流行性腺病毒全套血液檢測(cè)試劑

廣州健侖生物科技有限公司

產(chǎn)品名稱：流行性腺病毒全套血液檢測(cè)試劑，檢測(cè)人血清/血漿抗腺病毒抗體IgG的間接免疫熒光檢測(cè)試劑盒

簡(jiǎn)介：腺病毒是一種重要的呼吸道病原體，可引起兒童肺炎和毛細(xì)支氣管炎。腺病毒感染可通過(guò)三種經(jīng)典方法在實(shí)驗(yàn)室中診斷：臨床標(biāo)本的直接抗原檢測(cè)；培養(yǎng)分離和鑒定病毒的技術(shù)，以及用于檢測(cè)抗體上升的血清學(xué)試驗(yàn)。免疫球蛋白G是主要的抗體類，但有時(shí)IgM檢測(cè)是達(dá)到診斷*的方法。zui廣泛接受的試驗(yàn)是補(bǔ)體結(jié)合（CF）和elisa。IFA試驗(yàn)越來(lái)越多地用于檢測(cè)IgG和IgM。有時(shí)，沒(méi)有血清學(xué)反應(yīng)，但IgM檢測(cè)往往是以達(dá)到診斷的*的方法。

測(cè)試原理：IFA方法是基于樣品中抗體的反應(yīng)，用吸附在滑動(dòng)表面上的抗原進(jìn)行測(cè)試。樣品中的特異性抗體與抗原發(fā)生反應(yīng)，而不與抗原結(jié)合的免疫球蛋白在洗滌步驟中被除去。下一步，抗原抗體復(fù)合物與熒光素標(biāo)記的抗人球蛋白反應(yīng)。它可以用免疫熒光顯微鏡檢查。

試劑盒的特點(diǎn)：除PBS外，所有試劑均已備好使用。所有這些試劑有一個(gè)便于識(shí)別的號(hào)碼。在分析過(guò)程中，每一步使用的試劑的用量都表明了。

試劑盒內(nèi)容（詳情請(qǐng)參考英文原版）：

1 腺病毒幻燈片：幻燈片的腺病毒10的10威爾斯，涂腺病毒感染Hep-2細(xì)胞，腺樣體71株（ATCC VR-1），甲醛處理，丙酮固定和混合與非感染細(xì)胞。

2 PBS：1瓶PBS pH 7.2粉重建與蒸餾水1升。

3腺病毒IgG陽(yáng)性對(duì)照：200µL陽(yáng)性對(duì)照血清，含疊氮鈉。

4腺病毒陰性對(duì)照：陰性對(duì)照血清200µL，含疊氮鈉。

5g抗-人IgG FITC共軛：2瓶1.1毫升的熒光素標(biāo)記的抗人IgG熒光共軛在含Evan´s blue的磷酸鹽緩沖液，疊氮鈉和蛋白質(zhì)穩(wěn)定劑。

6安裝介質(zhì)：安裝介質(zhì)3 mL緩沖甘油，含有疊氮鈉。

所需材料，但不提供：

足夠的精密微量。

經(jīng)恒溫處理孵化器。

蒸餾水。

24x60毫米蓋玻片。

熒光顯微鏡及相應(yīng)的濾光片

´制造商的建議。

潮濕的室

存儲(chǔ)要求：

按建議的溫度存儲(chǔ)。不要使用超過(guò)保質(zhì)期的試劑盒。只有當(dāng)試劑被封上并儲(chǔ)存在的溫度時(shí)，才會(huì)有效。

試劑的穩(wěn)定性和操作：

在無(wú)菌條件下處理試劑以避免微生物污染物。

只使用需要測(cè)試的PBS，控制血清和共軛溶液的數(shù)量。不要把多余的溶液倒進(jìn)瓶子里。重組后，儲(chǔ)存PBS在2-8ºC中，如果有濁度出現(xiàn)，請(qǐng)停止使用。

標(biāo)本采集與處理：

無(wú)菌采集血液必須使用靜脈穿刺技術(shù)。無(wú)菌或無(wú)菌技術(shù)的使用將保持標(biāo)本的完整性。

血清/血漿樣品被冷藏（2-8ºC）在收集或冷凍（20ºC）如果在7天內(nèi)完成測(cè)試，不能。樣品不應(yīng)反復(fù)冷凍和解凍。不要使用高脂血、溶血、污染樣本。含有顆粒的樣品應(yīng)通過(guò)離心澄清。該試劑盒適合于血清或血漿使用。

試劑的初步制備：

只有PBS必須事先準(zhǔn)備好。將小瓶2的含量添加到1升蒸餾水中。搖勻直至*溶解。一旦稀釋，保存在2-8ºC。

局限性：

1、此試劑盒用于與人血清/血漿結(jié)合使用。

2、該工具包的用戶建議仔細(xì)閱讀和理解包插入。為了獲得可靠的測(cè)試結(jié)果，必須嚴(yán)格遵守該協(xié)議。特別是，正確的樣品和試劑的加樣，隨著孵育步驟仔細(xì)清洗和時(shí)機(jī)是*的準(zhǔn)確的結(jié)果。

