NATtrol™ inactivation was carried out on the shares used to formulate every administration. The inactivation was verified by the absence of enchancment in validated tissue customized based infectivity assays and enchancment protocols.
Purified protein matrix used all through the manufacture of this product is handled with 0.09% sodium azide. It was manufactured from gives which have 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 try strategies.
All gives are furthermore examined for HIV-1 and HCV by FDA authorised Nucleic Acid Check (NAT) strategies. Warmth inactivated bovine based present gives used all through the manufacture of this product meet associated USDA necessities for abattoir sourced animals, traceability and nation of origin. The gives have been collected at USDA licensed institutions or legally imported from worldwide locations acknowledged by the USDA as negligible or managed for hazard for Bovine Spongiform Encephalopathy (BSE) and fully completely different distinctive illness brokers. Donor animals have been inspected ante and put up mortem on the abattoir as required by the USDA.
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 might be utilized for assessing lot-to-lot
try bundle effectivity and coaching of laboratory personnel.
NATMEC-BIO accommodates intact organisms and should be run in a vogue equal to that used for medical
specimens.
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 might be utilized for verification of medical assays, growth of diagnostic checks and coaching of laboratory personnel. NATMEP-BIO accommodates intact organisms and should be run in a vogue equal to that used for medical specimens.
PRODUCT DESCRIPTION:
NATtrol Meningitis/Encephalitis (ME) Controls (NATMECBIO)* are formulated with purified, intact virus particles, bacterial and fungal cells which have been chemically modified to render them non-infectious and fridge common. Every 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 equipped in a purified protein matrix that mimics the composition of an precise medical specimen.
PRECAUTIONS:
Though NATMEC-BIO accommodates inactivated organisms, it should be dealt with as if almost certainly infectious.
Use Frequent Precautions when dealing with this product.
To avoid cross-contamination, use separate pipette choices for all reagents.
RECOMMENDED STORAGE:
NATtrol RP2 Controls should be saved at 2-8°C.
INSTRUCTIONS FOR USE:
These controls have been examined with the BioFire Diagnostics FilmArray Respiratory Panel 2 (RP2) assay
and supply all anticipated outcomes for the targets listed in Desk 1.
Alter to producer directions for loading pouches.
Extract Nucleic Acids previous to make the most of in assays that aren’t pattern to consequence.