Products/Rapid-Tests human/Influenza AB Complete

Keul-o-test

Influenza A/B Complete

For Nasal Swab Specimen

KGST132 
DIMDI Reg.-Nr.: DE/CA22/1116-136-IVD

INTENDED USE
Keul-o-test Influenza A/B Complete is a rapid qualitative in vitro assay that detects influenza type A and B antigens (nucleoprotein) extracted from the respiratory specimens. The test is designed to detect nucleoproteins of A and B core subtypes, independent of H and N surface proteins. For professional use only.

FUNCTIONING
The Keul-o-test Influenza A/B Complete is a sandwich immunoassay test. The test cassette contains a nitrocellulose membrane strip with an immobilized mouse anti-influenza antibody in the test reaction zone (T). Another antibody, a goatanti-mouse antibody is immobilized in the control reaction zone (C) on the nitrocellulose membrane.

KIT STORAGE
The Keul-o-test Influenza A/B Complete should be stored at room temperature in the original sealed pouch. The expiration date was determined under normal laboratory conditions.

MATERIALS PROVIDED

  1. Keul-o-test Influenza A/B Complete test panel.
  2. Instructions.
  3. Swab.
  4. Test tube
  5. Extraction Buffer.

PRECAUTIONS
The Keul-o-test Influenza A/B Complete should be stored at room temperature 4-30oC (40-86oF).  The test panel is sensitive to humidity as well as to heat.  Perform the test immediately after removing the test panel from the foil pouch.  Do not use it beyond the expiration date.

WARNINGS

  1. For in vitro diagnostic use only.
  2. Do not eat or smoke while handling specimens.
  3. Wear protective gloves while handling specimens. Wash hands thoroughly afterwards.
  4. Avoid splashing or aerosol formation.
  5. Clean up spills thoroughly using an appropriate disinfectant.
  6. Decontaminate and dispose of all specimens, reaction kits and potentially contaminated materials, as if they were infectious waste, in a biohazard container.
  7. Do not use the test kit if the pouch is damaged or the seal is broken.

SPECIMEN COLLECTION

  1. Insert the sterile swab into nostril which shows the most secretion.
  2. Very gently rotate and push the swab until resistance is met at level of the turbinates.
  3. Gently rotate the swab against nasal wall for a few times.
img/schnelltest/influenza_ab_complete/probenahme.jpg

SPECIMEN PREPARATION

  1. Put 12 drops Extraction Buffer in the test tube,
  2. Place the specimen swab in the tube and swirl it vigorously to mix the reagents for at least 1 minute.
  3. Then expunge as much liquid as possible from the swab by pressing and rotating the fiber portion against the wall of the tube.  Discard the swab.  Mix the contents of the tube by gentle swirling.  The mixture is ready to test.
img/schnelltest/influenza_ab_complete/probenaufbereitung.gif

 

PROCEDURE OF TEST

  1. Remove the test panel from the foil packet, and place it on a flat, dry surface.
  2. Holding the sample dropper above the test panel squeeze 4 drops of the mixed specimen into the sample well (Figure 1). Wait until each drop is absorbed, before adding next drop.  Note: If the drops may contain many air-bubbles, then the actual specimen Volume may be less than the minimum volume required. So if there is no red-dye migration to the Result Window in about 30 seconds, add additional drop or drops.
  3. As the test begins to work, you will see purple color move across the Result Window in the center of the test panel.
  4. Interpret test results at 10 minutes. Do not interpret test results after 15 minutes.

Caution: The above interpretation time is based on reading the test results at room temperature of 15 to 30 oC.  If your room temperature is significantly lower than 15 oC, then the interpretation time should be properly increased.
 

INTERPRETATION OF THE TEST

  1. A color band will appear at the left section of the Result Window to show that the test is working properly. This band is the Control Band.
  2. The right section of the Result Window indicates the test results. If another color band appears at the right section of the Result Window, this band is the Test Band.
img/schnelltest/influenza_ab_complete/auswertung.gif



POSITIVE RESULT: TWO COLO BANDS
The presence of two color bands ("T" band and "C" band) within the result window regardless of which band appears first indicates a positive result in either or both Inf-A/Inf-B panel, indicating positive for Inf-A and/or Inf-B respectively (Figure 2, 3 and 4).  Note: Generally, the higher the analyte level in the specimen, the stronger the "T" band color will be.  When the specimen analyte level is close to but still within the sensitivity limit of the test, the color of the "T" band will be very faint.

NEGATIVE RESULT: ONE COLOR BAND
The presence of only one color band within the Result Window indicates a negative result (Figure 5).

