Reveal Q+ MAX® for Detection of Total Af latoxin in Corn, Almonds, Pistachios, Walnuts, and Peanuts

Abstract Background: The Reveal Q+ MAX for Aflatoxin is a lateral flow immunochromatographic test intended for quantitative analysis within 6 min after aqueous extraction. Objective: Work was conducted to validate the performance of the Reveal Q+ MAX for Aflatoxin method in selected corn and nut matrixes. Methods: This method was validated under the requirements of the AOAC Research Institute Performance Tested MethodSM program. Fivematrixes, including corn naturally contaminated with aflatoxin at 0, 5.2, 21.0, 51.6, 103.6, and 282 ppb as well as peanuts, pistachios, walnuts, and almonds spiked at 0, 5, 20, 50, and 300 ppb were analyzed. Results: Average percentage recoveries of the added aflatoxin from the matrixes ranged from 80.8 to 116.9%. Average LOD for all matrixes is 2 ppb and LOQ is 7 ppb. With the exceptionof sample size for almonds, robustness trials demonstrated that deliberate changes to the assay parameters minimally affected the Reveal Q+ MAX assay performance. Finally, stability results from three independently manufactured lots support Reveal Q+ MAX for Aflatoxin performance consistency and shelf-life of 18 months when stored at room temperature. Conclusions: This study appropriatelyvalidates the Performance Tested MethodSM claim forcorn and selected nut matrixes on Reveal Q+ MAX forAflatoxin, an aqueous lateral flow test kit. Highlights: Aqueous lateral flow test kit detects total aflatoxin between 80 to 120% yieldwith an LOD of 2 ppb.

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Validation of the Reveal® 3-D for Peanut Lateral Flow Test: AOAC Performance Tested MethodSM 111901

Journal of AOAC International ◽

10.1093/jaoacint/qsz041 ◽

2020 ◽

Vol 103 (4) ◽

pp. 1112-1118

Author(s):

Quynh-Nhi Le ◽

Alexis Vance ◽

Nawal Bakir ◽

Dave Almy ◽

Emily Slenk ◽

...

Keyword(s):

Cross Reactivity ◽

Management Program ◽

Lateral Flow ◽

Ammonium Compound ◽

Flow Test ◽

Test Kit ◽

Low Levels ◽

Lateral Flow Test ◽

Food Commodities ◽

Assay Interference

Abstract Background Reveal® 3-D for Peanut is an immunochromatographic, lateral flow test for qualitative detection of peanut residue in food manufacturing and food preparation settings. The test can detect low ppm levels of peanut in clean-in-place (CIP) rinses and in swabs from environmental surfaces and can serve as a tool in managing allergen risk. Objective The objective of the study was to validate the lateral flow method for detection of peanut in CIP rinses, specifically water, peroxyacetic acid/hydrogen peroxide, and quaternary ammonium compound rinses, and in swabs taken from stainless steel and plastic surfaces. Methods CIP rinses spiked with low levels of peanut were tested, as were surfaces inoculated with peanut. Specificity and assay interference were assessed in testing of food commodities with and without added peanut. Assay robustness and test kit stability and consistency testing were also performed. Results Results demonstrated that the lateral flow test can detect peanut in CIP rinses in the range of 2–4 ppm and in environmental surface swabs in the range of 3–4 µg/100 cm2. Results of specificity testing with 29 common food items showed lack of cross-reactivity, and potential assay interference only from walnut. Data from stability trials supports expiration dating for the kit of up to 23 months post-manufacture. Conclusions and Highlights The lateral flow test is a sensitive, specific, and rapid method for detection of low levels of peanut residue in CIP rinses and environmental samples and can be an important component in a comprehensive allergen risk management program.

