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careUS™ Influenza A & B Dipstick

careUS™ Influenza A & B Dipstick

careUS™ Influenza A & B Dipstick

Product catalog summary
Product Overview:
careUS™ Influenza A & B is a qualitative rapid diagnostic test designed for the detection of all subtypes of human influenza A, including the 2009 H1N1 pandemic strain, and influenza B viral antigens. The test is performed using nasopharyngeal swab specimens and provides results in 10-15 minutes.
Features:
  • Distinguishes between influenza A and B viruses.
  • Fast and simple procedure with easy-to-read results.
  • Test results are indicated by three distinct lines.
Test Procedure:
  1. Collect a nasopharyngeal swab specimen by inserting the swab into one nostril and reaching the nasopharynx.
  2. Place the swab into an extraction vial, rotate it five times, and remove it while rolling the swab head against the vial.
  3. Insert the test strip into the extraction vial.
  4. Read the result at 10 minutes; do not read after 15 minutes.
Interpretation of Results:
  • Negative: No influenza detected.
  • Positive Type A: Influenza A detected.
  • Positive Type B: Influenza B detected.
  • Positive Type A & B: Both influenza A and B detected.
  • Invalid: Test result is not valid.
Clinical Performance:
  • Sensitivity for Flu A: 70.1% [95% CI: 59.2%-79.2%]
  • Sensitivity for Flu B: 64.7% [95% CI: 52.8%-75.0%]
  • Specificity: 100% [95% CI: 97.3%-100.0%]
  • Reference Assay: Real-time PCR
Packaging Information:
  • Product Cat. No.: RFL-M02582
  • Package Size: 25 tests per box
  • Components: Test strips, extraction vials, NP swabs, positive and negative control swabs, instructions for use.
Related Products:
  • careUSTM RSV
  • careUSTM Strep A
  • careSTARTTM Lite - G (RDT Reader)
careSTARTTM Lite - G Features:
  • Portable and lightweight with high sensitivity and reproducibility.
  • User-friendly software with a touch screen.
  • CMOS Image Sensor with storage capacity for 2,000 results.
  • Dimensions: 140(W) x 190(D) x 80(H) mm, Weight: 0.7 kg, Display: 3.5” color LCD screen.
Contact Information:
WELLS BIO, INC., 16, Magokjungang 8-ro 1-gil, Gangseo-gu, Seoul, 07795, Republic of Korea. Tel: +82-2-3660-6900, Email: [email protected]
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Catalog excerpts

careUS™ Influenza A & B Dipstick-1

Influenza is a highly contagious viral infection of the nose, throat, and lungs that occurs most often in the late fall, winter, and early spring. Since other viruses can cause respiratory illness similar to the flu, it is critical to properly diagnose influenza viral infection before any treatment. careUS™ Influenza A & B is intended for the qualitative detection of all subtypes of human influenza A, including 2009 H1N1 pdm, and/or B viral antigens directly from nasopharyngeal swab specimens. • Distinction between influenza A and B virus • Easy-to-read 3 distinct lines MFDS licensed

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careUS™ Influenza A & B Dipstick-2

Test Procedure Method of Sample Collection: Nasopharyngeal swab • Insert swab into one nostril straight back and back to the nasopharynx and leave in place for a few seconds.• Slowly withdraw swab with a rotating motion. 3 Place the test strip into the extraction vial. 1 Place the swab specimen into extraction vial and rotate the swab at least five times. 2 Remove the swab while rolling the swab head against the inside of the extraction vial. 4 Read result at 10 minutes. Do not read the result after 15 minutes. Interpretation of Test ResultsInvalidPositive ABC Negative Packaging Information Product...

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careUS™ Influenza A & B Dipstick-3

Fast and simple differential detection of influenza A & B virusClinical PerformancecareUSTM Influenza A & B / Commercial product VS Real-time PCR • Nasopharyngeal swab used (n=281) * Reference Assay: Real-time PCR careSTART™ Lite - G (RDT Reader)For analysis of careUS™ respiratory disease RDTs • Portable & light weight • High sensitivity and reproducibility • User friendly software with touch screen

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careUS™ Influenza A & B Dipstick-4

Lite - G careSTARTTM Lite - G is an excellent tool for qualitative analysis for the careUSTM Influenza A & B Related Products careUSTM Influenza A & B RSV Strep A Put a test strip into the disposable strip tray Place a strip tray into the Lite - G reader Test Result. e-mail: [email protected]

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*Prices are pre-tax. They exclude delivery charges and customs duties and do not include additional charges for installation or activation options. Prices are indicative only and may vary by country, with changes to the cost of raw materials and exchange rates.
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