產(chǎn)品說明：
產(chǎn)品優(yōu)勢：
1.一卡雙測，一滴血即可檢測IGG/IGM兩個(gè)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(shù)、獨(dú)特稀釋提高產(chǎn)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(yù)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(yàn)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(jìn)行檢測，結(jié)合墊上含有膠體金標(biāo)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(zhì)控線(C線)是由位于結(jié)合墊上含有膠體金標(biāo)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(jīng)結(jié)合墊首先與金標(biāo)記重組新型冠狀病毒抗原結(jié)合，然后繼續(xù)移動(dòng)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(fù)合物，并在檢測線出現(xiàn)紅色條帶。同時(shí)，結(jié)合墊上的金標(biāo)記兔IgG與硝酸纖維素膜上的羊抗兔IgG抗體結(jié)合呈紅色質(zhì)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(chǎn)品性能指標(biāo)】
1.經(jīng)過一個(gè)獨(dú)立臨床實(shí)驗(yàn)室評(píng)價(jià)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(dá)到91.4%特異性達(dá)到 97.1% 。
2.我們實(shí)驗(yàn)室評(píng)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(gè)陽性質(zhì)控品，陽性率達(dá)到 100%，檢測200個(gè)健康人血清，陰性率達(dá)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(qǐng)?jiān)敿?xì)閱讀說明書，將檢測盒和樣本恢復(fù)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(tái)面上并按樣本編號(hào)。
3．取一個(gè)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(nèi)加入60μl混勻后液體，開始計(jì)時(shí)。
5．等待1-20分鐘，直到測試線顯示為紅色并將結(jié)果記錄為陽性。 如果測試線在20分鐘時(shí)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(chǔ)存條件
Room temperature 4-30 ℃, storage for 12 months （室內(nèi)溫度4-30度，保質(zhì)期12個(gè)月）
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