Evidence map›Paper›PMID 36130279›Full record

ArticleJournal of AOAC International2022

Soleris® Automated System for the Rapid Detection of Burkholderia cepacia Complex in Cosmetic Products.

Lei Zhang, Jerry Tolan, Nicholas Lavigne, Carolyn Montei, Robert Donofrio, Preetha Biswas

Abstract read
In one paragraph

Article in Journal of AOAC International, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

1 citing paper in PubMed.

  1. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

6 authors.

Lei ZhangMicrobiology R&D, Neogen Corporation, 620 Lesher Place, Lansing, MI 48912, USA.ORCID 0000-0002-1797-5635
Jerry TolanMicrobiology R&D, Neogen Corporation, 620 Lesher Place, Lansing, MI 48912, USA.ORCID 0000-0001-5967-8770
Nicholas LavigneMicrobiology R&D, Neogen Corporation, 620 Lesher Place, Lansing, MI 48912, USA.ORCID 0000-0003-4101-8162
Carolyn MonteiMicrobiology R&D, Neogen Corporation, 620 Lesher Place, Lansing, MI 48912, USA.ORCID 0000-0001-8312-1278
Robert DonofrioMicrobiology R&D, Neogen Corporation, 620 Lesher Place, Lansing, MI 48912, USA.
Preetha BiswasMicrobiology R&D, Neogen Corporation, 620 Lesher Place, Lansing, MI 48912, USA.ORCID 0000-0001-7425-2612

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundBurkholderia cepacia complex (Bcc) has emerged as an important opportunistic pathogen with rising concern in pharmaceuticals and cosmetic products. The Bcc supplement (S2-BCC-S) was purposely developed and used with the Pseudomonas vial (PD-109) for the detection of Bcc through the Soleris® Next Generation automated instrument system.

objectiveThis study aimed to evaluate the performance of the Soleris Bcc testing method for cosmetic products.

methodInclusivity and exclusivity were assessed with the Soleris Bcc method and the United States Pharmacopeia (USP) method in three enrichment broths. Matrix testing was conducted using 28 cosmetic products to compare the equivalency of the Soleris Bcc method to that of the USP reference method. Repeatability of the Soleris Bcc assay, method robustness, product stability, and lot-to-lot consistency of the Soleris reagents were also assessed.

resultsBoth the Soleris Bcc and the USP methods supported the growth of all 26 inclusivity strains, except the USP method missed one inclusivity strain in one broth. For exclusivity, 0-6% was presumptive positive with the Soleris Bcc method, and 42-48% was presumptive positive with the reference method. Kappa index was 0.96 for the matrix testing, indicating a good agreement between the Soleris Bcc assay and the reference method for testing Bcc in cosmetics. Repeatability results showed the coefficient of variation was less than 4%. The robustness and ruggedness study yielded detection times within 1 h differences when small variations were introduced. The lot-to-lot study showed consistent results among four lots of the Bcc reagents.

conclusionsThe automated Soleris method was successfully demonstrated to be robust, sensitive, and specific for Bcc detection in cosmetic products. HIGHLIGHTS: The Soleris Bcc method is user-friendly. It shows the results in real time and generates the report automatically. Implementation of this method for detection of Bcc in cosmetics would save significant time and resources.

Indexed as

Burkholderia cepacia complexCosmeticsIndicators and ReagentsCosmeticsIndicators and Reagents

Identifiers

PMID36130279
PMCPMC9779911

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.