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Rapid SARS-CoV-2 Antigen Test [Self-test] (Cat#BDT-19)

Rapid SARS-CoV-2 Antigen Test [Self-test] (Cat#BDT-19)

(香港研發，國內GMP廠房生產)
Cat#BDT-19
EC Certificate NO.1434-IVDD-521/2021
德國權威機構臨床驗證；欧盟自檢認證✓
 
★Download instruction PDF★
★說明書下載★
Clinical performance
  • The sensitivity was 90% .
  • The specificity was 99.752%. 
  • The accuracy was 96.523%. 
臨床表現
  • 靈敏度為90% 
  • 特異性為99.752% 
  • 準確率為96.523% 

  • INTENDED USE

     
    Rapid SARS-CoV-2 Antigen Test Card is for rapid and qualitative detection SARS-CoV-2 virus antigen (including all known variants) in anterior nasal (front nose) swabs of individuals.

  • 產品用途

    SARS-CoV-2 抗原快速檢測試劑盒是用來快速定性地檢測個體前鼻拭子中的SARS-CoV-2病毒抗原。目前，所有已知的 SARS-CoV-2 變種均不影響產品性能。

  • TEST PROCEDURE

    1. Carefully insert the swab into the user's nostril. The swab tip should be inserted up to 2.5cm(1 inch) from the edge of the nostril. 
    2. Dab along the lining of the nostril and roll the swab several times.
    3. Remove the swab from the nasal cavity. 
    4. Add the sample extraction buffer into extraction tube, then place the swab with specimen into the extraction tube. Roll the swab three to five (3-5) times. Leave the swab in the sample extraction buffer for 1 minute.
    ​​​​5. Pinch the extraction tube with fingers and remove the solution from the swab as much as possible.
    6. Install the nozzle cap onto the sample extraction tube tightly. Use extraction solution as test specimen. 
    7. Open the pouch and remove the card. After opening, the test card must be used immediately. 
    8. Invert the extraction tube, and gently squeeze the extraction tube, add 2-3 drops of the test sample into the sample hole (S). 
    9. Read the result at 15-20 minutes.
    Note: The result after 20 minutes may not be accurate.

  • 測試步驟

    1. 頭部向後傾，輕輕將拭子伸入鼻腔，拭子尖端應插入距鼻孔邊緣最多1 英寸（2.5 厘米）的位置。

    2. 沿著鼻孔內壁滾動拭子數次。

    3. 從鼻腔中取出棉籤。

    4.將提取緩衝液加入提取管中，然後將帶有樣本的拭子放入提取管中。將拭子在液體中轉動3-5次，並停留1分鐘。

    5.擠壓管壁，移除拭子的時候盡可能地將液體留在抽提管中。

    6.將噴嘴蓋牢固地蓋在樣品提取管上。

    7.撕開檢測卡包裝，將檢測卡平放。

    8.倒轉提取管，輕輕擠壓提取管，將2-3滴的測試樣品加到樣品孔（S）中。

    9.置於室溫15分鐘後，查看測試結果。

  • INTERPRETATION OF TEST RESULTS

    Positive:​​​​​​
    One ribbon appears in the control zone (C) and the other ribbon appears in the test zone (T). ​​​​​
    Negative:
    Only one ribbon appears in the control zone (C) and there is no ribbon in the test zone (T).
    Invalid result:
    No ribbon shows in the Control Zone (C).

  • 結果解讀

    陽性: 在C和T區域內分別顯示一條線。

    陰性: 只在C區域內顯示一條線，而T區域內未顯示一條線。

    無效: 在C區域內沒有顯示一條線。

  • REMARKS

    For bulk orders, free sample and big discount will be available, please contact us at info@immunodiagnostics.com.hk​​​​​​
     

  • 附註

    批量訂購可提供免費樣品試用，並享受大幅度折扣，請聯系我們info@immunodiagnostics.com.hk

價格自 $5.00

如需批量訂單（數量：5 個或更多），請聯繫我們獲取報價

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