| Quality Certification |
CE |
| Certificate |
CE ISO 13485 |
| Specimen |
Saliva |
| Instrument classification |
Class III |
| Usage |
Professional use and home use |
| Shelf life |
24 Months |
| Accuracy |
More than 99.0% |
| OEM |
Available |
Testsealabs® Influenza A&B Rapid Test Cassette is a rapid chromatographic immunoassay for the qualitative detection of influenza A and B antigens in nasal swab specimens. lt is intended to aid in the rapid differential diagnosis of influenza A and B viral infections.
DIRECTIONS FOR USE
Allow the test, specimen, extraction buffer to equilibrate to room
temperature (15-30°C) prior to testing.
1. Remove the test from the foil pouch and use it as soon as possible.
2. Place the Extraction Tube in the workstation. Hold the extraction
reagent bottle upside down vertically. Squeeze the bottle and let the
solution drop into the extraction tube freely without touching the edge
of the tube. Add 10 drops of solution to the Extraction Tube.
3. Place the swab specimen in the Extraction Tube. Rotate the swab for
approximately 10 seconds while pressing the head against the inside of
the tube to release the antigen in the swab.
4. Remove the swab while squeezing the swab head against the inside of
the Extraction Tube as you remove it to expel as much liquid as possible
from the swab. Discard the swab in accordance with your biohazard
waste disposal protocol.
5. Cover the tube with cap, then add 3 drops of the sample into the sample
hole vertically.
6. Read the result after 15 minutes. If left unread for 20 minutes or more
the results are invalid and a repeat test is recommended.
INTERPRETATION OF RESULTS
POSITIVE Influenza A:* Two distinct colored lines appear. One line
should be in the control line region (C) and another line should be in the
Influenza A region (A). A positive result in the Influenza A region
indicates that Influenza A antigen was detected in the sample.
POSITIVE Influenza B:* Two distinct colored lines appear. One line
should be in the control line region (C) and another line should be in the
Influenza B region (B). A positive result in the Influenza B region
indicates that Influenza B antigen was detected in the sample.
POSITIVE Influenza A and Influenza B: * Three distinct colored
lines appear. One line should be in the control line region (C) and the
other two lines should be in the Influenza A region (A) and Influenza B
region (B). A positive result in the Influenza A region and Influenza B
region indicates that Influenza A antigen and Influenza B antigen were
detected in the sample.
*NOTE: The intensity of the color in the test line regions (A or B) will
vary based on the amount of Flu A or B antigen present in the sample.
So any shade of color in the test regions (A or B) should be considered
positive.
NEGATIVE: One colored line appears in the control line region (C).
No apparent colored line appears in the test line regions (A or B). A
negative result indicates that Influenza A or B antigen is not found in the
sample, or is there but below the detection limit of the test. The patient's
sample should be cultured to make sure that there is no Influenza A or B
infection. If the symptoms do not agree with the results, get another
sample for viral culture.
INVALID: Control line fails to appear. Insufficient specimen volume or
incorrect procedural techniques are the most likely reasons for control
line failure. Review the procedure and repeat the test with a new test. If
the problem persists, discontinue using the test kit immediately and
contact your local distributor.
Hangzhou Testsea Biotechnology Co., LTD. is a national high-tech enterprise, is located in Hangzhou. Testsea has lots of researchers and workers who graduated from Zhejiang University and overseas. Testsea is specialized in the research, development, production and sales of raw materials for medical diagnosis and food safety testing. We have applied for 28 kinds of patents which cover medical diagnosis, food safety rapid testing, food enzymatic immunoassay and new enzyme preparation. Testsea provides perfect raw material solutions for scientific research institutions, enterprises, research institutes and other institutions globally. Testsea total business area is more than 56,000 square meters, including 2,000 square meters of GMP 100,000-level purification workshop, our company is strictly following ISO13485 and ISO9001 quality management system operation with research, production, quality control, finance, domestic sales and international sales, etc. Our products are well accepted by many users domestic and abroad. In addition, we establish a good business relationship with many domestic universities and in vitro diagnostic production enterprises, even with southeast Asia, Europe, Africa, Latin America, and other countries.
Testsea has a research and development team led by doctors and masters with professional workers and a well-equipment facility. The production capacity of recombinant antigens has reached 18g/month.
Testsea pursuit of "integrity, quality, responsibility" concept and adhere to the quality, the purpose of serving the society and constantly developing new high-quality diagnostic materials efforts.
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