other:Article Title:
Article Snippet: For ATCC 19395, all three (3) replicates gave a ‘B. pertussis NOT DETECTED’ result, demonstrating no cross-reactivity.
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Article Snippet: For B. bronchiseptica, three strains were tested: ATCC 19395, ATCC 4617, and ATCC BAA-588.
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Article Snippet: _______________________________________________________________________________________________ 5.0 510(k) Summary Page 9 of 18 For B. bronchiseptica, three strains were tested: ATCC 19395, ATCC 4617, and ATCC BAA-588 (Table 4).
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Article Snippet: For ATCC 19395, all three (3) replicates gave a ‘B. pertussis NOT DETECTED’ result, demonstrating no cross-reactivity.
In Silico:Article Title:
Article Snippet: .. B. parapertussis ATCC 15237 Bordetella Parapertussis/ bronchiseptica 7.29E+03 3x ATCC 9305 7.29E+03 3x ATCC BAA-587 7.29E+03 3x ATCC 15989 7.29E+03 3x Zeptometrix 0801461 2.19E+04 9x B. bronchiseptica ATCC 4617 Bordetella Parapertussis/ bronchiseptica 7.29E+03 3x ATCC 7773 7.29E+03 3x ATCC 785 7.29E+03 3x ATCC 14064 7.29E+03 3x ATCC 10580 7.29E+03 3x ATCC 19395 7.29E+03 3x B. holmesii Zeptometrix 0801464 B. holmesii 2.19E+04 9x ATCC 700053 2.43E+03 1x ATCC 700052 2.43E+03 1x Supplemental Adenovirus Reactivity Information (in silico analyses): In silico analysis predicts that the RP Flex will detect Adenovirus species G as the oligo sequence match to the target sequence for Adenovirus G is identical to that for Adenovirus A. f. Analytical Specificity/Cross-reactivity Evaluation: An analytical specificity study was carried out to assess the potential for false positive results due to cross-reactivity between RP Flex assays and in-panel or non-panel bacterial, viral, and fungal organisms known or expected to be present in the upper respiratory system and that may be present in NPS. ..
Sequencing:Article Title:
Article Snippet: .. B. parapertussis ATCC 15237 Bordetella Parapertussis/ bronchiseptica 7.29E+03 3x ATCC 9305 7.29E+03 3x ATCC BAA-587 7.29E+03 3x ATCC 15989 7.29E+03 3x Zeptometrix 0801461 2.19E+04 9x B. bronchiseptica ATCC 4617 Bordetella Parapertussis/ bronchiseptica 7.29E+03 3x ATCC 7773 7.29E+03 3x ATCC 785 7.29E+03 3x ATCC 14064 7.29E+03 3x ATCC 10580 7.29E+03 3x ATCC 19395 7.29E+03 3x B. holmesii Zeptometrix 0801464 B. holmesii 2.19E+04 9x ATCC 700053 2.43E+03 1x ATCC 700052 2.43E+03 1x Supplemental Adenovirus Reactivity Information (in silico analyses): In silico analysis predicts that the RP Flex will detect Adenovirus species G as the oligo sequence match to the target sequence for Adenovirus G is identical to that for Adenovirus A. f. Analytical Specificity/Cross-reactivity Evaluation: An analytical specificity study was carried out to assess the potential for false positive results due to cross-reactivity between RP Flex assays and in-panel or non-panel bacterial, viral, and fungal organisms known or expected to be present in the upper respiratory system and that may be present in NPS. ..
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