356 (2013.01); G01N 2035/00366 (2013.01); G01N 2035/00425 (2013.01); G01N 2035/00435 (2013.01); G01N 2035/00495 (2013.01); G01N 2035/00633 (2013.01); G01N 2035/0449 (2013.01); G01N 2035/0474 (2013.01); G01N 2035/0486 (2013.01); G01N 2035/0491 (2013.01); G01N 2035/0493 (2013.01); G01N 2035/0494 (2013.01); G01N 2201/024 (2013.01); G01N 2201/04 (2013.01); G01N 2201/12 (2013.01); Y10T 436/111666 (2015.01); Y10T 436/113332 (2015.01)] 17 Claims
OG exemplary drawing
 
9. A method for performing multiple assays with a biological sample, the method comprising:
providing a point-of-service, benchtop biological sample processing device
comprising a housing containing therein:
an automated sample handling system comprising a fluid handling apparatus comprising a pipette having a nozzle configured to: a) engage and hold a pipette tip and b) to engage and hold a microscopy cuvette, wherein said microscopy cuvette is configured to engage said pipette nozzle;
a first detection station comprising an electronic optical sensor;
a second detection station comprising a light source and an electronic optical sensor;
a cytometry station comprising an imaging device and a stage for receiving said microscopy cuvette; and a cartridge, wherein the cartridge is insertable into and removable from the biological sample processing device, and wherein the cartridge contains i) a biological sample, ii) at least a first, a second, and a third fluidically isolated assay unit, and iii) all reagents that are required to perform a first, second, and third assay comprising A) at least one luminescence assay; B) at least one absorbance, turbidimetric, fluorescence, or colorimetric assay; and C) at least one cytometry assay, and wherein the first assay unit is configured to perform a luminescence assay, the second assay unit is configured to perform an absorbance, turbidimetric, fluorescence, or colorimetric assay, the third assay unit is configured to perform a cytometry assay, and
transferring, by the fluid handling apparatus of the automated sample handling system, said microscopy cuvette to said stage of said cytometry station;
transferring by the automated sample handling system at least a portion of the biological sample to each of the first, second, and third assay units;
transferring by the automated sample handling system the first assay unit containing biological sample to the first detection station;
transferring by the automated sample handling system the second assay unit containing biological sample to the second detection station;
transferring by the automated sample handling system the third assay unit containing biological sample to the cytometry station, wherein said third assay unit comprises said microscopy cuvette configured to perform a cytometry assay, said microscopy cuvette having at least one cavity configured to accept a sample, and having at least one pick-up interface configured to engage with said fluid handling apparatus, said transferring comprising said pipette nozzle engaging and holding said pick-up interface of said microscopy cuvette and moving said microscopy cuvette by said pipette while said microscopy cuvette is held by said pipette nozzle; and
transferring from the cartridge to the first, second, and third assay units, respectively, all reagents required for the performance of the first, second, and third assays to the respective assay units;
wherein the sample processing device also contains a centrifuge;
a convective flow unit to provide thermally conditioned airflow to maintain a desired air temperature range in the housing;
one or more temperature sensors to provide feedback to a controller to adjust air temperature;
a fan for exhausting air flow through a filtered outlet on the housing.