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COVID-19 Ag Detection Kit  [CE-IVD](ANVISA)(Cat#41A254)

COVID-19 Ag Detection Kit [CE-IVD](ANVISA)(Cat#41A254)

SKU: 41A254

 

CE Marking: NL-CA002-2021-59065

with European CE and Brazilian ANVISA approval for IVD-use

 

Download instrction PDF★

★說明書下載★

 

REAGENTS AND MATERIALS

  • COVID-19 Ag strip 
  • Sample lysis buffer
  • Swabs 
  • Product Insert

 

試劑盒組成

  • COVID-19 Ag 檢測卡
  • 裂解液
  • 鼻拭子 
  • 使用說明書

​​​​​

  • INTENDED USE

    COVID-19 Ag Detection Kit (Colloidal Gold Immunochromatography) is a lateral flow antigen rapid diagnostic test that uses highly specific monoclonal antibodies to qualitatively detect SARS-CoV-2 Nucleocapsid protein (NP) from nasopharyngeal/nasal or oropharyngeal samples of individuals suspected of COVID-19, including delta and omicron and delta variants.This test is intended for a Point-of-Care setting.

    For professional use only

  • 產品用途

    英諾診斷新冠病毒抗原快速檢測試劑盒是一款體外診斷測試工具,可以用來檢測疑似新冠感染患者鼻拭子上的新冠抗原,包括Omicro 及Delta等新冠變種。

  • TEST PROCEDURE

    1. Carefully insert the swab into the user’s nostril. The swab tip should inserted up to 1 inch (2.5 cm) form 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. Open the extraction tube and insert the swab into an extraction tube.

    5. While squeezing the tube, stir the swab more than 5 times and wait for 1 minute.

    6. Squeeze the wall of the tube to extract the liquid from the swab.

    7. Remove the swab and screw the nozzle cap tightly onto the tube.

    8. Open the pouch and remove the strip.

    9. Invert the extraction tube and add 3 drops (~80 μL) of the extracted specimen to the specimen well (S).

    10. Read the test result at 15 minutes.

  • 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,在另一個鼻孔中重複相同動作。

    3.從鼻腔中取出棉籤。

    4. 旋開裂解管的紫色蓋子,將鼻拭子浸到裂解液中,並轉動超過5次,讓鼻拭子在裂解液中靜置一分鐘。

    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. 扭緊蓋子。

    7. 撕開檢測卡包裝,將檢測卡放平。

    8. 擰開抽提管上的白色蓋子,露出滴頭。

    9. 把抽提管垂直置於檢測卡樣品口上方,擠出3滴溶液到樣品口里(S)

    10. 置於室溫15分鐘後(不可多於20分鐘),查看測試結果。

  • INTERPRETATION OF TEST RESULTS

    Positive: 

    The presence of two lines as the control line (C) and the test line (T) in the result window.

    Negative:

    The presence of a single line as the control line (C) in the result window.

    Invalid: 

    If the control line (C) is not visible within the result window after performing the test, the result is invalid.

     

  • 結果解讀

    陽性: 在C和T區域內分別顯示一條線,檢測到新冠抗原,表明您目前處於被新冠病毒感染的狀態。

    陰性: 只在C區域內顯示一條線,未檢測到新冠抗原。

    無效: 在C區域內沒有顯示一條線,此結果無效,請使用新的檢測卡再檢測一次。

  • 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

  • PUBLICATIONS CITING THIS PRODUCT

    1. Krashias G, Deeba E, Constantinou A, Hadjiagapiou M, Koptides D, Richter J, Tryfonos C, Bashiardes S, Lambrianides A, Loizidou MA, Hadjisavvas A, Panayiotidis MI, Christodoulou C. Characterization of IgG Antibody Response against SARS-CoV-2 (COVID-19) in the Cypriot Population. Microorganisms. 2021 Dec 31;10(1):85.
    2. Kaul D, Gujral K. Perinatal transmission of SARS-CoV-2 antibodies and the risk of infection. Current Medicine Research and Practice. 2021 Feb; 11(4): 192-194.
PriceFrom $5.00

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