Virus sampling kit

一次性使用病毒采样管

【产品名称】一次性使用病毒采样管 【Product Name】Disposable Virus Sampling kit

【包装规格】培养液2mL/管、采样拭子【Packing Details】Solution 2mL/Tube、Sampling Swab.

【预期用途】【Intended use 】

本产品用于采集咽喉或鼻腔分泌物的病毒检测样本，经拭子采取的样本保存于培养液中，可用于病毒检测、培养与分离等。

This product is to collect virus detection samples from throat or nasal secretions, and the swab samples will be kept in culture medium, which can be used for virus detection, culture and isolation.

【主要结构】【Main composition】
本产品主要有采样管、管帽、培养液及配套用拭子组成。The product mainly consists of sample tube, cap, solution and swab

【储存条件及有效期】【Storage Conditions and validity】

2-25℃贮存，可使用至标签载明期限。病毒培养液也可单独存放于-20℃，如存放于-20℃环境，请在使用前放置在2-8℃解冻后再使用。采样后常温运输不超过96小时。

Store at 2-25 °C, and it can be used until the expiry date on the label. The culture solution can also be stored separately at -20℃. If stored at -20℃, please unfreeze it at 2-8℃ before use. Transportation under room temperature no more than 96 hours of after sampling

【样本要求】【Sample Requirements】

1、    采样拭子可采取口咽部位及鼻咽部位样本。 Sample can be taken from throat and nose with the swab

2、    样本采集后若不立即进行核酸提取纯化，室温可保存7天。Samples can be stored at room temperature for 7 days if not arrange nucleic acid extraction and purification immediately after collection

3、    采取后的样本应存放于样本培养液中，若不立即检测可冷藏或冷冻保存，但应避免反复冻融。 The collected samples should be stored in the sample preservation solution. If not tested immediately, they can be stored at room temperature or refrigerated or frozen, but repeated freeze-thaw should be avoided

4、    采样拭子在使用前严禁放入培养液中；采样后应立即放入装有培养液的采样管中，在靠近顶端处折断拭子，然后旋紧管帽，密封于塑料袋或其它包装容器中，按规定温度保存、送检。 Sampling swabs must not be placed in the sample preservation solution before use; they should immediately be placed in the preservation tube containing the sample preservation solution after sampling. Break the swab near the top, and then tighten the tube cover. It should be sealed in a plastic bag or other packaging container, stored at a specified temperature and submitted for inspection.

【使用方法】【Instructions】

1. 取出采样管及采样拭子，采样前，在采样管的标签上标注相关样品信息或者贴条形码标签。
   
2. 1. Take out the sampling tube and swab. Before sampling, mark the relevant sample information on the label of the preservation tube or attach the bar code label.
   
3. 取出采样拭子（若采样拭子为独立包装，请从包装袋尾部易撕口处撕开即可），根据不同的采样要求，用采样拭子在相应的部位采样。

3. 采样后迅速将采样拭子放入采样管中，在靠近顶端处将采样拭子折断，使采样拭子头部浸在培养液中，弃去采样柄，然后旋紧管帽。
4. 新鲜采集的样本应在48小时内运送至实验室，若用于病毒核酸检测，应尽快提取纯化核酸；未能48小时内送至实验室的，室温可保存7天，若需长期贮存应置于-40~-70℃保存（稳定贮存的时间与条件请各实验室根据最终实验目的进行验证）。
5. 为提高检出率，增加采集样本的病毒载量，可同时采集口咽及鼻咽的拭子样本，同时放入一支采样管中送检。
   
6. 2.Take out the sample swab (if the sample swab is packaged independently, please tear it off from the easily torn mouth at the end of the packaging bag) and sample with the sample swab at the corresponding part according to different sampling requirements. A) throat sampling: first press the tongue with a tongue spatula, then extend the head of the sampling swab into the throat and wipe the bilateral pharyngeal tonsils and the posterior pharyngeal wall, and gently rotate to fully sample. B) nasal cavity sampling: Measure the distance from the tip of the nose to the earlobe with a swab and mark it with your finger. Insert the swab into the nasal cavity in the direction of the nose (face), The swab should be extended at least half the length from the earlobe to the tip of the nose. put the swab in the nose for 15-30 seconds. Gently rotate the swab 3-5 times to take out the swab.
   
7. 3.    Place the swab into the storage tube immediately after sampling, break off the sample swab, dip the head of the swab in the preservation solution, discard the sampling handle and tighten the cap.
   
8. 4.    Freshly collected samples should be transported to the laboratory within 48 hours. If used for viral nucleic acid detection, nucleic acid should be extracted and purified as soon as possible. If it cannot be sent to the laboratory within 48 hours, it can be stored at room temperature for 7 days. If long-term storage is needed, it should be stored at -40~-70℃ (the stable storage time and conditions should be verified by each laboratory according to the final experimental purpose).
   5.    In order to improve the detection rate and increase the viral load of the collected samples, samples from throat and nose with swab can be collected simultaneously and put into a sampling tube for examination.
   

【产品性能指标】【Product Performance Index】

1. 外观：包装完整、液体无渗漏，标签应清晰、准确、牢固；培养液澄清透亮无杂质。若病毒保存管破损或管帽漏液禁止使用。
2. 采样拭子应整洁、无毛刺。
3. 培养液容量：培养液容量为2mL±10%。
4. 培养液酸碱度：
   
5. 1. Appearance: complete packaging, no liquid leakage, the label should be clear, accurate and firm; the solution should be clear and pure. Do not use if the virus preservation liquid tube is damaged or the tube cap leaks.
   
6. 2. The swab should be clean and free of burrs.
   
7. 3. Virus preservation fluid capacity: the fluid capacity in the preservation tube is 2ml±10%.
   
8. 4. Ph of culture medium: