產品說明：
產品優勢：
1.一卡雙測，一滴血即可檢測IGG/IGM兩個抗體；
2快速檢測，從血液樣本采集到檢測完畢僅需20分鐘；
3全能抗原捕捉技術、獨特稀釋提高產品靈敏度；
Product advantages:
1. One card double test, one drop of blood can detect IgG / IgM two antibodies;
2. Rapid detection, from the blood sample collection to the end of detection only takes 20 minutes;
3. all-round antigen capture technology、Unique dilution will be more than sensitivity,
【預期用途】
本試劑盒用于體外定性檢測人血清、血漿或全血樣本中新型冠狀病（COVID-19）IgG/IgM抗體。
Intended use
This product is used for the qualitative detection of SARS-CoV-2 (COVID-19) IgM and IgG Antibodies in human serum, plasma, whole blood or fingertip blood
【檢驗原理】
本試劑卡工作原理：本試劑盒為膠體金免疫層析試劑盒，用于定性檢測人血清、血漿、全血或指端血中抗新型冠狀病毒（2019-nCoV）IgG/IgM抗體。采用抗原-抗體夾心一步法進行檢測，結合墊上含有膠體金標記重組新型冠狀病毒抗原，硝酸纖維素膜上分別包被有鼠抗人IgG抗體（檢測線，G線）、鼠抗人IgM抗體（檢測線，M線）。質控線(C線)是由位于結合墊上含有膠體金標記兔IgG和包被于硝酸纖維素膜上的羊抗兔IgG抗體組成。樣本中的抗新型冠狀病毒IgM或IgG抗體流經結合墊首先與金標記重組新型冠狀病毒抗原結合，然后繼續移動并與包被固定在硝酸纖維素膜上鼠抗人IgM抗體（M線）或鼠抗人IgG抗體（G線）形成免疫復合物，并在檢測線出現紅色條帶。同時，結合墊上的金標記兔IgG與硝酸纖維素膜上的羊抗兔IgG抗體結合呈紅色質控線（C線）條帶。
Principle
This kit is a colloidal gold immunochromatographic testing product for the qualitative determination of IgM and IgG antibodies against novel coronavirus (COVID-19) in human serum, plasma, whole blood or fingertip blood. Antibody-antigen sandwich onestep assay has been used in this detection. For the test line (M line and G line), colloidal gold conjugated COVID-19 antigen is used as a detector and coated on the conjugate pad, and mouse anti-human IgM antibody and mouse anti-human IgG antibody are used as the two captures and coated separately on nitrocellulose membrane. For the quality control line (C-line), colloidal gold conjugated rabbit IgG is used as a detector and coated on the conjugate pad and goat antirabbit IgG antibody is used as the capture and coated on nitrocellulose membrane. When a sample is loaded on the conjugate pad, the IgM or IgG antibody against the virus antigen in the sample specifically binds to the virus antigen that is conjugated with gold, forms an IgM or IgG antibody-antigen gold complex, then the complex migrates on the nitrocellulose membrane and is captured by mouse anti-human IgM or IgG antibodyand immobilized on the nitrocellulose membrane, and then red bands appear on the detection line (M line and G line). The gold labeled rabbit IgG is captured by goat anti rabbit IgG antibody and forms a red quality control line (C line) on the nitrocellulose membrane at the same time.
【產品性能指標】
1.經過一個獨立臨床實驗室評價顯示，新型冠狀病毒(COVID-19) IgG/ IgM抗體檢測試劑盒(膠體金法)與熒光RT-PCR方法相比較，靈敏度達到91.4%特異性達到 97.1% 。
2.我們實驗室評估新型冠狀病毒(COVID-19) IgG/ IgM抗體檢測試劑盒(膠體金法）檢測20個陽性質控品，陽性率達到 100%，檢測200個健康人血清，陰性率達到99%。
[Performance characteristics]
1.Tests evaluated by an independent clinical laboratory showed that Novel Coronavirus (COVID-19) IgG/IgM Antibody Test Kit (Colloidal Gold) gave 91.4% of
sensitivity and 97.1% of specificity compared to fluorescence RT-PCR assay.
2. Tests evaluated in our laboratory showed that Novel Coronavirus (COVID-19) IgG/IgM Antibody Test Kit (Colloidal Gold) gave 100% positive response in 20 of the positive control and 99% negative response in 200 of health human serum samples.
【檢測方法】
1．使用前請詳細閱讀說明書，將檢測盒和樣本恢復至室溫。
2．沿鋁箔袋切口部位撕開，取出試劑盒放置于水平臺面上并按樣本編號。
3．取一個稀釋液管，加入5微升血清、血漿或全血樣本，混勻。
4．向檢測卡的加樣孔內加入60μl混勻后液體，開始計時。
5．等待1-20分鐘，直到測試線顯示為紅色并將結果記錄為陽性。 如果測試線在20分鐘時沒有顯示為紅色，則記錄為陰性
[Testing procedure]
1.Read the instruction carefully before using the test kit,and restore the test kit and sample to room temperature.
2.Take out the test card from the foil bag, put it on the level table and mark it;
3.Add 5μl serum or plasma sample or whole blood sample into the dilution buffer tube and turn upon & down to mix it, and then transfer 60μl into the sample well of the card with dispette or pipette, start timing;
4.Wait for 1-15 minutes until the test line appear as red and record the result as a positive. If the test line does not appear as red at 15 minutes, it is recorded as a negative.
Storage method儲存條件
Room temperature 4-30 ℃, storage for 12 months （室內溫度4-30度，保質期12個月）
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