Product Manual

7
Viral Strain Tested
Adenovirus*
Measles**
Human coronavirus**
Cytomegalovirus**
Enterovirus**
Human metapneumovirus**
Mumps virus**
Respiratory syncytial virus; Type B*
Epstein Barr Virus**
Rhinovirus; Type 1A**
Human parainfluenza; Type 1, 2 and 3*
* In the study the virus was confirmed using FDA approved
immuno-fluorecence assay
**In the study the virus was confirmed using commercially available PCR
(not approved by FDA).
Bacterial Strain Tested
Bordetella pertussis
Chlamydia pneumoniae
Corynebacterium sp.
Escherichia coli
Hemophilus influenzae
Lactobacillus sp.
Legionella spp
Moraxella catarrhalis
Mycobacterium tuberculosis avirulent
Mycoplasma pneumoniae
Neisseria meningitides
Neisseria sp.
Pseudomonas aeruginosa
Staphylococcus aureus: Protein A Producer
Staphylococcus epidermidis
Streptococcus pneumoniae
Streptococcus pyogenes
Streptococcus salivarius
Interference
The interference study was conducted using medically relevant
concentrations of the potentially interfering substances listed below
with two strains each of influenza type A and type B to assess the
potential interference of the substances on the performance of the
Status Flu A & B test.
The test was conducted by spiking each substance into samples
containing the lowest detectable virus level of influenza Type A or Type
B for the positive interference testing and into samples without
influenza virus for the negative interference testing. Each substance had
no inhibitory effect on the Status Flu A & B test at the concentration
listed in the table below.
Mucin 1 mg/ml
Whole Blood 1%
Phenylephrine 10 mg/mL
Oxymetazoline 10 mg/mL
Sodium Chloride with preservative 20%
Beclomethasone 1 mg/mL
Dexamethasone 1 mg/mL
Flunisolide 1 mg/mL
Triamcinolone 1 mg/mL
Budesonide 1 mg/mL
Mometasone 1 mg/mL
Fluticasone 0.5 mg/mL
Luffa opperculata, sulfur 1%
Galphimia glauca 1%
Histaminum hydrochloricum 1%
Live intranasal influenza virus vaccine 1%
Benzocaine 1 mg/mL
Menthol 1 mg/mL
Zanamivir 1 mg/mL
Mupirocin 1 mg/mL
Tobramycin 1 mg/mL
Substances Tested Concentration Tested
The performance of Status Flu A & B was evaluated with nasal and
nasopharyngeal swab samples obtained from patients infected with the 2009
H1N1 influenza virus consisting of sixty six (66) frozen clinical Nasal and
Nasopharyngeal samples that had previously tested positive for 2009 H1N1 by
FDA-cleared CDC RT-PCR test. The Status Flu A & B test detected 71% (47/66)
of the CDC RT-PCR test positive specimens. The detection rate was 91% with
the higher tittered specimens and 38% with the lower titered specimens.
NOTE: The performance characteristics of the test with cultured avian
influenza A subtype H5N1 virus, or with specimens from human infected
with H5N1 or other avian influenza viruses have not been established.
Analytical Specificity
Cross-reactivity
The potential cross-reactivity of the non-influenza respiratory pathogens and
other microorganisms with which the majority of the population may be infected
was tested using the Status Flu A & B test at medically relevant levels, 10
6
cfu/mL
for bacteria and 10
5
pfu/mL for non-flu viruses. None of the organisms or viruses
listed in the table below gave a positive result with Status Flu A & B at the tested
concentration.
Precautions/Warnings
· For in vitro diagnostic use only.
· Do not use after the expiration date.
· Use only the swabs provided for collecting swab samples. Other swabs
may not work properly.
· Two forms of Extraction Reagent are provided. Use Extraction Reagent
in capsules to test swab samples, and Extraction Reagent in a bottle to
test nasopharyngeal wash/aspirate samples.
· Do not smoke, eat or drink in areas in which specimens or kit reagents
are handled.
· Extraction Reagent is slightly caustic. Avoid contact with eyes, sensitive
mucous membranes, cuts, abrasions, etc. If the reagent comes in
contact with skin or eyes, flush with a large volume of water.
· Wear disposable gloves while handling kit reagents or specimens and
thoroughly wash hands afterwards.
· All specimens should be handled as if they are capable of transmitting
disease. Observe established precautions against microbiological
hazards throughout all procedures and follow the standard procedures
for proper disposal of specimens and test devices.
