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US-12622599-B2 - Sample collection methods and apparatus for viral load level diagnosis

US12622599B2US 12622599 B2US12622599 B2US 12622599B2US-12622599-B2

Abstract

Provided herein are apparatuses, systems, kits, and methods, for detecting a virus contained within human breath or ambient air. The apparatus includes a housing comprising a base and a cover, the base having a sample collection surface, and the cover having a port and substantially enclosing the sample collection surface thereby defining a sample collection chamber. The apparatus includes a tube extending through the port and configured to receive a gaseous sample containing moisture and direct the gaseous sample to the sample collection surface. The apparatus includes a cooling device configured to cool the gaseous sample and thereby condense the moisture on the sample collection surface and a sample collection material disposed on the sample collection surface. The sample collection material is configured to absorb the condensed moisture.

Inventors

  • Ali AlShehri
  • Hossein Kavehpour

Assignees

  • THE REGENTS OF THE UNIVERSITY OF CALIFORNIA

Dates

Publication Date
20260512
Application Date
20221014

Claims (12)

  1. 1 . An apparatus comprising: a housing comprising a base and a cover, the base having a sample collection surface, the cover having a port and at least one vent disposed on each side of the cover, the cover substantially enclosing the sample collection surface thereby defining a sample collection chamber; a tube extending from a proximal end to a distal end, the proximal end having a proximal opening and the distal end having a distal opening, the tube extending through the port such that the distal opening is in fluid communication with the sample collection chamber, wherein the proximal opening is configured to receive a gaseous sample containing moisture and direct the gaseous sample to the sample collection surface; a cooling device configured to cool the sample collection surface and thereby condense at least a portion of the moisture on the sample collection surface; and a sample collection material disposed on the sample collection surface, the sample collection material configured to absorb the condensed moisture.
  2. 2 . The apparatus of claim 1 , wherein each vent comprises a cutout along a bottom surface of the cover, wherein at least a portion of the bottom surface is configured to contact the sample collection surface.
  3. 3 . The apparatus of claim 1 , wherein the sample collection material comprises a ring, wherein the ring is positioned on the sample collection surface such that the tube is directed at a center of the ring.
  4. 4 . The apparatus of claim 1 , wherein the sample collection surface comprises a slot, wherein the slot comprises a depth that is less than a thickness of the base and wherein the base comprises a first length and the slot comprises a second length, wherein the second length is less than the first length.
  5. 5 . The apparatus of claim 4 , wherein the sample collection material is disposed in the slot.
  6. 6 . The apparatus of claim 1 , wherein the sample collection surface comprises a hydrophobic treatment, wherein the hydrophobic treatment comprises a hydrophobic silicon polymer.
  7. 7 . The apparatus of claim 1 , wherein the tube is removable from the port.
  8. 8 . The apparatus of claim 1 , wherein the cooling device comprises a thermoelectric device, wherein the cooling device is thermally coupled to the sample collection surface and wherein the cooling device is configured to cool the sample collection surface to between about 5° C. and about 22° C.
  9. 9 . The apparatus of claim 1 , wherein the sample collection surface comprises a receptor to a coat protein of a virus.
  10. 10 . The apparatus of claim 1 , wherein the sample collection material comprises a wicking material and one or more antibodies.
  11. 11 . The apparatus of claim 1 , wherein the sample collection surface comprises one or more antibodies.
  12. 12 . The apparatus of claim 1 , wherein a height between the distal end of the tube and the sample collection surface is about 1.5 mm to about 52.5 mm and wherein a diameter of the tube is about 2 mm to about 3 mm.

Description

CROSS-REFERENCE TO RELATED APPLICATION This application is a Continuation of International Application PCT/US21/27456, filed on Apr. 15, 2021, which claims the benefit of U.S. Provisional Patent Application No. 63/010,453, filed on Apr. 15, 2020. Each of these applications are hereby incorporated by reference in its entirety. NOTICE OF MATERIAL SUBJECT TO COPYRIGHT PROTECTION A portion of the material in this patent document is subject to copyright protection under the copyright laws of the United States and of other countries. The owner of the copyright rights has no objection to the facsimile reproduction by anyone of the patent document or the patent disclosure, as it appears in the United States Patent and Trademark Office publicly available file or records, but otherwise reserves all copyright rights whatsoever. The copyright owner does not hereby waive any of its rights to have this patent document maintained in secrecy, including without limitation its rights pursuant to 37 C.F.R. § 1.14. BACKGROUND The rapid spread and virulence of COVID-19 has exposed a critical need for both individual patient point of care and environmental sampling and testing. To protect society from the current wave of illnesses and the potential second (possibly deadlier wave), efficient sampling and rapid testing should be deployed into critical infrastructure including food processing plants, hospitals, dental offices, essential government offices, airports, etc. The following is a list of qualities of a testing system for a viral pathogen: (a) the test system should provide fast, efficient patient testing taking samples directly from the lungs where the virus is most abundant; (b) the test system should provide a non-invasive test since the high-volume testing will involve children, senior citizens, mental health patients, and many others who cannot tolerate swab tests; (c) swab tests are known to cause secondary infection for high percentage of the sampling cases. (d) the gold standard outcome of testing would be monitoring for both virus and antibodies on the same sampling; (e) health care providers need a way to monitor viral load in lungs directly to better understand when patients are no longer contagious to quickly gauge the efficacy of different treatments; (f) a system is needed for environmental monitoring to determine contamination in rooms and surfaces by continuously sampling the air and the aerosols that settle onto counters, floors and other horizontal surfaces; (g) a system is needed for providing data to understand amount of virus in exhaled breath to better understand necessary distancing and danger of infection in the absence of coughs and sneezes. Current patient sampling is performed by deep nasal swabbing and there is no known system capable of sampling the environment for COVID-19. It has been shown that viruses can be retrieved from the exhaled breath, by analyzing HEPA filters described in “Influenza virus in human exhaled breath: an observational study” by Fabian, et al. Additionally, it has been shown that viruses can be retrieved from the exhaled breath, by analyzing an Exhaled Breath Condensation (EBC) technique described in “Infectious virus in exhaled breath of symptomatic seasonal influenza cases from a college community” by Yan, et al. Existing EBC may take 30 minutes to an hour of breathing through a tube in order to collect sufficient samples as described in “Exhaled breath condensate: methodological recommendations and unresolved questions.” by Horvath et al. BRIEF SUMMARY In various embodiments, an apparatus includes a housing comprising a base and a cover. The base has a sample collection surface and the cover has a port and substantially encloses the sample collection surface thereby defining a sample collection chamber. The apparatus further includes a tube extending from a proximal end to a distal end, where the proximal end has a proximal opening and the distal end has a distal opening, and the tube extends through the port such that the distal opening is in fluid communication with the sample collection chamber. The proximal opening is configured to receive a gaseous sample containing moisture and direct the gaseous sample to the sample collection surface. The apparatus further includes a cooling device configured to cool the sample collection surface and thereby condense at least a portion of the moisture on the sample collection surface. The apparatus further includes a sample collection material disposed on the sample collection surface, and the sample collection material is configured to absorb the condensed moisture. In various embodiments, a method for detecting a virus contained within breath of a human is provided where a gaseous sample of human breath containing moisture at a sample collection surface is received. The sample collection surface is cooled to a temperature lower than the dew point of the moisture in the gaseous sample thereby condensing the moisture on the sa