INVALID RESULT:
If after performing the test, no color bands are visible within the Result Window, the result is considered invalid. Some causes of invalid results are: not following the directions correctly or the test may have deteriorated beyond the expiration date. It is recommended that the specimen be re-tested using a new test kit (Figure 6 and 7).

Note: A positive result will not change once it has been established at 15 minutes.  However, in order to prevent any incorrect results, the test result should not be interpreted after 15 minutes.

USER QUALITY CONTROL
Control standards are not supplied with this kit; however, it is recommended that a control be tested as good laboratory testing practice.

LIMITATIONS OF THE TEST
Although the Keul-o-test Influenza A/B Complete is accurate in detecting Influenza A/B viurs, false results can occur. Other clinically available tests are required if questionable results are obtained. The Keul-o-test Influenza A/B Complete is qualitative assay.  The amount of Influenza A or B present in the specimen cannot be estimated by the assay. The assay results distinguish positive from negative samples only. As with all diagnostic tests, a definitive clinical diagnosis should not be based on the results of a single test, but should only be made by the physician after all clinical and laboratory findings have been evaluated.

SENSITIVITY AND SPECIFICITY:
This test is compared against RT-PCR for it's relative sensitivity and specificity: The RT-PCR relative Sensitivity/Specificity of Keul-o-test Influenza A/B Complete is 84.4%/94.7% for A strains and 84.3%/95.5% for B strains.

Sensitivity testing of the Keul-o-test Influenza A/B Complete in comparison with viral culture and  test (n = 300).
 

 Culture 
+-
Keul-o-test Influenza A/B Complete+11412126
-36138174
 150150300
76%92% 
SensitivitySpecificity

 

Relative sensitivity of Keul-o-test Influenza A in comparison with viral Culture.

 Culture Flu-A 
+-
Keul-o-test Influenza A+10312115
-32138170
 135150285
76.3%92% 
SensitivitySpecificity

 

Relative sensitivity of Keul-o-test Influenza A in comparison with RT-PCR.

 RT-PCR (Taqman) 
+-
Keul-o-test Influenza A+1148122
-21142159
 135150285
84.4%94.7% 
SensitivitySpecificity

 

Relative sensitivity of Keul-o-test Influenza B  in comparison with RT-PCR

 

 RT-PCR (Taqman) 
+-
Keul-o-test Influenza B+27229
-54247
 324476
84.3%95.5% 
SensitivitySpecificity
 

 


Sensitivity (Analytical Sensitivity)
Virus titration in embryonated chicken eggs is used to determine Analytical Sensitivity

Viral Strain

Type

Subtype

CEID/Test

Texas 1/77

A

H3N2

2.9 x 103

HongKong/8/68

A

H3N2

6.1 x 101

Shanghai/11

A

H3N2

6.1 x 101

Port Chalmers

A

H3N2

1.25 x102

New Jersey/8/76

A (Swine)

H1N1

2.5 x 102

NWS/33

A

H1N1

1.24 x 103

Mal/302/54

A

H1N1

6.73 x 103

HongKong/5/72

B

N/A

3.6 x 101

Taiwan

B

N/A

3.6 x 102

California

B

N/A

3.1 x 103

Stockholm

B

N/A

3.6 x 105

In addition, the Keul-o-test Influenza A/B Complete have been shown to detect the all the strains examined:

H2N2 - A/Hokkaido 17/01 (Duck)
H3N8 - A/ Monogolia/3/03 (Duck)
H5N1 - A/HongKong/156/97
H5N1 - A/Yamaguchi/7/04 (Chicken)
H5N1 - A/Thailand/MK2/04
H6H2 - A/Massachusett/3740/65 (Turkey)
H7N7 - A/Massachusetts/1/80 (Seal)
H9N2 - A/Wisconsin/66 (Turkey)

REFERENCES:

  1. Murphy, B.R., and R.G. Webster, 1996, Orthomyxoviruses, pp. 1397-1445. In: Fields, Virology, 3rd edition, B.N. Fields, D.M. Knipe, P.M. Howley, et al. (eds.), Lippincott-Raven, Philadelphia.
  2. Biosafety in Microbiological and Biomedical Laboratories, 4th Edition. U.S.Department of Health and Human Services, CDC, NIH, Washington, DC (1999).
  3. CDC website: http://www.cdc.gov/flu/

Abrechnung

 Nr.
Preis in €

GOÄ-
GKV Patienten mit Selbstzahlungsleistung
(IGel) einfacher Satz

4644
16,76

img/page/needfull/Tabelle-unten1.jpg

img/page/needfull/ce-zeichen.gif Manufacturer:

Guenter Keul GmbH
Günter Keul GmbH
Von-Langen-Weg 10
D-48565 Steinfurt
Tel.: 02551/2097  Fax.: 02551/80883
Web: www.keul.de

(akt. 22.09.2015)

 
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