Rapid Molecular RT-LAMP Test Reagents (96 Test Samples)

  • $4,224.00
    Unit price per 
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Test Overview

  • Rapid Molecular Testing (RT-LAMP)
  • Results in under 30 minutes
  • FDA Emergency Use Authorization for Moderate to High Complexity CLIA Settings
  • Diagnostic Results
    • Positive Percent Agreement: 97.7%
    • Negative Percent Agreement: 100%

 

Product Documentation

FDA Emergency Use Authorization LetterInstructions For UseGraphic Instructions for Use | Sample Results Report

 

Test Kit Includes

Each kit includes enough reagents / materials to run 96 samples.

  • 12 MD-Bio PCR Strips (the provided PCR strips have been validated with this assay)
  • 1 MD-Bio Preparation Station
  • 1 1.25mL vial of BCC19 Reagent 1
  • 1 1.2mL vial of BCC19 Reagent 2
  • 1 MD-Bio Analysis Station
  • 1 100uL vial of BCC19 Positive Control
    • Positive Control for this assay is diluted to 375 copies/μL (5X LoD) from Twist Bioscience, Synthetic SARS-CoV-2 RNA Control 1 (MT007544.1)) PN: 102019
  • 96 VTM or Saline Solution Tubes
  • 96 Nasopharyngeal Swabs

 

Optional Materials Required

    Thermal Cycling Device

       

       

      RT-LAMP vs. RT-PCR

      RT-LAMP
      RT-PCR
       30 Minute Result
      4-8 Hour Result
      1-2 Technicians Required
      5-7 Technicians Required
      Small and Portable
      Large, not portable
      Detects DNA and RNA
      Detects DNA
      Single Heat Block
      Specialized Thermal Cyclers
       
       

       

      Intended Use

      The Bio BCC19 Test Kit is a reverse transcriptase loop-mediated isothermal amplification (RT-LAMP) test intended for the qualitative detection of RNA from the SARS-CoV-2 in nasopharyngeal (NP), oropharyngeal (OP), mid-turbinate (MT) and anterior nares (nasal) swab specimens from individuals suspected of COVID-19 by their healthcare provider. Testing is limited to laboratories - certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, that meet the requirements to perform high or moderate complexity tests

      Results are for the identification of SARS-CoV-2 RNA. The SARS-CoV-2 RNA is generally detectable in respiratory specimens during the acute phase of infection. Positive results are indicative of the presence of SARS-CoV-2 RNA; clinical correlation with patient history and other diagnostic information is necessary to determine patient infection status. Positive results do not rule out bacterial infection or co-infection with other viruses. The agent detected may not be the definite cause of disease. Laboratories within the United States and its territories are required to report all results to the appropriate public health authorities. Negative results do not preclude SARS-CoV-2 infection and should not be used as the sole basis for patient management decisions.

      Negative results must be combined with clinical observations, patient history, and epidemiological information. The Bio BCC19 Test Kit is intended for use by clinical laboratory personnel specifically instructed and trained in the techniques of in vitro diagnostic procedures.

      The Bio BCC19 Test Kit is only for use under the Food and Drug Administration’s Emergency Use Authorization.