· The Status Flu A & B test device should remain in its original sealed
pouch until ready for use. Do not use the test if the seal is broken or the
pouch is damaged.
· Performance characteristics for influenza A were established when
influenza A/H3 and A/H1 were the predominant influenza A viruses in
circulation. When other influenza A viruses emerge, performance
characteristics may vary.
· If infection with a novel influenza A virus is suspected based on current
clinical and epidemiological screening criteria recommended by public
health authorities, specimen should be collected with appropriate
infection control precautions for novel virulent influenza viruses and sent
to state or local health departments for testing. Viral culture should not be
attempted in these cases unless a BSL 3+ facility is available to receive
and culture specimens.
Storage and Stability
The Status Flu A & B test may be stored at 2–30°C (35–86°F) in the original
sealed pouch, away from direct sunlight. Kit contents are stable until the
expiration date printed on the box.
Specimen Collection and Preparation
· Inadequate or inappropriate specimen collection, storage, and transport
are likely to yield false negative test results. Training in specimen
collection is highly recommended because of the importance of
specimen quality.
· To collect nasopharyngeal or nasal swab specimens, the swab provided
in the Status Flu A & B test kit should only be used.
· Using 2.5 mL of sterile saline solution is recommended to collect
wash/aspirate specimens.
· Use fresh samples for best performance. Freshly collected specimens
should be tested immediately. If necessary, aspirate specimens may be
stored for up to 8 hrs at room temperature or up to 24 hrs at 2–8°C, and
swab samples for up to 4 hrs at room temperature or up to 8 hrs at
2–8°C. Aspirate samples can be frozen for up to 7 days.
· If transport of the samples is required, use saline solution, PBS, BD™
Universal Viral Transport Medium, M4-RT Medium, or Copan UTM-RT
Medium. These transport media have been tested and shown not to
interfere with the performance of the test.
2
Flu A & B Specimen Collection Procedures
Good sample collection is the most important first step for an accurate
test result. Therefore, follow below instruction carefully to obtain as
much secretion as possible.
Nasal Swab Specimen:
Using a flocked swab provided in the Status Flu kit, gently insert the swab
approximately 1/4” into the anterior nares (just inside the nasal orifice).
Rotate the swab a few times, and repeat in the second nostril, using the
same swab.
Nasopharyngeal Swab Specimen:
Using a flocked swab provided in the Status Flu kit, insert the swab into the
nostril, gently rotating the swab inward until resistance is met at the level of
the turbinates. Rotate the swab a few times against the nasopharyngeal wall
and then withdraw the swab.
Nasopharyngeal Aspirate Specimen:
With the patient’s head slightly hyper-extended, instill 2.5 mL or less (the
minimal volume of saline required per patient’s size and age) of sterile saline
into the patient’s nostril. Gently thread the tube through the external nostril,
into the nasopharnyx. Aspirate wash solution by gentle suction with rotating
movement.
NOTE: Catheter should remain in nasopharynx no longer than 10 seconds.
Repeat the procedure until adequate sample volume (2.5ml) is obtained.
Nasopharyngeal Wash Specimen
Adults and Older Children
Position the patient comfortably in a sitting position, with the neck slightly
hyper-extended. Prior to the procedure, have the patient blow their nose.
Using a sterile syringe, introduce 2.5 ml of sterile saline into one nostril. If
possible, have the patient retain the saline for a few seconds. Place
specimen container directly under the nose with slight pressure on the upper
lip. Tilt the head forward and allow the fluid to flow into the specimen
container. Repeat the procedure on other nostril, collecting fluid into the
same container.
Infant and Younger Child:
The parent should wrap one arm around the child in a manner that will
restrain the child’s body and arms. Fill a bulb syringe with 2.5 ml of sterile
saline, depending on the size of the patient, and instill saline into one nostril,
while the head is tilted back. Release the pressure on the bulb to aspirate the
specimen back into the bulb. Transfer the specimen into specimen
container. Repeat the procedure on other nostril, transferring the second
specimen into the same specimen container.
Test Procedure
Procedural Notes
· The test procedure provided must be followed to obtain accurate and
reproducible results.
· Reagents, specimens, and devices must be at room temperature
(18–30°C) for testing.
· Do not open the foil pouch until you are ready to perform the test.
· Several tests may be run at one time.
· Label the device with the patient identification or control to be tested.
· Place test device on a level surface.