瘧原蟲(chóng)抗原檢測(cè)試劑盒說(shuō)明書(shū)（美國(guó)Cortez）
瘧疾快速診斷試劑卡
用于人血液中Pf和Pv抗原的定性檢測(cè)
一、應(yīng)用
Cortez瘧原蟲(chóng)抗原免疫層析快速檢測(cè)卡是一種檢測(cè)瘧原蟲(chóng)抗原快速膜篩查試劑。本試驗(yàn)是一種新一代的側(cè)向免疫層析實(shí)驗(yàn)。用于人體全血中特異性抗原PF、 PV的定性檢測(cè)。
二、儲(chǔ)存
試劑盒可在4-30℃儲(chǔ)存，測(cè)試卡必須密封，在效期之前使用。禁止凍存，勿使用過(guò)期試劑。
三、材料
試劑盒成分
? 測(cè)試卡
? 緩沖液
? 使用說(shuō)明書(shū)
未提供的物品
? 加樣槍
? 小刀
? 計(jì)時(shí)器
四、樣品收集和準(zhǔn)備
靜脈采血
1. 靜脈穿刺收集全血，放入含有EDTA的抗凝管中。
2. 樣品收集后要儲(chǔ)存于2-8℃的環(huán)境下，可保存三天；如需保存更長(zhǎng)時(shí)間則應(yīng)凍存。
3. 如果儲(chǔ)存于2-8℃，全血樣品必須三天內(nèi)使用。
使用柳葉刀收集
1. 用酒精對(duì)取血部位進(jìn)行消毒
2. 用手指擠壓采血部位，消過(guò)毒的柳葉刀刺破皮膚，進(jìn)行采血。
3. 用消毒紗布或者消毒棉拭去第一滴血。
4. 毛細(xì)管接觸采血。
五、實(shí)驗(yàn)步驟
測(cè)試卡，緩沖液，樣品，還有質(zhì)控等使用之前必須達(dá)到室溫。（15-30℃）
1. 加入5ul全血于樣品孔“s”處。
2. 加入兩滴（約80ul）緩沖液于箭頭所指處。
3. 20分鐘內(nèi)讀取實(shí)驗(yàn)結(jié)果。
六、結(jié)果說(shuō)明（請(qǐng)參考圖示）
1. 惡性瘧原蟲(chóng)陽(yáng)性
在“C”和“1”處同時(shí)顯色，則表明惡性瘧原蟲(chóng)陽(yáng)性。
2. 間日瘧原蟲(chóng)陽(yáng)性
在“C”和“2”處同時(shí)顯色，則表明間日瘧原蟲(chóng)陽(yáng)性。
3. 惡性瘧原蟲(chóng)和間日瘧原蟲(chóng)都為陽(yáng)性
三條測(cè)試線(xiàn)都出現(xiàn)，表明惡性瘧原蟲(chóng)和間日瘧原蟲(chóng)都為陽(yáng)性。
4.陰性反應(yīng)
只有質(zhì)控線(xiàn)出現(xiàn)，表明惡性瘧原蟲(chóng)和間日瘧原蟲(chóng)都為陰性。
5.實(shí)驗(yàn)失敗
質(zhì)控線(xiàn)沒(méi)有出現(xiàn)，表明實(shí)驗(yàn)失敗需重新檢測(cè)。
七、局限性
1. 必須嚴(yán)格按照使用說(shuō)明進(jìn)行實(shí)驗(yàn)。
2. 抗凝血物質(zhì)如EDTA等不影響實(shí)驗(yàn)結(jié)果。
3. 此試劑盒主要檢測(cè)人全血中瘧原蟲(chóng)HRP-2和乳酸脫氫酶，對(duì)于瘧原蟲(chóng)的診斷篩查具有很高的實(shí)用價(jià)值。
4. 不同批號(hào)間的試劑不能混合。
5. 此試劑盒不能用于檢測(cè)PM,,盡管它對(duì)HRP-2和pyLDH有很高的精確性。也不能作為疾病診斷的唯一依據(jù)。
我司為美國(guó)CorteZ公司在中國(guó)地區(qū)戰(zhàn)略合作伙伴，負(fù)責(zé)該公司產(chǎn)品的總經(jīng)銷(xiāo)及售后服務(wù)工作。
此說(shuō)明書(shū)由廣州健侖生物科技有限公司技術(shù)人員翻譯，如有錯(cuò)漏之處請(qǐng)以英文原版為準(zhǔn).
【中國(guó)總代】 廣州健侖生物科技有限公司
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Los Angeles based Diagnostic Automation/Cortez Diagnostics, Inc. offers a Malaria Rapid diagnostic Test for Pan-LDH antigens. This Malaria Rapid Test can detect all four species of malaria Plasmodium falciparum, Plasmodium vivax, Plasmodium oval, and Plasmodium malaria. The Malaria Rapid Test is for the qualitative detection of one or more of the known Malaria species: P. falciparum, p. vivax, P. oval, and/or P. malaria by detecting lactate dehydrogenase (LDH) in human blood. This Malaria Rapid Testis for in vitro diagnostic use only.
Users of this Malaria Rapid Test know that Malaria is a serious parasitic disease characterized by fever, chills, and anemia and is caused by a parasite that is transmitted from one human to another by the bite of infected Anopheles mosquitoes. When administering this Malaria Rapid Test, it is important to know that there are four kinds of malaria that can infect humans: Plasmodium falciparum, Plasmodium vivax, Plasmodium ovale, and Plasmodium malariae. In humans, the parasites (called sporozoites) migrate to the liver where they mature and release another form, the merozoites. The disease now occurs in more than 90 countries worldwide, and it is estimated that there are over 500 million clinical cases and 2.7 million malaria-caused deaths per year. At the present, malaria is diagnosed by looking for the parasites in a drop of blood, as done in this Malaria Rapid Test. Blood will be put onto a microscope slide and stained so that the parasites will be visible under a microscope.
Diagnostics Automation/Cortez Diagnostics, Inc.'s Malaria Rapid Test for pan-LDH antigens contains a membrane strip, which is pre-coated with anti- pan LDH monoclonal antibodies on the test line region of the strip. When a Whole Blood specimen from this Malaria Rapid Test is applied at one end of the membrane and following the application of the assay buffer, it reacts with the colloidal gold-anti-pan LDH antibodies that have already been applied to the specimen pad on the Malaria Rapid Test. The mixture then migrates chromate-graphically towards the other end of the membrane and reacts with the monoclonal antibodies previously placed on the Malaria rapid test line region. If the blood contains one or more of the four Malaria species, a colored line will appear in the Malaria rapid test line region, showing a positive result. The absence of the colored line in the test region indicates a negative result therefore the whole blood does not contain detectable levels of any of the Malaria species. To serve as a procedural control on this Malaria rapid test, a colored line will always appear at the control line region if the Malaria rapid test has been performed properly. This control line serves to validate the performance of the Malaria rapid test.
Diagnostic Automation/Cortez Diagnostics offers two formats of the Malaria Rapid Test. This Malaria Rapid Test for Pan-LDH antigens and a Malaria Rapid Test for pf and pv antigens. For more information regarding these Malaria Rapid Tests, please contact Customer Service. This Malaria Rapid Test for pan-LDH antigens is available in cassette format only.
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