# US 2019/0240654 A1 · Method and apparatus for mutli-channel urinalysis test kit with multi-factor control

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- Number: US 2019/0240654 A1
- Document ID: US20190240654A1
- Status: Published application
- Kind: A1
- Application number: 16/269,024
- Filed: 2019-02-06
- Published: 2019-08-08
- Earliest claimed: 2018-02-07
- Applicants: Spectrum Laboratories, LLC
- Inventors: James Matthew Stephens
- Web page: https://patentgrep.com/patent/US20190240654A1

## CPC

- B01L 3/502: {with fluid transport, e.g. in multi-compartment structures}
- A61B 10/007: {for taking urine samples (measuring urological functions A61B5/20; genital receptacles A61F5/451; urinals for bed-ridden persons A61G9/006)}
- B01L 1/52: {Transportable laboratories; Field kits}
- B01L 3/5023: {with a sample being transported to, and subsequently stored in an absorbent for analysis}
- A61B 2010/0009: {Testing for drug or alcohol abuse}
- B01L 2300/0663: Whole sensors
- B01L 2300/0825: Test strips
- B01L 2400/0406: capillary forces
- B01L: CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
- A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D)

## Abstract

A system and method for increasing confidence, privacy, and efficiency in obtaining in-home urinalysis results is contemplated. A negative-result control is provided in conjunction with a plurality of test cartridges designed to yield results about the test sample in several different regards (e.g., use of selected combinations of drugs and/or alcohol by the test subject, the integrity of the urine sample, the medical or physiological condition(s) of the test subject, etc.). Convenient sample test bins are included to allow for real-time and/or side-by-side comparison of the urine sample test results against a verified, negative result control.

## Claims

### Claim 1

A test kit for verifying urinalysis results with improved levels of confidence, the kit comprising:
a number of identical test devices each holding a plurality of urinalysis test strips arranged in a spaced apart array so that wicking or capillary action draws a test sample into contact with a discrete indicator disposed on or in each strip;
a negative-result control sample including multi-factors selected to mimic human urine; and
a plurality of sterilized test bins, matching the number of test devices, and each test bin has a sufficient depth to submerge the array of urinalysis test strips without having any single test strip come into contact with a sidewall of that bin; and
wherein each test device is contained within a separate protective covering prior to use and wherein the number of test devices is at least two.

### Claim 2 (depends on 1)

The test kit of claim 1 wherein the indicators are selected to be associated with any combination of two or more of the following: use of a drug within a window of at least 2 hours to 2 weeks prior to exposure of the indicator to the test sample; pregnancy; presence of glucose, ketones, nitrites, vitamin C, urobilinogen, and/or blood; pH of the test sample; and specific gravity of the test sample.

### Claim 3 (depends on 2)

The test kit of claim 2 wherein the drug is at least one selected from: nicotine, tetrahydrocannabinol, cocaine, amphetamine, methamphetamine, opioid analgesics, phencyclidine, methylenedioxymethamphetamine (MDMA), barbiturate, and benzodiazepines;

### Claim 4 (depends on 1)

The test kit of claim 1 wherein the discrete indicator on each test strip is concealed within a cartridge holder of the test device proximate to a viewing portal for said test strip.

### Claim 5 (depends on 4)

The test kit of claim 4 wherein written indicia is provided on the cartridge holder immediately proximate to at least one of the viewing portals, said indicia facilitating identification of a test result.

### Claim 6 (depends on 1)

The test kit of claim 1 wherein each test device is contained in a separate foil pouch.

### Claim 7 (depends on 6)

The test kit of claim 6 wherein a desiccant is provided within each pouch.

### Claim 8 (depends on 1)

The test kit of claim 1 wherein each test device is provided with an overcap that is selectively detached from the test device to expose a pathway for contact between the test sample and the indicators.

### Claim 9 (depends on 1)

The test kit of claim 1 wherein the multi-factor negative-result control sample includes at least one of shelf-life extenders, a surfactant, and a colorant.

### Claim 10 (depends on 1)

The test kit of claim 1 contained within a hermetically sealed package.

### Claim 11 (depends on 1)

A method of verifying urinalysis results, the method comprising:
providing the test kit of claim 1;
collecting a urine sample from a tested individual;
depositing the urine sample in a first test bin;
providing the multi-factor negative-result control to a second test bin;
contacting a first test device with the first bin to submerge a distal portion of the first device without contacting any part of the first test bin, thereby exposing the urine sample to the indicators of the first test device for a selected period of time;
contacting a second test device with the second bin to submerge a distal portion of the second device without contacting any part of the second test bin, thereby exposing the multi-factor negative result control to the indicators of the second test device for the selected period of time; and
comparing characteristics of the indicators of the first and second test devices to verify positive and/or negative results produced by the first test device.

### Claim 12 (depends on 11)

The method of claim 11 wherein the indicators are selected to reveal at least one of: use of a drug within a window of at least 2 hours to 2 weeks prior to exposure of the indicator to the urine sample; pregnancy; presence of glucose, ketones, nitrites, vitamin C, urobilinogen, and/or blood; pH of the urine sample; and specific gravity of the urine sample.

### Claim 13 (depends on 12)

The method of claim 12, wherein the indicators selected reveal use of a plurality of different drugs and pregnancy.

### Claim 14 (depends on 12)

The method of claim 12, wherein the indicators selected reveal use of a plurality of different drugs and at least one selected from: presence of glucose, ketones, nitrites, vitamin C, urobilinogen, and/or blood; pH of the urine sample; and specific gravity of the urine sample.

### Claim 15 (depends on 14)

The method of claim 14 wherein the contacting the first device with the urine sample occurs simultaneously with the contacting the second device with the multi-factor negative-result control to ensure the selected period of time is identical for each.

### Claim 16 (depends on 11)

The method of claim 11 further comprising warming the multi-factor negative-result control prior to contact with the second device.
