Cross-Reactivity Sample Clauses

Cross-Reactivity. Test Description Cross-reactivity was evaluated by in silico analysis against normal flora or pathogens that cause similar symptoms or pathogens related to SARS-CoV-2. Primer-probe-sets not exceeding 80 % identity to a potential cross-reacting sequence are not predicted to cause a cross-reaction. In addition to in silico analysis, the GSD NovaPrime® SARS-CoV-2 (COVID-19) assay was performed on nucleic acid from respiratory pathogens including the human coronaviruses 229E, NL63, OC43, and SARS. All these pathogens tested by the GSD NovaPrime® SARS-CoV-2 (COVID-19) assay did not generate detectable amplification signals. A number of individual primers or probes had > 80 % identity, however, potential cross-reactivity was not identified in full primer/probe sets so detection is not predicted. To confirm this conclusion, amplification of these pathogens with the SARS-CoV-2 assay was performed to assess cross-reactivity empirically with results shown in Table 4: Measurement results with potential cross-reactive nucleic acid sequences. Additionally, the common respiratory coronaviruses 229E, NL63, and OC43 and DNA templates corresponding to the N gene sequence of SARS (position 29034 – 29233 and 28669 – 28868 of NC_004718.3) were tested empirically. Results All pathogens tested by the GSD NovaPrime® SARS-CoV-2 (COVID-19) RT-PCR kit assay did not generate detectable amplification signals. Table 4: Measurement results with potential cross-reactive nucleic acid sequences Pathogen Concentration SARS-CoV-2 [Ct] EC [Ct] Coronavirus 229E 1x104.10 TCID50/mL N.D.2 29.47 Coronavirus NL63 1x103.75 TCID50/mL N.D. 30.39 Coronavirus OC43 1x104.10 TCID50/mL N.D. 28.83 SARS NC_004718 5x104 copies/mL N.D. N.A. Parainfluenza virus 1 1x104 PFU/mL N.D. 29.56 Enterovirus 5x104 copies/mL N.D. 30.07 Rhinovirus 1x104 PFU/mL N.D. 29.80 Haemophilus influenzae 5x104 CFU/mL N.D. 29.61 Legionella pneumophila 5x104 CFU/mL N.D. 29.71 Mycobacterium tuberculosis 5x104 GEq/mL N.D. N.A.3 Streptococcus pneumoniae 5x104 CFU/mL N.D. 32.70 Streptococcus pyogenes 5x104 CFU/mL N.D. 29.82 Pseudomonas aeruginosa 5x104 CFU/mL N.D. 29.67 Streptococcus salivarius 5x104 CFU/mL N.D. 29.77 Pooled human nasal wash N.A.1 N.D. 30.57 Pooled human NP swab (UTM) N.A. N.D. 32.17 Pooled human BAL N.A. N.D. 32.02 1Not applicable 2Not detected 3Obtained as a genomic DNA sample therefore extraction was not performed Conclusion Cross reactions with nucleic acid sequences of other respiratory pathogens could not be detecte...
Sample 1
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Cross-Reactivity. BGM Galectin-3 displayed no significant cross-reactivity when tested in the presence of the following compounds: xxxxxxxx-0, xxxxxxxx-0, xxxxxxxx-0, xxxxxxxx-0, xxxxxxxx-0, xxxxxxxx-0, galectin-12, collagen I and collagen III, all at a concentration of 500 ng/mL. The mean % cross-reactivity of the above potential cross-reactants is at or below 0.3%. BG Medicine, Inc., 000X Xxxxxxx Xxxxxx, Xxxxxxx, XX 00000 Document: LAB-IVD-001 R07 Tel: (+0) 000.000.0000, Fax: (+0) 000.000.0000 Effective: 09Mar11 Portions of this Exhibit, indicated by the xxxx “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
Sample 1

Related to Cross-Reactivity

  • Illegal Activity No portion of the Property has been or will be purchased with proceeds of any illegal activity.

  • Monitoring System In each case in which the Custodian has exercised delegated authority to place Assets with a Foreign Custodian, the Custodian shall establish a system, to re-assess or re-evaluate selected Foreign Custodians, at least annually in accordance with Rule 17f-5(c)(3).

  • Controlled Substances Has current controlled substances registrations issued by the State of Colorado and the U.S. Drug Enforcement Administration, which registrations have not been surrendered, suspended, revoked or restricted in any manner;

  • Quality Control A. Controlled Affiliate agrees to use the Licensed Marks and Name only in connection with the licensed services and further agrees to be bound by the conditions regarding quality control shown in attached Exhibit A as they may be amended by BCBSA from time-to-time.

  • Pest Control A. Whenever a department utilizes a pest control chemical in State owned or managed buildings/grounds, the department will provide at least forty-eight (48) hours notice prior to application of the chemical, unless an infestation occurs which requires immediate action. Notices will be posted in the lobby of the building and will be disseminated to building tenant contacts.

  • Force Majeure Event 16.1 If a Force Majeure Event gives rise to a failure or delay in either party performing any obligation under this Agreement (other than any obligation to make a payment), that obligation will be suspended for the duration of the Force Majeure Event.

  • Control Areas Tenant shall be allowed to utilize up to its pro rata share of the Hazardous Materials inventory within any control area or zone (located within the Premises), as designated by the applicable building code, for chemical use or storage. As used in the preceding sentence, Tenant’s pro rata share of any control areas or zones located within the Premises shall be determined based on the rentable square footage that Tenant leases within the applicable control area or zone. For purposes of example only, if a control area or zone contains 10,000 rentable square feet and 2,000 rentable square feet of a tenant’s premises are located within such control area or zone (while such premises as a whole contains 5,000 rentable square feet), the applicable tenant’s pro rata share of such control area would be 20%.

  • No Control of the Other Party’s Business The Parties acknowledge and agree that the restrictions set forth in this Agreement are not intended to give Parent or Merger Sub, on the one hand, or the Company, on the other hand, directly or indirectly, the right to control or direct the business or operations of the other at any time prior to the Effective Time. Prior to the Effective Time, each of Parent and the Company will exercise, consistent with the terms, conditions and restrictions of this Agreement, complete control and supervision over their own business and operations.

  • Quality All products will be new and unused. All products provided by the Contractor must meet all federal, state, and local standards for quality and safety requirements. Products not meeting the requirements of this section will be deemed unacceptable and returned to the Contractor for credit at no charge to the State.

  • Stability 14.01 Maintain a documented, ongoing stability program to monitor the stability of the Product using stability indicating procedures. X 14.02 Data analysis and trending reporting will be performed. X

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