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【Test Procedure】
1)Preparation of Sample
Add 0.5 ml of the sample extraction buffer into the test tube which is supplied in this kit, and put on the stand.
①Nasal Aspirate
Add 0.5 ml of the nasal aspirate fluid into transfer buffer or 2 ml of the buffered saline. Add 0.5 ml of this mixture to the extraction tube which contains 0.5 ml of the extraction buffer (up to 1 ml memory line), and mix well by squeezing.
②Swabs of Nasal or Throat
Add the swab which has been used to collect the sample into the extraction tube, which was previously added with 0.5 ml of extraction buffer. After mixing, squeezing the tube several times with fingers from outside of the tube to immerse the swab. Remove the swab. The extracted solution will be used as test sample.
2)Procedure
① Insert a nozzle (which has filter with it) into the sample extraction tube tightly.
② Reverse the extraction tube, and add 3 drops (about 100 μL) by squeezing of the extracted solution on the sample window.
③ Make judgment after 15 min following the criteria described below:
3)Judgment Criteria
Abbreviated. ※
【Effectiveness Calibration】
—Capilia (R)Flu A—
To use the following control to calibrate the test plate: Positive Control (3.0~3.9×105 TCID50 / Test*1),Weak Positive Control(3.0~3.9×104 TCID50 / Test; Negative control (sample extraction buffer)
—Capilia (R)Flu B—
To use the following control to calibrate the test plate: Positive Control(1.5~1.9×106 TCID50 / Test),Weak Positive Control(1.5~1.9×105 TCID50 / Test; Negative control (sample extraction buffer).
Detection Range
Minimal detection limit for Capilia FluA is 3.0×104 TCID50 / Test。
Minimal detection limit for Capilia FluB is1.5×105 TCID50 / Test。
5)Cross Reaction Test Results※
—Capilia (R)Flu A—
①Influenza A strains
Subtype of H1N1:5 strains、H2N2:3 strains、H3N2:7 strains,All are positive。
②Influenza B strain
No cross reaction with 9 Influenza B strains.
—Capilia (R)Flu B—
①Influenza B strain
Positive for all the 9 Influenza B virus。
②Influenza A strain
No cross reaction with the 5 strains of Subtype of H1N1, 3 strains of H2N2 and 7 strains of H3N2.
—Capilia (R)Flu A,B—
No cross reaction with following pathogens
①Virus other than influenza:
Adenovirus Type 1~8,11,19,37, Coxsackie virus Type A16,B1~5, Cytomegalovirus, Echovirus Type 3,6,9,11,14,18,30, Enterovirus Type 71, HSV-1, Mumps virus, Parainfluenza virus Type 1~3, Poliovirus Type 1~3, Respiratory syncytial virus, Rhinovirus Type 1A,13,14
②Mycoplasma etc.
No cross reaction with Chlamydia pneumoniae, Chlamydia psittaci, Chlamydia trachomatis, Mycoplasma pneumoniae。
③Bacteria
No cross reaction with following bacteria:
Acinetobacter baumannii, Bacteroides fragilis, Bordetella pertussis, Candida albicans, Candida glabrata, Cardiobacterium hominis, EikeneUa corrodens, Enterococcus gallinarum. Escherichia coil, Haemophilus phrophlus, aemophilus infiuenzae, Haemophilus parainfluenzae, Haemophilus paraphrophilus, Kingella kingae, Klebsiella pneumoniae, Listeria monocytogenes, Moraxella catarrhalis, Neisseria gonorrhoeae Proteus mirabilis, Proteus vulgaris, Pseudomonas aeruginosa, Serratia marcescens, Staphylococcus aureus, Staphylococcus epidermidis, Streptococcus pneumoniae, Streptococcus, pyogenes, Streptococcus agalactiae, Streptococcus sp. group C, G, F, Streptococcus mutans
6)Clinial Test Data Summary
—Capilia (R)Flu A—
①Nasal Aspirates |
| |
Capilia Flu A |
Positive |
Negative |
Total |
Culture |
Positive |
139 |
10 |
149 |
Negative |
14 |
414 |
428 |
Total |
153 |
424 |
577 |
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Sensitivity = 139/149×100%=93.3%
Specificity = 414/428×100%=96.7% |
②Nasal Swab
| |
Capilia Flu A |
Positive |
Negative |
Total |
Culture |
Positive |
41 |
3 |
44 |
Negative |
276 |
12 |
284 |
Total |
317 |
15 |
328 |
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Sensitivity=41/44=93.2%
Specificity=276/284×100%=97.2% |
③Throat Swab
| |
Capilia Flu A |
Positive |
Negative |
Total |
Culture |
Positive |
28 |
5 |
33 |
Negative |
8 |
159 |
167 |
Total |
36 |
164 |
200 |
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Sensitivity=28/33×100%=84.6%
Specificity=159/167×100%=95.2% |
—Capilia(R)Flu B—
| |
Capilia Flu B |
Positive |
Negative |
Total |
Culture |
Positive |
103 |
23 |
126 |
Negative |
31 |
1115 |
1146 |
Total |
134 |
1138 |
1272 |
|
Sensitivity=81.7%
Specificity=97.3% |
| |
Capilia Flu B |
Positive |
Negative |
Total |
Culture |
Positive |
239 |
27 |
266 |
Negative |
31 |
1145 |
1176 |
Total |
270 |
1172 |
1442 |
|
Sensitivity=89.8%
Specificity=97.4% |
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