猴痘临床试验样品采集注意事项

猴痘临床试验联系IVDEAR王小姐！

(三）标本采集方法

1.皮肤病变标本:视病变情况进行相应病变标本采集，需后期进行病毒分离的样本，收集管不含样本保存液。

(1)病变皮疹、痘疱表面和/或渗出物的拭子:使用无菌聚酯或涤纶拭子用力涂抹病变部位，以确保收集足够的病毒DNA，将拭子放置无菌收集管中。

(2）痘疱液:用酒精棉球对皮损处进行消毒，并自然干燥。用无菌针头和注射器吸取液体,放置于1.5至2毫升的无菌带0型橡胶圈的螺旋盖塑料管。

(3）皮疹或痘疱表皮、皮疹内液体拭子采集:用酒精棉球对皮损处进行消毒，并自然干燥。用一次性手术刀（或无菌26号针头）打开并移除小泡或脓疱的顶部皮肤，将小泡顶部皮肤放置于1.5至2毫升的无菌带О型橡胶圈的螺旋盖塑料管中。用无菌聚酯或涤纶拭子擦拭皮损底部，将拭子放置于无菌收集管中。

(4）痘痂或硬皮:用酒精棉球对皮损处进行消毒，并自然干燥。用无菌26号针头或剪刀取至少4块痂皮，每块痂皮要来自不同的身体部位。将痂皮放置于1.5至2毫升的无菌带О型橡胶圈的螺旋盖塑料管中。

注意:可以将两个相同类型的病变标本收集在一个管中，zui好是从身体的不同部位收集的，且外观不同。不同类型病变（如痘疱液和痘痂)不能放在同一-管中。尽量每种类型标本收集两份，检测时先对其中一份进行检测，仅在第 一份结果不确定时再对第二份进行检测。

2.咽拭子:用2根聚丙烯纤维头的塑料杆拭子同时擦拭双侧咽扁桃体及咽后壁，将拭子放入无菌采样液管中，尾部弃去，旋紧管盖。

3.血液标本:尽量采集急性期、恢复期双份血清。第 一份血清应尽早(zui好在发病后7天内)采集，第二份血清应在发病后第3～4周采集。采集量5ml,以空腹血为佳，建议使用含有EDTA抗凝剂的真空采血管采集血液标本5ml后，室温静置30分钟，1500～2000rpm离心10分钟,分别收集血浆和血液中细胞于无菌螺口塑料管中。

4.血清标本:用真空负压采血管采集血液标本5ml，室温静置30分钟，1500～2000rpm离心10分钟，收集血清于无菌螺口塑料管中。

5.其他材料:依据设计需求规范采集。

（3） Sample collection method

1. Skin lesion sample: collect the corresponding lesion sample according to the condition of the lesion. For the sample that needs to be separated from the virus later, the collection tube does not contain sample preservation solution.

(1) Swab of lesion rash, pimple surface and/or exudate: use sterile polyester or polyester swab to smear the lesion site forcefully to ensure that sufficient viral DNA is collected, and place the swab in a sterile collection tube.

(2) Blister liquid: sterilize the skin lesions with alcohol cotton balls and dry them naturally. Suck the liquid with sterile needle and syringe, and place it in 1.5 to 2ml sterile plastic tube with screw cap with 0-shaped rubber ring.

(3) Collection of skin rash or blister epidermis and liquid swab in skin rash: sterilize the skin lesions with alcohol cotton balls and dry them naturally. Open and remove the top skin of the vesicle or pustule with a disposable scalpel (or sterile No. 26 needle), and place the top skin of the vesicle in a 1.5 to 2ml sterile band О A type rubber ring in the plastic pipe with screw cover. Wipe the bottom of the lesion with sterile polyester or polyester swab, and place the swab in the sterile collection tube.

(4) Scab or hard skin: sterilize the skin lesions with alcohol cotton balls and dry them naturally. Use sterile No. 26 needle or scissors to take at least 4 scabs, each from a different part of the body. Place eschar on 1.5 to 2ml sterile band О A type rubber ring in the plastic pipe with screw cover.

Note: Two specimens of the same type of lesions can be collected in one tube, preferably from different parts of the body, with different appearances. Different types of lesions (e.g

Blister fluid and scab) cannot be put in the same tube. Try to collect two samples of each type. When testing, first test one of them, and then test the second only when the first result is uncertain.

2. Pharyngeal swab: use two plastic rod swabs with polypropylene fiber head to wipe both sides of the pharyngeal tonsils and posterior pharyngeal wall at the same time, put the swab into the sterile sampling solution tube, discard the tail, and tighten the tube cover.

3. Blood sample: try to collect double serum in acute stage and recovery stage. The first serum should be collected as soon as possible (preferably within 7 days after the onset), and the second serum should be collected within 3 to 4 weeks after the onset. Collect 5ml of blood, preferably fasting blood. It is recommended that 5ml of blood sample be collected with a vacuum blood collection tube containing EDTA anticoagulant, then stand at room temperature for 30 minutes, centrifugate at 1500~2000 rpm for 10 minutes, and collect cells in plasma and blood respectively in a sterile screw shaped plastic tube.

4. Serum sample: Collect 5ml of blood sample with vacuum negative pressure collecting vessel, leave it at room temperature for 30 minutes, centrifugate at 1500~2000 rpm for 10 minutes, and collect the serum in sterile screw mouth plastic tube.

5. Other materials: collected according to the design re