3、樣品的結(jié)果應(yīng)與臨床評(píng)價(jià)和其他診斷程序結(jié)合使用。隔離技術(shù)應(yīng)作出明確診斷。

4、此測(cè)試不會(huì)顯示感染部位。它并不打算取代孤立。

5、抗體水平的顯著升高并不排除感染可能性。

6、在感染過(guò)程中很早采集的樣本可能沒(méi)有檢測(cè)到IgG水平。在這種情況下，建議進(jìn)行IgM檢測(cè)，或第二次血清樣本，14至21天后，與原樣品平行測(cè)試，以確定血清轉(zhuǎn)換。

7、由于孕婦IgG在分娩前被動(dòng)地從母體傳遞到胎兒，因此必須謹(jǐn)慎地對(duì)其進(jìn)行檢測(cè)。IgM檢測(cè)通常是6個(gè)月以下兒童感染的有用指標(biāo)。

8、單一樣本抗體測(cè)定結(jié)果不應(yīng)用于診斷zui近感染。配對(duì)樣本（急性期和恢復(fù)期）應(yīng)同時(shí)進(jìn)行檢測(cè)，以尋找血清轉(zhuǎn)換或抗體水平顯著上升。

9。自身免疫病患者的樣本在使用IFA時(shí)可能會(huì)對(duì)細(xì)胞產(chǎn)生非特異性反應(yīng)。不能用這種方法對(duì)那些樣品進(jìn)行評(píng)估。

10。性能測(cè)試結(jié)果顯示對(duì)應(yīng)于商業(yè)預(yù)測(cè)設(shè)備的比較研究在一個(gè)確定的人口樣本。小的差異可以發(fā)現(xiàn)，不同群體或不同的預(yù)測(cè)裝置。

更多詳細(xì)說(shuō)明及原版英文說(shuō)明書請(qǐng)工作人員。

【公司名稱】 廣州健侖生物科技有限公司
【】    楊永漢 
【】 
【騰訊 】 2042552662
【公司地址】 廣州清華科技園創(chuàng)新基地番禺石樓鎮(zhèn)創(chuàng)啟路63號(hào)二期2幢101-3室

1 adenovirus slide: slides of adenovirus 10 of 10 Wells, adenovirus-infected Hep-2 cells, adenoid 71 (ATCC VR-1), formaldehyde treatment, acetone fixation and mixed with non-infected cells .

2 PBS: 1 bottle of PBS pH 7.2 powder Reconstituted with distilled water 1 liter.

3 Adenovirus IgG positive control: 200 μL of positive control serum containing sodium azide.

4 adenovirus negative control: negative control serum 200μL, containing sodium azide.

5g anti-human IgG FITC conjugate: 2 vials of 1.1 ml fluorescein-labeled anti-human IgG fluorescently conjugated in Evan's blue-containing phosphate buffer, sodium azide and protein stabilizer.

6 Installation media: Installation media 3 mL buffered glycerol, containing sodium azide.

Required materials but not provided:

Enough precision trace.

Incubate the incubator thermostatically.

Distilled water.

24x60 mm cover glass.

Fluorescence microscope and the corresponding filter

Manufacturer's suggestion.

Wet room

Storage requirements:

Store at the recommended temperature. Do not use kits longer than the shelf life. Reagents are valid only when they are sealed and stored at the specified temperature.

Reagent stability and operation:

Reagents are treated under sterile conditions to avoid microbial contaminants.

Only use the PBS that needs to be tested to control the amount of serum and conjugate solution. Do not pour excess solution into the bottle. After reconstitution, store PBS at 2-8ºC and stop using if turbidity is present.

Specimen collection and processing:

Aseptic blood collection must use venipuncture. The use of sterile or sterile techniques will preserve the integrity of the specimen.

Serum / plasma samples are refrigerated (2-8ºC) during collection or freezing (20ºC) if the test is completed within 7 days. Samples should not be frozen and thawed repeatedly. Do not use hyperlipidemia, hemolysis, contaminated samples. Samples containing particles should be clarified by centrifugation. This kit is suitable for use in serum or plasma.

The initial preparation of reagents:

Only PBS must be prepared in advance. The content of vial 2 is added to 1 liter of distilled water. Shake well until compley dissolved. Once diluted, store at 2-8ºC.

limitation:

1, This kit is used in combination with human serum / plasma.

2, the user of the toolkit recommends reading carefully and understanding package insertion. In order to obtain reliable test results, the agreement must be strictly observed. In particular, the correct sample and reagent loading, with careful cleaning and timing of the incubation steps, is an essential and accurate result.

3, the results of the sample should be used in conjunction with clinical evaluation and other diagnostic procedures. Isolation technology should make a clear diagnosis.

4, this test will not show the site of infection. It does not intend to replace isolation.

5, a significant increase in antibody levels does not rule out the possibility of infection.

6, samples collected early in the infection may not be detected IgG levels. In such cases, it is advisable to carry out IgM tests, or second serum samples, to be tested in parallel with the original samples after 14 to 21 days to confirm seroconversion.

7. Because pregnant women are passively passed from their mother to their fetus prior to delivery, they must be carefully tested. IgM testing is often a useful indicator of infection in children less than 6 months old.

8, a single sample antibody test results should not be used to diagnose the recent infection. Paired samples (acute phase and recovery phase) should be tested simultaneously to find a significant increase in seroconversion or antibody levels.

9. Samples from patients with autoimmune disease may have nonspecific responses to cells when using IFA. Those samples can not be evaluated in this way.

10. Performance test results show a comparative study of commercial forecasting devices in a defined population sample. Small differences can be found in different groups or different forecasting devices.