Capilia Flu Rapid Diagnostic Test Kit


 
 

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 coilHaemophilus 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

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

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

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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