Τεστ Διάγνωσης Γρίπης Αντιγόνα Α/Β Influenza A & B Ag One Step Rapid Test Healgen Σετ 20τμχ.
Το τεστ Διάγνωσης Γρίπης Rapid Influenza Healgen είναι ένας in vitro ανοσοχρωματογραφικός προσδιορισμός για την ποιοτική ανίχνευση των αντιγόνων της γρίπης Α (συμπεριλαμβανομένου του υποτύπου H1N1) και της νουκλεοπρωτεΐνης Β σε ρινοφαρυγγικό (NP) στυλεό, ρινικό σπόνδυλο και ρινικά δείγματα πλύσης / αναρρόφησης. Προορίζεται να βοηθήσει στην ταχεία διαφορική διάγνωση των ιικών λοιμώξεων της γρίπης Α και Β.
- Υψηλή ευαισθησία.
- Υψηλή ακρίβεια
- Εύκολο στη χρήση.
- Δείγμα από ρινική βλέννα ή σάλιο.
- Δείτε τα αποτελέσματα μέσα σε 10 λεπτά.
- Μεμονωμένο πακέτο, εύκολο στη χρήση.
- Ακρίβεια πάνω από 99%.
- Εγγύηση 2 έτη.
Το κάθε τεστ περιλαμβάνει:
- 20 Συσκευές δοκιμής Influenza A & B Ag.
- 20 Αποστειρωμένα μαντηλάκια.
- 20 Σωλήνες εκχύλισης.
- 1 Σταθμό εργασίας
- 2 Δοχεία διαλύματος 7ml.
Specimen Collection
It is applicable to the diagnosis of the influenza virus A and B from the samples of nasal swabs,throat swabs or nasal aspirates. Use freshly collected samples for optimal test performance.Inadequate sample collection or improper sample handling may yield a false-negative result.
Test Procedure
Allow the test device, test sample and extraction buffer to equilibrate to room temperature (15-30°C) prior to testing.
1. Remove test device from the sealed pouch just prior to the testing and lay flat on work bench.
2. Insert a nozzle with filter into the sample extraction tube tightly.
3. Reverse the sample extraction tube, and add 4 drops (about 120 -150 µl) of test sample by squeezing the extracted solution tube into the sample window.
4. Wait for the colored band(s) to appear. The result should be read in10 minutes. Do not interpret the result after 10 minutes.
Interpretation Of Results
• POSITIVE
1 Flu A Positive:The presence of two lines as control line (C) and A test line within the result window indicates a positive result for Influenza A viral antigen.
2 Flu B Positive:The presence of two lines as control line (C) and B test line within the result window indicates a positive result for Influenza B viral antigen.
3 Flu A+B Positive:The presence of three lines as control line (C), A test line and B test line within the result window indicates a positive result for Influenza A and Influenza B viral antigen.
• NEGATIVE
The presence of only control band (C) within the result window indicates a negative result.
• INVALID
If the control band (C) is not visible within the result window after performing the test, the result is considered invalid. Some causes of invalid results are because of 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.
Performance characteristics
1. Analytical Sensitivity
The minimum detection limit is 1.5 x 104 TCID50/test for the Influenza A virus antigen and is 1.5 x 105 TCID50/test for the Influenza B virus antigen.
2. Analytical Reactivity
The influenza A strain listed tested positive in the Influenza A&B Ag Rapid Test. Although the specific influenza strains causing infection in human can very, all contain the conserved nucleoproteins targeted by Influenza A&B Ag Rapid Test.
