Methods for enhancing specificity and sensitivity of group a Streptococcus immunoassay
AssigneeAugusta SpinCo Corporation
InventorsMichael D. Fiechtner, Huimiao Ren
Life of this patent
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Abstract
The present disclosure provides methods and kits for detecting Group A Streptococcus in biological samples. More particularly, the present disclosure provides methods for enhancing the specificity and sensitivity of Group A Streptococcus immunoassays by including N-propionyl-D-glucosamine, 2-N-butanoyl-D-glucosamide, Bis-(2-(D-2-deoxy-glucosaminyl))-PEG3-amide, m-PEG4-glucosamine, m-PEG6-glucosamine, or m-PEG10-glucosamine. The methods and kits disclosed herein are thus useful for reliable and early diagnosis of streptococcal infections in a subject.
Claims15
A device for detecting the presence of Group A streptococcus in a sample, comprising:
- a matrix having
- (i) a sample receiving zone for receiving a sample containing or suspected of containing a Group A streptococcus-specific antigen,
- (ii) a labeling zone containing a detector antibody for specifically labeling the antigen as it passes there through and
- (iii) a capture zone having means for specifically binding the labeled antigen thereon, wherein the sample receiving zone, the labeling zone and the capture zone are arranged on the matrix in a liquid flow path, and
- wherein at least one of the sample receiving zone, capture zone, and the labeling zone comprise N-propionyl-D-glucosamine or Bis-(2-(D-2-deoxy-glucosaminyl))-PEG3-amide,
- wherein the detector antibody comprises a polyclonal antibody that specifically targets a Group A streptococcus-specific antigen, and
- wherein the amount of N-propionyl-D-glucosamine, or Bis-(2-(D-2-deoxy-glucosaminyl)-PEG3-amide is an amount effective to reduce a false positive signal in the presence of mucin in the sample.
Dependencies are inferred from the claim text.