INSTRUCTIONS FOR USE:
These controls have been examined with the BioFire Diagnostics FilmArray Respiratory Panel 2 (RP2) assay
and provide all anticipated outcomes for the targets listed in Desk 1.
Adjust to producer instructions for loading pouches.
Extract Nucleic Acids prior to utilize in assays that are not sample to final result.
PRODUCT DESCRIPTION:
NATtrol Meningitis/Encephalitis (ME) Controls (NATMECBIO)* are formulated with purified, intact virus particles, bacterial and fungal cells which had been chemically modified to render them non-infectious and fridge regular. Each administration pack accommodates 6 x 0.2 mL vials of ME Administration 1 and 6 x 0.2 mL vials of ME Administration 2. NATtrolTM ME Controls are geared up in a purified protein matrix that mimics the composition of an actual medical specimen.
NATtrol Meningitis/Encephalitis Panel
NATMEP-BIO
The Zeptometrix NATtrol ME Panel is designed to guage the effectivity of nucleic acid checks for willpower of the presence of viral, bacterial and fungal nucleic acids. NATMEP-BIO can be utilized for verification of medical assays, development of diagnostic checks and training of laboratory personnel. NATMEP-BIO accommodates intact organisms and must be run in a trend equal to that used for medical specimens.
INTENDED USE:
NATtrol ME Controls are designed to guage the effectivity of nucleic acid checks for willpower of
the presence of viral, bacterial and fungal nucleic acids. NATMEC-BIO can be utilized for assessing lot-to-lot
check out package deal effectivity and training of laboratory personnel.
NATMEC-BIO accommodates intact organisms and must be run in a trend equal to that used for medical
specimens.
Zeptometrix NATtrol Meningitis
ETIOLOGIC STATUS/BIOHAZARD TESTING:
NATtrol™ inactivation was carried out on the shares used to formulate each administration. The inactivation was verified by the absence of growth in validated tissue custom primarily based infectivity assays and growth protocols.
Purified protein matrix used throughout the manufacture of this product is dealt with with 0.09% sodium azide. It was manufactured from provides which had been examined and positioned non-reactive on the donor stage for HIV-1/HIV-2 Antibody, HBsAg and HCV Antibody by FDA licensed donor screening check out methods.
All provides are moreover examined for HIV-1 and HCV by FDA authorised Nucleic Acid Test (NAT) methods. Heat inactivated bovine primarily based provide provides used throughout the manufacture of this product meet related USDA requirements for abattoir sourced animals, traceability and nation of origin. The provides have been collected at USDA licensed establishments or legally imported from worldwide areas acknowledged by the USDA as negligible or managed for hazard for Bovine Spongiform Encephalopathy (BSE) and completely different distinctive sickness brokers. Donor animals have been inspected ante and put up mortem on the abattoir as required by the USDA.
PRECAUTIONS:
Although NATMEC-BIO accommodates inactivated organisms, it must be handled as if most likely infectious.
Use Widespread Precautions when coping with this product.
To stay away from cross-contamination, use separate pipette strategies for all reagents.
Human Meningitis B Porin A (MenB PorA) antibody positive control serum