| Strains | Sources | Subtypes | Concentration |
| Flu A/Hubei/PR8/2001 | Human | H1N1 | 1.8×10 4 TCID 50/test |
| Flu A/New Kaledonia/20/99 | Human | H1N1 | 1.8×10 4 TCID 50/test |
| Flu A/Yamagata/32/89 | Human | H1N1 | 1.8×10 4 TCID 50/test |
| Flu A/Beijing/262/95 | Human | H1N1 | 1.8×10 4 TCID 50/test |
| Flu A/Singapore/1/57 | Human | H2N2 | 3.0×10 4 TCID 50/test |
| Flu A/Hubei/3/2005 | Human | H3N2 | 3.0×10 4 TCID 50/test |
| Flu A/Akita/1/94 | Human | H3N2 | 3.0×10 4 TCID 50/test |
| Flu A/Kita Kyusyu/159/93 | Human | H3N2 | 3.0×10 4 TCID 50/test |
| Flu A/Iowa/15/30 | Swine | H1N1 | 3.0×10 4 TCID 50/test |
| Flu A/Hongkong/168/93 | Swine | H1N1 | 3.0×10 4 TCID 50/test |
| Flu A/Anhui/24/2004 | Swine | H5N1 | 6.0×10 4 TCID 50/test |
| Flu A/Hubei/134/2000 | Swine | H9N2 | 6.0×10 5 TCID 50/test |
| Flu A/Hubei/251/2001 | Swine | H9N2 | 6.0×10 5 TCID 50/test |
| Flu A/Yuyao/1/2006 | Chicken | H5N1 | 6.0×10 4 TCID 50/test |
| Flu A/Yuyao/2/2006 | Chicken | H5N1 | 6.0×10 4 TCID 50/test |
| Flu A/Jiangsu/2/2004 | Chicken | H5N1 | 6.0×10 4 TCID 50/test |
| Flu A/Hubei/216/83 | Duck | H7N8 | 3.0×10 5 TCID 50/test |
| Flu A/Hubei/118/2003 | Duck | H9N2 | 1.5×10 5 TCID 50/test |
| Flu A/Hubei/155/2003 | Duck | H9N2 | 6.0×10 5 TCID 50/test |
| Flu A/Hubei/137/1982 | Duck | H10N4 | 3.0×10 5 TCID 50/test |
| Flu A/Singapore/3/97 | Duck | H5N3 | 6.0×10 4 TCID 50/test |
| Flu A/Henan/1/2004 | Tree sparrow | H5N1 | 6.0×10 5 TCID 50/test |
| Flu A/Henan/2/2004 | Tree sparrow | H5N1 | 3.0×10 5 TCID 50/test |
| Flu A/Henan/4/2004 | Tree sparrow | H5N1 | 6.0×10 4 TCID 50/test |
| Flu A/Wisconsin/66 | Turkey | H9N2 | 6.0×10 4 TCID 50/test |
| Flu A/England/1/63 | Turkey | H7N3 | 6.0×10 4 TCID 50/test |
| Flu A/Singapore/1/57 | Bird | H5N1 | 6.0×10 4 TCID 50/test |
| Flu A/Hunan/71/2004 | Bird | H5N1 | 6.0×10 4 TCID 50/test |
| Flu A/Shanxi/50/2006 | Bird | H5N1 | 6.0×10 4 TCID 50/test |
| Flu A/Shanxi/42/2006 | Bird | H5N1 | 6.0×10 4 TCID 50/test |
| Flu A/Fujian/320/2004 | Bird | H5N1 | 3.0×10 5 TCID 50/test |
Influenza A&B Ag Rapid Test can detect all nine influenza B strains.
3. Clinical Study Data Summary
The Influenza A&B Ag Rapid Test performance vs. Cell Culture
| Kind of samples | Type | Sensitivity(%) | Specificity(%) | Accuracy(%) |
| Nasal Swab | A | 92.6 (25/27) | 96.4 (81/84) | 95.5 (106/111) |
| B | 90.0 (27/30) | 95.8 (91/95) | 94.4 (118/125) | |
| Throat Swab | A | 83.3 (20/24) | 95.2 (59/62) | 91.9 (79/86) |
| B | 82.6 (19/23) | 91.8 (67/73) | 89.6 (86/96) | |
| Nasal Aspirate | A | 88.9 (48/54) | 93.3 (125/134) | 92.0 (173/188) |
| B | 91.2 (52/57) | 95.4 (98/103) | 93.8 (150/160) | |
| Nasal discharge/Nasal mucus | A | 80.7 (46/57) | 94.9 (93/98) | 89.7 (139/155) |
| B | 89.6 (62/69) | 94.6 (87/92) | 92.5 (149/161) |
4. Analytical Specificity And Cross-reactivity
The Influenza A&B Ag Rapid Test was evaluated with a total of 30 bacterial and viral isolates. Bacterial isolates were evaluated at a concentration between 107 and 109 org/mL. Viral isolates were evaluated at a concentration of at least 104 – 108 TCID50/mL. Adenovirus 18 and Parainfluenza virus 3 were tested at 102 TCID50/mL. None of the organisms or viruses listed below gave a positive result in the Influenza A&B Ag Rapid Test.
5. Interfering Substances
Whole blood, and several over-the-counter (OTC) products and common chemicals were evaluated and did not interfere with the Influenza A&B Ag Rapid Test at the levels tested: whole blood (2%); three OTC mouthwashes (25%); three OTC throat drops (25%); three OTC nasal sprays (10%); 4-Acetamidophenol (10 mg/mL); Acetylsalicylic Acid (20 mg/mL); Chlorpheniramine (5 mg/mL); Dextromethorphan (10 mg/mL); Diphenhydramine (5 mg/mL); Ephedrine (20 mg/mL); Guaiacol glyceryl ether (20 mg/mL); Oxymetazoline (10 mg/mL); Phenylephrine (100 mg/mL); and Phenylpropanolamine (20 mg/mL).
