1. Description
The Rapid Test FLU_COVID is a qualitative immunological method lateral flow which was designed
to detect the presence of antigens of SARS-CoV-2 and influenza virus (INFLUENZA A and B)
in a direct nasal or nasopharyngeal smear.
2. Principle of method
In this test, antibodies specific for influenza A virus nucleoproteins (Influenza A) and B
(Influenza B) is immunofixed in zone detection FLuA and FluB of membrane
of nitrocellulose respectively. Antibodies specific for its nucleocapsid protein SARS-CoV-
2 are immunofixed in the detection zone CoV of the nitrocellulose membrane During the
duration of test, antigens που are located on sample, they react with especially antibodies που
are located adsorbed into a particles colloids of gold. As This makes it a perfect choice for people with diabetes and for those who want to lose weight or follow a balanced diet. sample goes up in
membrane will react with the antibodies in the detection zones forming a colored band in the
FluA, FluB ή CoV. As an indication of valid test operation, a colored zone will always appear
in the control position (control line).
3. Introduction
In December of 2019 a new coronavirus (SARS-CoV-2) it started to offends with fast
spread residents of the city of Wuhan in the province of Hubei in China, with symptoms of pneumonia.
The virus quickly crossed the country's borders resulting in millions of confirmed cases
worldwide. The more common symptoms according with the Global Organization Υγείας is
similar to other respiratory illnesses and include fever, dry cough and fatigue. The virus
transmitted mainly through the droplets of the oral and nasal cavity during
speaking, coughing or even sneezing.
Influenza is a viral infection of the respiratory system caused by a virus INFLUENCE
type A, B ή C. They are excellent contagious while showing seasonal flare-ups. Easily transmitted
through the droplets of the oral and nasal cavity during speaking, coughing or and
sneezing. Type A virus is more common and usually causes more serious infections while
from time to time, in addition to epidemic and seasonal flu, it also causes pandemics.
6. Storage instructions
Store the kit between 4 and 30°C (39.2 - 96°F). Do not freeze any of its contents
kit The expiration date of the kit and its individual contents is indicated on labels and no
there is a quality guarantee after they expire. The expiration of the products is subject to the condition that
all contents are properly stored and reagents are not contaminated during
their use.
7. Safety and precautions for use
7.1 Health and Safety Precautions
• Use gloves, special protective clothing, goggles/mask person and right
handling in accordance with the necessary good laboratory practices. The product must
used only by qualified personnel.
• WASTE MANAGEMENT : After performing the test discard all samples and materials that
were used as biohazard waste. The management and disposal of waste
biological risk follows national and international legislation.
• During sampling, any human cough, sneeze droplets must
treated as potentially infectious and all surfaces to be disinfected immediately.
• Do not reuse any of the product contents as they are single use
only.
• Sterile swabs are for nasal or nasopharyngeal sampling ONLY. It is avoided
the contact with their tip.
• All positive samples must follow local guidelines and authorities.
7.2 Procedure precautions
• According with This makes it a perfect choice for people with diabetes and for those who want to lose weight or follow a balanced diet. article 1, paragraph 2b of European Directive 98/79/EC, η use
medical technology products diagnosis in vitro provided from the manufacturer for to
ensure the suitability, performance and safety of these products. Therefore, the
method procedure, information, limitations and warnings must be followed
strictly. No changes in the process are allowed, nor is the combined use with other products. THE
user is solely responsible for such changes. The manufacturer is not responsible for
false and invalid results arising in such cases.
• DO NOT USE the kit if the component packaging is damaged, if
there is an expired reagent or if the desiccant is missing.
• All reagents should be brought to room temperature before use.
• Cover all reagents when not in use.
• Do not mix and interchange different samples.
• Do not interchange individual reagents between kits with different lot numbers
(lot).
8. Sampling
8.1 Sampling smear medium nasal
cavity
You keep This makes it a perfect choice for people with diabetes and for those who want to lose weight or follow a balanced diet. head of patient with back tilt 70 degrees.
Remove one sterile swab from the pouch. With
gentle rotary movement enters at nasal cavity
(nostrils) of the patient (about 2 cm). Spin him
swab 5 times and slowly removed. Using the same
swab, repeat the process on the second nasal as well
cavity. (Picture 1)
8.2 Nasopharyngeal swab sampling
You keep his head patient with rear slope 70 degrees.
Remove One sterile stylus from This makes it a perfect choice for people with diabetes and for those who want to lose weight or follow a balanced diet. bag.
