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HSV-1 Gen II Primer Pair
(50 µL)
(English)
REF MOL9037
Rev. A
For use outside the United States
For in vitro Diagnostic Use
INTENDED USE
Focus Diagnostics’ HSV-1 Gen II Primer Pair (with integrated CFR610 probe) is intended for laboratory use to amplify and detect the HSV-1 DNA
polymerase gene.
DESCRIPTION OF PRIMER PAIR AND TARGET
Herpes Simplex Virus (HSV) is a common human pathogen found worldwide and is known to infect humans. The Focus Diagnostics’ HSV-1 Gen
II Primer Pair, when used with real-time polymerase chain reaction (PCR) methodologies, enables amplification and detection of HSV-1 nucleic
acid. The primers and integrated probe sequences target a conserved region of the HSV-1 polymerase gene.
ANALYTE SPECIFIC REAGENT PERFORMANCE
Studies have indicated that the primers did not cross react with other viruses including EBV, VZV, CMV, BKV, Enterovirus 71, JCV, Hepatitis B,
Hepatitis C, HIV-1, HIV-2, HHV-6, HHV-7, HHV-8, HPV-18, Adenovirus 1, Adenovirus 7, Parvovirus, Rotavirus, St. Louis Encephalitis Virus,
Rubella, Measles and Mumps, or with bacteria including Neisseria meningitidis, Haemophilus influenzae, Streptococcus pneumoniae,
Streptococcus agalactiae, Escherichia coli O157H7 , Listeria monocytogenes, Mycobacterium tuberculosis,. Chlamydia trachomatis, Neisseria
gonorrhoeae, Lactobacillus acidophilus, Candida albicans, Citrobacter freundii, Citrobacter koseri, Cryptococcus neoformans, Enterobacter
aerogenes, Enterococcus faecium, Enterococcus faecalis vanB, Klebsiella pneumoniae, , Mycoplasma pneumoniae , Proteus mirabilis,
Pseudomonas aeruginosa, Staphlococcus aureus, Bacteroides fragilis, Chlamydia trachomatis , Clostridium difficile, Corynebacterium genitalium,
Gardnerella vaginalis , Mycoplasma genitalium , Mycoplasma hominis , Mobiluncus mulieris, Proteus vulgaris, Staphylococcus epidermidis,
Staphylococcus saprophyticus, Streptococcus pyogenes, Streptococcus mitis, Trichomonas vaginalis, Toxoplasma gondii and Ureaplasma
urealyticum .Furthermore, nucleic acid sequence databases indicated that the primers did not have significant homology with other pathogens or
with human DNA.
MATERIALS PROVIDED
Product
HSV-1 Gen II Primer Pair (50 µL per vial)
Concentration
25 µM
Part Number
MOL9037
Cap Color
Brown
Number of Vials
1
SHELF LIFE AND HANDLING
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Store at -10 to -30 ºC (do not use a frost-free freezer). Store product in the dark and protect from light.
Allow to thaw at room temperature (approximate range 18 to 25 ºC) before use.
Once thawed, store the unused product at 2 to 8 ºC for no more than 30 days. Do not refreeze.
When properly stored, product is stable through the end of the month indicated on the expiration date on the packaging. Do not use beyond
the expiration date.
WARNINGS AND PRECAUTIONS
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Use product in accordance with good laboratory practices. Wear personal protective equipment such as (but not limited to) gloves and lab
coats when handling. Wash hands thoroughly after handling.
Do not pipette by mouth. Do not smoke, drink, eat, handle contact lenses or apply make-up in areas where product is being used.
Dispose of unused product according to local, state and federal regulations.
Contamination of this product can produce erroneous results. Use aseptic techniques, uni-directional laboratory workflow, dedicated areas,
and other standard techniques applicable to molecular amplification methodologies.
INSTRUCTIONS FOR USE
Each laboratory should establish its own standard operating procedures and instructions for using the HSV-1 Gen II primer pair in a polymerase
chain reaction assay.
LIMITATIONS
The dye labeled primer utilizes CFR610 as the fluorophore. Detection of this fluorophore requires an instrument capable of fluorescence excitation
at a wavelength of approximately 590 nm, and fluorescent detection at a wavelength of approximately 610 nm.
HSV-1 Gen II Primer Pair
Page 2
The use of Scorpions® probes for human in vitro diagnostic purposes is covered by a license to Focus Diagnostics, Inc. from DxS, Ltd.
Black Hole Quencher™, CAL Fluor™, Quasar™ dyes are trademarks of Biosearch Technologies, Inc. ('BTI'). Black Hole Quencher, CAL Fluor and
Quasar dye technology is licensed pursuant to an agreement with BTI, and these products are sold exclusively for clinical, diagnostic, or research and
development purposes.
ORDERING INFORMATION
Telephone:
(800) 838-4548 (U.S.A. only)
Fax:
(562) 240-6510
(562) 240-6500 (International)
PI.MOL9037
Rev. A
Date written: 30 Oct 2013
TECHNICAL ASSISTANCE
Telephone:
Fax:
(800) 838-4548 (U.S.A. only)
(562) 240-6526
Visit our web site at: www.focusdx.com
(562) 240-6500 (International)
Cypress, California 90630, U.S.A.