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Synovasure ‘quick test’ is not as accurate as the laboratory-based α-defensin immunoassay

The Bone & Joint Journal ◽

10.1302/0301-620x.100b1.bjj-2017-0630.r1 ◽

2018 ◽

Vol 100-B (1) ◽

pp. 66-72 ◽

Cited By ~ 35

Author(s):

K. Suen ◽

M. Keeka ◽

R. Ailabouni ◽

P. Tran

Keyword(s):

Likelihood Ratio ◽

Sensitivity And Specificity ◽

Meta Analysis ◽

Negative Likelihood Ratio ◽

Lateral Flow ◽

Musculoskeletal Infection ◽

Flow Test ◽

Test Kit ◽

Lateral Flow Test ◽

Meta Analyses

Aims α-defensin is a biomarker which has been described as having a high degree of accuracy in the diagnosis of periprosthetic joint infection (PJI). Current meta-analyses are based on the α-defensin laboratory-based immunoassay rather than the quick on-table lateral flow test kit. This study is the first meta-analysis to compare the accuracy of the α-defensin laboratory-based immunoassay and the lateral flow test kit for the diagnosis of PJI. Materials and Methods A systematic review was performed according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. Inclusion criteria were all clinical studies where the diagnosis of PJI was uncertain. All studies selected used the Musculoskeletal Infection Society (MSIS) or modified MSIS criteria. Two independent reviewers reviewed the studies and extracted data. A meta-analysis of results was carried out: pooled sensitivity, specificity, positive and negative likelihood ratio, heterogeneity and areas under curves are reported. Results Ten studies (759 patients) were included. Of these, seven studies (640 patients) evaluated the laboratory-based α-defensin immunoassay and three (119 patients) the lateral flow test. The pooled sensitivity and specificity of the qualitative α-defensin laboratory immunoassay was 0.953 (95% confidence interval (CI) 0.87 to 0.984) and 0.965 (95% CI 0.943 to 0.979) respectively. The pooled positive likelihood ratio (PLR) and negative likelihood ratio (NLR) were 34.86 (95% CI 19.34 to 62.85) and 0.02 (95% CI 0.00 to 0.11). The pooled sensitivity and specificity of the lateral flow test were 0.774 (95% CI 0.637 to 0.870) and 0.913 (95% CI 0.828 to 0.958), respectively. The pooled PLR and NLR were 8.675 (95% CI 4.229 to 17.794) and 0.248 (95% CI 0.147 to 0.418), respectively. Conclusion The pooled sensitivity and specificity of the lateral flow test were lower than those of the α-defensin laboratory-based immunoassay test. Hence, care must be taken with interpretation of the lateral flow test when relying on its results for the intra-operative diagnosis of PJI. Cite this article: Bone Joint J 2018;100-B:66–72.

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Development of immunochromatographic lateral flow test for rapid detection of Clostridium perfringens α, β and ε toxins in clinical samples

BULGARIAN JOURNAL OF VETERINARY MEDICINE ◽

10.15547/bjvm.2019-0131 ◽

2021 ◽

Vol 24 (4) ◽

pp. 497-507

Author(s):

R Soliman ◽

M. M. Magdy ◽

A. Samir ◽

Y. A. Abdalla ◽

R. H. Sayed

Keyword(s):

Guinea Pigs ◽

Rapid Detection ◽

Polyclonal Antibodies ◽

Lateral Flow ◽

Clinical Samples ◽

Immunochromatographic Test ◽

Flow Test ◽

Faecal Samples ◽

Lateral Flow Test ◽

Sensitivity Specificity

In the present work a lateral flow immunochromatographic test (LFT) for rapid detection of Clostridium perfringens toxins types, alpha (α), beta (β) and epsilon (ε) in clinical samples was developed. C. perfringens toxins were prepared, purified and inactivated with 0.2% formalin. Polyclonal antibodies specific to C. perfringens toxins types α, β and ε toxoids were prepared in rabbits and guinea pigs. The toxoid specific polyclonal antibodies prepared in rabbits were labelled with gold chloride nanoparticles. The prepared toxin specific rabbit and guinea pigs antibodies and goat anti-rabbit antibodies were utilised in development of a lateral flow immunochromatographic test and the latter - evaluated for detection of C. perfringens α, β and ε toxins in clinical samples. The sensitivity and specificity and accuracy of the developed LFT were determined by comparison with a commercially available ELISA used for detection of these toxins. The prepared LFT was capable to detect C. perfringens α, β and ε toxins in quantities of 2 μg/ml, 250 ng/ml and 60 ng/ml, respectively. One hundred poultry suspected faecal samples was examined both with the prepared LFT and commercial ELISA to test the validity of developed LFT. The sensitivity, specificity and accuracy of the LFT for detection of C. perfringens toxins were 81%, 95.2% and 90%, respectively, for α toxin, 76.6%, 98.5% and 72%, respectively, for β toxin and 66.6%, 98.8% and 95%, respectively, for ε toxin.

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