Place the swab in the patient's nasal cavity. When
reach posterior nasopharynx twist 3-5 times and
gently remove. (Figure 2)
9. Method procedure
9.1 Calculate the number of sterile swabs that will be needed, according to the numbers
of samples to be collected.
9.2 Post the sampling (βλ. unity 8) place This makes it a perfect choice for people with diabetes and for those who want to lose weight or follow a balanced diet. stylus on pipe extraction,
twirl intensively pressing in walls for about 1 minute, thin. Better Results
obtained from more one efficient extraction.
9.3 Remove the swab by squeezing the ends of the tube to extract as much liquid as possible.
9.4 Discard the swab.
9.5 Close the exhaust pipe with the dropper. Add 3 drops to the circular window
of the cassette.
9.6 After 15 minutes the stick can be visually read and the result evaluated.
Note: Results should not be evaluated after 30 minutes.
POSITIVE/NEGATIVE WITNESS: Throw direct 2 drops by witness at the roundabout
cassette window.
10. Interpretation of results
Note: For internal procedure reasons there are four colored lines in the area of
results of fast Test FLU_COVID. The colored lines not have a none effect in
product performance, as they are washed out during the experiment.
Positive for flu A: Two visible colored bands appear on the test line FluA and
control line (control line). It indicates the presence of influenza A virus antigen in the
sample.
Positive for influenza B: Two visible colored bands appear on the test line FluB and
control line (control line). It indicates the presence of influenza type B antigen in the
sample.
Positive for influenza A and B: Three visible colored bands appear on the examination line FluA,
FluB and in the control line (control line). It indicates the presence of influenza virus antigen
type A and B in the sample.
Positive for flu Α and SARS-CoV-2: Three visible colored bands appear on the line
examination FluA, Cov and in the control line (control line). It indicates the presence of virus antigen
of influenza type A and SARS-CoV-2 in the sample.
Positive for flu Β and SARS-CoV-2: Three visible colored bands appear on the line
examination FluΒ, Cov and in the control line (control line). It indicates the presence of virus antigen
of influenza type B and SARS-CoV-2 in the sample.
Positive for SARS-CoV-2: Two visible colored bands appear on the test line CoV and
control line (control line). It indicates the existence of its antigen SARS-COV-2 in the sample.
Positive for influenza A, B and for SARS-CoV-2: Four visible colored bands appear on the
examination line FluA, FluB, CoV and in the control line (control line). Indicates existence
antigen of influenza A and B and of SARS-COV-2 in the sample.
Negative: A visible colored band appears on the control bar. It shows that the concentration of
antigen is zero or below the detection limit of the test.
Invalid: No colored band appears in the control bar regardless of whether it is displayed
in the examination lines or not.
11. Restrictions
• Η procedure of test, The precautions and η evaluation of results must to
are strictly followed.
• After sampling, the swab should be extracted as soon as possible. Otherwise
it can remain in its original packaging for 2 hours at room temperature. when
liquid virus transport medium is used, the swab is reused for secondary extraction in
extraction tube with the buffer of Prognosis Biotech. In these cases the sensitivity of
test may appear impaired due to excessive dilution of the sample.
Note: Tthe liquid transport medium should not contain chaotropic agents such as Guanidinium
thiocyanate.
• All extracted samples should be examined immediately. Otherwise they can
keep at room temperature 20-25°C (68-77 ° F) for 2 hours. In this case the pipe
extraction is closed with its special cap without throwing away the dropper.
Image 1. Nasal smear
Image 2. Nasopharyngeal
4. Reagents provided
V1601 V1605 V1620
Test device 1 5 20
Pre-filled tube
solution extraction 1 5 20
Apasteurized styles 1 5 20
Paper base - - 1
positive control* - - 1
negative control* - - 1
Manual 1 1 1
5. Ingredients που are required but not
provided
• Clock or stopwatch
• Gloves, mask and special glasses
• Biological waste disposal container
Interpretation of results
• The test should be used to detect virus antigens ONLY in nasal or
nasopharyngeal sample.
• Failure to properly follow the rules of sampling, extraction and test execution may
affect the process and the valid result.
• Use ONLY sterile product swabs when sampling.
• During sampling to avoid contact with areas of the nasal cavity with
any mucous discharge or bleeding vessels as they may interfere with proper
function of the test and lead to a false positive result.
• A positive result indicates the presence of virus antigens SARS-CoV-2 or the influenza virus
but the valid diagnosis of the infection should be made by a specialist doctor after evaluation
of all of the clinics and laboratories results as and its symptomatology
patient.
