ImunoAce RSV 20 tests/ box  95 euro

20 Flu Tests in a kit for immediate use at the test site

Product

1. ImunoAce Flu Brochure(PDF:980KB)
2. ImunoAce Flu Package Insert(PDF:213KB)
3. ImunoAce Flu Ｑ＆Ａ(PDF:66KB)
4. ImunoAce Flu Testing Procedures(PDF:322KB)
5. ImunoAce Flu

ImunoAce Flu

Swab

Product features

1. ■Dramatic improvement in sensitivity at low concentrations.
2. (The minimum detection limits: Flu A 7.5×103 TCID50/test, FluB 7.5×104 TCID50/test)
3. ■New technology reduces nonspecific reaction.
4. ■Rapid determination.
5. (Can be determined after three minutes if lines appear on the test plate.)
6. ■Easy to use extraction vial.

Test procedure

 

■ Test procedure

1. Drip an 80～120μL specimen into the sample placing area of the test plate.

2. Observe the reading area of the test plate after 3～8 min and interpret the result as follows.

■ Interpretation

A-positive, if a black line is observed in the reading areas of [A] and [C]

B-positive, if a black line is observed in the reading areas of [B] and [C]

Negative, if a black line is not observed in the reading area [A] and [B] but the color is observed in the reading area [C]

Warnings and Precautions

1. Handling

1) Reagents contain sodium azide, which is harmful if inhaled, swallowed or in contact with skin. After contact with eyes, wash immediately with plenty of water over 15 minutes. Consult doctor if necessary.
2) After contact with skin or cloth, wash immediately with soap or plenty of water.
2. Collection, Preparation, and Storage
1) ImunoAce Flu react to Influenza Type A and Type B. It will not react to Influenza Type C virus.
2) ImunoAce Flu is the rapid test kit which detects Influenza Type A and Type B virus antigen. Conclusive diagnostic should be made by medical doctors in conjunction with clinical condition and other test result such as and isolation culture.
3) Follow test procedure written in the package insert.
4) Store kit at room temperature or refrigerated (2-30℃). Avoid direct sunlight.
5) Leave the test device sealed in its foil pouch until just before use.
6) Do not touch the test surface or subject it to abrasion.
7) Deposition in the extraction reagent will not affect test result.
8) Do not use reagents beyond the expiration date.
9) The attached swabs are suitable for nasal sampling. Use a pharyngeal sterile rayon swab (option) for pharynx sampling.
10) Do not use the swab when it is broken, bent or stained.
11) Avoid the following usages because it may raise a possibility that the stick breaks.
– the usage with excess force, strong pushing or excess twist load the stick, especially to the thin area of stick.
– the usage with an intentional transformation (it bends, curves and fold back) to the stick.
12) Do not keep forcibly insertion operating when the insertion distance is obviously shorter than usually in the site.
Especially, there is a possibility that the resistance imposes to the stick when the sample is collected from the infant and the patient with narrow nasal cavity. Do not rub strongly putting power on the stick in such case. Moreover, do not rotate the stick forcibly.
13) Any mucus mass on the tip of the swab should be gently removed with gauze. Do not wipe the tip too hard.
Mucosal epidermal cells should remain on the tip for testing.

3. Disposal
1) Since test plates, sterile swabs, extraction vials, filtered nozzles, dropper tubes, filtered tips, remaining specimens, etc., may cause infections, they should be autoclaved (121℃, 20min) or soaked in 0.1% hypochlorite for more than one hour. When reagents, remaining reagents or their accessories are disposed of, they should be treated in accordance with the laws and regulations concerning medical waste disposal and water pollution control.
2) In the sample extract, 0.09% of sodium azide is contained as preservative. When solution containing sodium aside continues to be discarded over a long period of time, explosive metallic azide may be produced if a drain is made of metal. Therefore, it should be discarded with a large quantity of water.

