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Buffer compositions for aggregation reduction

A technology of composition and buffer, which is applied in the field of buffer composition for reducing aggregation, can solve problems such as increasing the ratio of unresolved results, loss of functionalization, and reducing measurement sensitivity, so as to reduce the aggregation of surface functionalized particles Effect

Pending Publication Date: 2022-04-12
BECTON DICKINSON & CO
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Consequently, many nucleic acid-based assays not only generate more reporting errors (false positives and false negatives) but also increased unreportable results (e.g., unreportable results due to failure of internal controls) in the presence of interfering substances. analytical results, uncertain results due to excessive noise, etc.)
For example, particle aggregation leads to loss of functionalization and can thereby reduce assay sensitivity and increase the rate of unresolved results

Method used

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  • Buffer compositions for aggregation reduction
  • Buffer compositions for aggregation reduction
  • Buffer compositions for aggregation reduction

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0064] Diagnostic Assays Performed on Vaginal Samples

[0065] The studies described here in this section exemplify the detection of vaginal disorders such as vulvovaginal candidiasis (VVC), trichomoniasis, and bacterial infection in clinical vaginal swab samples that may contain interfering substances by utilizing the buffer compositions disclosed herein. Robust performance of a diagnostic assay for vaginosis (BV). For example, the assay is in the BD MAX TM Fully automated in vitro diagnostic tests were implemented on the system for the qualitative detection of Candida species (eg, C. glabrata and C. krusei), Trichomonas vaginalis and / or BV-associated bacteria. These assays incorporate microfluidics-based sample processing and nucleic acid-based detection methods. More specifically, the diagnostic assay utilizes fluid-operated magnetic particles for nucleic acid extraction, real-time polymerase chain reaction (PCR) for target DNA amplification, and fluorescent hybridization...

Embodiment 2

[0073] Test repeatability

[0074] Table 2 summarizes the agreement rate between assay results obtained in two tests ("First" and "Second") of the same sample ("Same Swab"). Comparative buffers were used in the assays of Table 2(a) and Example Buffer I was used in the assays of Table 2(b)). Tables 2(a)-2(b) list positive results, negative results, and overall for Candida species, Candida glabrata, Candida krusei, Trichomonas vaginalis, and BV (from top to bottom), respectively. (from left to right) agreement rate.

[0075] Table 2. Baseline Reproducibility of Diagnostic Assays

[0076]

[0077] Both Comparative Buffer and Example Buffer I achieved at least 90.0% between two different tests ("Field 1" and "Field 2") of the "same swab" when performing diagnostic assays for various pathogenic markers consistency.

[0078] Thus, this example provides a representative baseline for the reproducibility of diagnostic assays and related methods.

Embodiment 3

[0080] Test reproducibility

[0081] Table 3 summarizes the assays obtained during the testing ("Field 1") of one of two samples ("Swab 1" and "Swab 2"), respectively, collected from the same subject (or sample donor) The agreement rate between the results. The comparison buffer was used in the assay of Table 3(a) and the example buffer I was used in the assay of Table 3(b). Tables 3(a)-3(b) list positive results, negative results, and overall (from left) for Candida species, C. to right) agreement rate.

[0082] Both Comparative Buffer and Example Buffer I achieved at least 90.0% concordance between two different samples ("Swab 1" and "Swab 2") obtained from the same subject when tested for various pathogenic markers.

[0083] Table 3. Baseline reproducibility of PCR assays for pathogen detection

[0084]

[0085] Thus, this example demonstrates a representative baseline for the reproducibility of diagnostic assays and related methods.

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Abstract

The disclosure includes compositions, kits, and methods for detecting and identifying vaginal disorders, such as vulvovaginal candidiasis, trichomoniasis, and / or bacterial vaginosis, based on nucleic acids. The compositions, kits, and methods are useful for obtaining robust diagnostic test performance against interfering substances, such as gels present in clinical vaginal swab samples.

Description

[0001] Cross References to Related Applications [0002] This application claims priority to U.S. Provisional Patent Application Serial No. 62 / 879,310, filed July 26, 2019, which is hereby incorporated by reference in its entirety. technical field [0003] The present disclosure relates to compositions, kits and methods including, for example, buffer compositions, assay kits comprising the same, uses thereof and diagnostic test methods for vaginal disorders or / and sexually transmitted diseases associated therewith. In some embodiments, the compositions, kits and methods enable robust high performance diagnostic tests from biological samples, especially in the presence of interfering substances. Some embodiments relate to the use of the compositions, kits and methods disclosed herein against vulvovaginal candidiasis-associated Candida species, Trichomonas vaginalis causing trichomoniasis, from clinical vaginal swabs. vaginalis) and / or bacteria associated with bacterial vaginos...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): C12N15/10C12Q1/6806C12Q1/689G01N1/28G01N1/34
CPCC12Q1/6806C12Q1/689C12Q2527/125C12Q2527/137C12Q1/6893C12N15/10
Inventor J-S·科特M-C·福廷V·布兰切特M-H·特伦布雷S·莫拉斯S·盖伊S·赛玛德
Owner BECTON DICKINSON & CO
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