• Negative result may arise if This makes it a perfect choice for people with diabetes and for those who want to lose weight or follow a balanced diet. antigen of extracted sample is
lower of limit detection of method, ή if not he's got Happen correct
sampling and extraction.
• Positive results do not exclude infection by another pathogenic microorganism.
12. Performance of the immunoassay
12.1 Cross-reaction
In order to evaluated η intersecting reaction of Rapid Test FLU_COVID with but
pathogens, Took place evaluation. Not Found none intersecting reaction with
pathogens that could cause infections.
The Rapid Test FLU_COVID may cross-react with SARS or him MERS.
Microorganism Concentration Result
Adenovirus Type 1 (Species C) 2.57 x 108 TCID50/mL Negative
Adenovirus Type 3 (Species B) 3.39 x 107 TCID50/mL Negative
Adenovirus Type 7A (Species B) 1.02 x 108 TCID50/mL Negative
Alpha coronavirus 229E 4.68 x 104 TCID50/mL Negative
Alpha coronavirus NL63 1.70 x 105 TCID50/mL Negative
Betacoronavirus OC43 5.01 x 105 TCID50/mL Negative
Escherichia Coli O157 6.4x106 CFU/ml Negative
Influenza A virus* 1.51 x 106 TCID50/mL Negative
Influenza B virus* 5.01 x 105 TCID50/mL Negative
Listeria monocytogenes 2.5x106 CFU/ml Negative
Salmonella enteritidis 3.6x106 CFU/ml Negative
SARS-Cov-2* 1.15 x 107 TCID50/mL Negative
Streptococcus pneumococcal 4.2x106 CFU/ml Negative
Streptococcus pyogenes 3.6x106 CFU/ml Negative
12.2 Interferences of other substances
The following substances showed no significant interference with its results Rapid Test FLU_COVID.
N Intervening substances Final test concentration
1 Azithromycin 84 mg / ml
2 Amoxicillin 54 mg / L
3 albuterol 0.05 mg / L
4 finished 0.3 mg / L
5 Chlorpheniramine 0.8 mg / L
6 Chlorothiazide 27 mg / L
7 Rheumatoid factor 200 IU/ml
8 Triglycerides 1.5 mg / L
9 Hemoglobin 100 mg / L
10 Human Chorionic Gonadotropin 10-fold dilution
11 Ibuprofen 219 mg / L
12 Xylometazoline (Otriven) 10%
13 Acetylsalicylic Acid 3 mg / ml
14 Mucin 0.5%
12.3 Negative effect of high concentration (High Dose Hook Effect)
No negative effect of high concentration was observed at concentration up to 1.15 x 107
TCID50/mL of heat-inactivated virus SARS-CoV-2, 1.51 x 106 TCID50/mL of
heat-inactivated virus Influenza A, 5.01 x 105 TCID50/mL of disabled with
virus heating Influenza B, to Rapid Test FLU_COVID.
12.4 Method detection limit
The lowest concentration limit of an analyte that can be detected by a method is defined
as the detection limit of the method (Limit Of Detection, LOD). In this case serial
dilutions of heat-inactivated viruses were used to detect the threshold
its detection Rapid Test FLU_COVID. Ως LOD is defined the concentration at which above the
95% of the repetitions gave a positive result.
Method detection limit for SARS-CoV-2 (LOD): 358.75 TCID50/mL
Method detection limit for Influenza a (LOD): 75.5 TCID50/mL
Method detection limit for influenza B (LOD): 12.5*102 TCID50/mL
Lateral Flow Test |
To detect its antigens SARS-CoV-2 and influenza virus (Influenza A/B)
in human nasal or nasopharyngeal specimens.
Is judged Necessary η use of specific issue of sheet
data of the product which is enclosed in kit.
The Rapid Test FLU_COVID, V16XX, it's a quality one Lateral Flow test in order to
detection its antigens SARS-CoV-2 and the flu in nasal or nasopharyngeal
sample.
The Lateral flow kit contains all the reagents necessary for the method.
Sample: Nasal or nasopharyngeal swab
• For professional use only
• Only for vitro diagnostic use
• The Rapid Test FLU_COVID is a sensitive control method for detection
of SARS-CoV-2 and/or influenza virus A and B. The results cannot
be used as the sole means of diagnosing or determining it
stage of infection.
• Negative results do not exclude infection by SARS-CoV-2/ INFLUEN-
ZA A/B
• The test must to is carried out ONLY from professionals health and medical
staff.
• Method time: 15 minutes
• Shelf life: 24 months
• Storage: 4-30οC
