US 12,235,217 B2
Diagnostic test kits for sample preparation and analysis
Yunyuan Vivian Wang, Tustin, CA (US); Aaron Alexander Rowe, Toluca Lake, CA (US); Hui-Ling Koh, Santa Ana, CA (US); Stephen L. Chen, Tustin, CA (US); and K C Chen, Anaheim, CA (US)
Assigned to Scanwell Health, Inc., Franklin Lakes, NJ (US)
Filed by Scanwell Health, Inc., Los Angeles, CA (US)
Filed on Nov. 13, 2020, as Appl. No. 17/098,236.
Claims priority of provisional application 62/934,655, filed on Nov. 13, 2019.
Prior Publication US 2021/0231574 A1, Jul. 29, 2021
Int. Cl. G01N 21/78 (2006.01); G01N 1/34 (2006.01)
CPC G01N 21/78 (2013.01) [G01N 1/34 (2013.01)] 14 Claims
OG exemplary drawing
 
1. A kit for quantification of porphobilinogen (PBG) in a urine sample, the kit comprising:
a) diagnostic test strip comprising:
a substrate impregnated with a dried solution comprising an acid, a reagent reactive with PBG, and one or more stabilizers;
b) a pre-processing reagent comprising urease,
wherein the amount of pre-processing reagent is sufficient to remove urea such that a 2 ml urine sample contacted with pre-processing reagent for a period of 10 seconds to 15 minutes will contain an amount of urea that is undetectable by the test strip; and
c) a cation-exchange resin device comprising a vessel and a cation-exchange resin arranged in the vessel,
wherein the cation-exchange resin binds to urobilinogen at an affinity greater than it binds to PBG, such that a urine sample of 2 ml contacted with the cation-exchange resin in the vessel for a period 5 to 20 minutes will contain an amount of urobilinogen that is undetectable by the test strip but will contain an amount of PBG detectable by the test strip.