Reference Data

■Correlation
Influenza A virus

Nasal awab Viral isolation culture method
Positive Negative Total
ImunoAce Flu Positive 100 9 (*1) 109
Negative 6 187 193
Total 106 196 302
Positive concordance rate: 94.3%
Negative concordance rate: 95.4%
Total concordance rate: 95.0%
(*1) Eight of these specimens are positive and one is negative when tested by the RT-PCR method.
Influenza B virus

Nasal awab Viral isolation culture method
Positive Negative Total
ImunoAce Flu Positive 69 3 (*2) 72
Negative 0 230 230
Total 69 233 302
Positive concordance rate: 100%
Negative concordance rate: 98.7%
Total concordance rate: 99.0%
(*2) One of these specimens is positive and two are negative when tested by the RT-PCR method.

Influenza Detection Product Summary

■Measuring principle Immunochromatography
■Validity 18 months
■Storage store at 2-30℃
■Detection time 3～8 minutes

Capillia Flu detection questions and answers

Q1.
The positive line disappeared 8-minutes later. How should we evaluate the result?
A1.
When a sample is placed on the sample placement area of the test plate, the colloidal platinum-gold labeled Influenza viral antibody
(hereafter referred to as “labeled antibody”) dissolves and migrates through the developing area by capillary action. The labeled antibody
marginally clumps together due to sample-derived components, and may move more slowly across the test line area. The line
disappeared because all the labeled antibodies went through the area. If the black line disappeared after 8-minutes, the test result was
negative. Please evaluate after 8-minutes have past, especially for a weakly positive reaction.

Q2.
An ImunoAce Flu examination of a patient with a fever and symptoms of Influenza proved to be negative. What reason could be possible?
A2.
ImunoAce Flu is a reagent which rapidly detects influenza A viral antigens and influenza B viral antigens. When ImunoAce Flu is applied to
influenza A viral antigens, the minimum detection sensitivity is 7.5 x 103 TCID50/test, while it is 7.5 x 104
TCID50/test when applied to
influenza B viral antigens. However, the total quantity of the influenza viral antigens in the examined specimens from a patient is smaller
than the minimum detection sensitivity, and the reading will be negative. Therefore, the reading that the specimen is negative does not
necessarily mean “noninfected” from flu virus. Finally, the doctor in charge should make a diagnosis considering other test results
including clinical indications, isolated incubations of the virus, etc.

Q3.
It took longer than usual for the test material to develop from the placement time. The control line was also less clear than usual. What
could be the cause?
A3.
One of the reasons may be insufficient test material. Add one more drop of the specimen extract. If you hold the extraction vial at a slant, it
might cause less of the liquid to fall. Keep the extraction vial horizontal, and, holding the middle part of the vial carefully, add three drops of
the specimen extract to the sample placing area. Furthermore, test development may be delayed if the test plate deteriorates because of
absorbed moisture. This can be prevented by conducting the test immediately after the test plate is unsealed. If another test plates
produce the same results, please contact us.
Q4.
Both [A] and [B] lines appeared in the reading area on the test plate. What is the likely reason?
A4.
Clinical case where the examined specimen has been infected by both A and B influenza suggests that it is a double positive. The
examined specimen should be considered both A and B positive. However, the unclearness of either line indicates a nonspecific reaction
caused by the derivative ingredient of the specimen.
Q5.
Do you have data for the dates of diseases and “positive” rates using the ImunoAce Flu kits?
A5.
The following six facilities can provide evaluations.
Takasaki Pediatrics Hospital, Shindo Pediatrics Hospital, Yamashita Pediatrics Hospital, Yokoyama Pediatrics Hospital, Shibao Clinic, and
Iwaya Pediatrics Clinic.

 

ImunoAce Flu Testing Procedure

Methods of specimen collection

Sampling by pharyngeal swab, nasal swab, or nasal aspirate Specimen dispensing

• Use a separately sold
• pharyngeal sterile swab
• for pharynx sampling.
• Collect specimen with the
• swab enclosed in the kit.
• After suction, soak the swab
• and collect the specimen.
• Sample preparation
• Tear off the top seal of
• the extraction vial with
• the enclosed opener.
• Soak the swab which collected
• the specimen, stir well, and
• squeeze the liquid from the
• swab.

• 

Firmly attach the filter
nozzle to the top of the
extraction vial.

Reading the result
3~8min. 8min.
Hold the middle of
the extraction vial
with fingers and
release three drops
of the sample.

Lieven Gevaert

A-positive B-positive Negative

* See the product insert when using transport medium
or saline.
* No aspirators and pharyngeal sterile swabs are
included in this kit.