NatTrol viral PCR control

 

 

 

 

CATALOG# 0831042
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INTENDED USE

NATtrol™ SARS-CoV-2 (recombinant) Stock is designed to guage the effectivity of nucleic acid checks for dedication of the presence of SARS-CoV-2 N gene. NATtrol™ SARS-CoV-2 (recombinant) Stock will even be used for validation of medical assays, progress of diagnostic checks and training of laboratory personnel.

NATtrol™ SARS-CoV-2 (recombinant) Inventory Catalog Quantity: 0831042
This product was manufactured in a
facility which has a High quality Administration
System that’s ISO 13485 licensed.
Catalog
Quantity
Temperature
Limitation
Lot Quantity Expiration

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PI0831042
Revision: 01 PCA# 20-128
Efficient Date: 03/11/2020

PRODUCT DESCRIPTION:

NATtrol™ SARS-CoV-2 (recombinant) Inventory* is
formulated with purified, intact bacterial cells containing
artificial SARS-CoV-2 sequence. The cells have been
chemically modified to render them non-infectious and
fridge secure. Every vial incorporates 1.Zero mL of NATtrol™
SARS-CoV-2 (recombinant) Inventory in a purified protein
matrix.

INTENDED USE:

• NATtrol™ SARS-CoV-2 (recombinant) Inventory is
designed to guage the efficiency of nucleic
acid assessments for dedication of the presence of
SARS-CoV-2 N gene. NATtrol™ SARS-CoV-2
(recombinant) Inventory can be used for
validation of medical assays, growth of
diagnostic assessments and coaching of laboratory
personnel.

ETIOLOGIC STATUS/BIOHAZARD TESTING:

• NATtrol™ inactivation was carried out on the inventory
used to formulate this product. The inactivation
was verified in an ordinary microbiological progress
protocol.
• Purified protein matrix used within the manufacture of
this product is handled with 0.09% sodium azide. It
was manufactured from Human Serum Albumin
(HSA) that has been examined and located non-reactive
on the donor stage for HIV-1/HIV-2 Antibody,
HBsAg and HCV Antibody by FDA licensed donor
screening check strategies. All supplies are additionally
examined for HIV-1 and HCV by FDA authorised
Nucleic Acid Take a look at (NAT) strategies. Warmth
inactivated Fetal Bovine Serum (FBS) used within the
manufacture of this product meet relevant
USDA necessities for abattoir sourced animals,
traceability and nation of origin. The supplies
had been collected at USDA licensed institutions
or legally imported from nations acknowledged by
the USDA as negligible or managed for threat for
Bovine Spongiform Encephalopathy (BSE) and
different unique illness brokers. Donor animals had been
inspected ante and publish mortem on the abattoir as
required by the USDA.

PRECAUTIONS:

• Though NATtrol™ SARS-CoV-2 (recombinant)
Inventory incorporates inactivated micro organism, it needs to be
dealt with as if doubtlessly infectious.
• Use Common Precautions when dealing with this
product.
• To keep away from cross-contamination, use separate
pipette suggestions for all reagents.
RECOMMENDED STORAGE:
• NATtrol™ SARS-CoV-2 (recombinant) Inventory*
needs to be saved at 2-8°C.
INSTRUCTIONS FOR USE:
• Extract nucleic acid prior to make use of in downstream
assays.

TABLE 1:

Catalog Quantity Focus
(Ct Vary)**
0831042 22-25
**Cycle threshold (Ct) vary primarily based on in-house actual time PCR
assay concentrating on the SARS-CoV-2 N gene area.
DO NOT USE IN HUMANS. FOR RESEARCH USE
ONLY. NOT FOR USE IN DIAGNOSTIC
PROCEDURES.

These merchandise are supposed for analysis, product
growth, high quality assurance or manufacturing use.
These merchandise are NOT supposed to be used within the
manufacture or processing of injectable merchandise topic to
licensure below part 351 of the Public Well being Service Act
or for some other product supposed for administration to
people.

Lieven Gevaert, Bio-engineer Gentaur