据央视网报道3月12日,国家药监局发布通告,批准南京诺唯赞、北京金沃夫、深圳华大因源、广州万孚生物、北京华科泰生物的新冠抗原产品自测应用申请变更。

自此五款新冠抗原自测产品正式上市。

According to CCTV.com, on March 12, the State Food and Drug Administration issued a notice to approve the self-testing application of new crown antigen products of Nanjing Novizan, Beijing Jinwofu, Shenzhen Huada Yinyuan, Guangzhou Wanfu Bio, and Beijing Huaketai Bio. Apply for a change.

Since then, five new coronavirus antigen self-test products have been officially launched.

It is reported that the new crown antigen self-test product can be very convenient for self-sampling and testing, and those over the age of 14 can perform nasal swab sampling by themselves.

The self-tester first blows his nose with toilet paper. Carefully unpack the nasal swab to avoid touching the swab tip with your hands. Then tilt the head slightly, hold the swab in one hand and stick the tail of the swab into one nostril and enter it slowly along the bottom of the lower nasal passage to go back 1-1.5 cm, then stick to the nasal cavity and rotate for at least 4 circles (the residence time is not less than 15 seconds), and then Repeat the same procedure for the other nasal cavity using the same swab.

After the sampling is completed, place the nasal swab after collecting the sample in the sampling tube immediately. The swab head should be rotated and mixed in the preservation solution for at least 30 seconds. , to ensure that the sample is sufficiently eluted in the sampling tube.

 

Only after the liquid of the swab head is squeezed dry by hand through the outer wall of the sampling tube, the swab is discarded. After capping the sampling tube, drop the liquid vertically into the sample hole of the test card.

According to the reagent instructions, the results can be interpreted after a certain period of time.

However, it should be noted that the comprehensive team of the State Council’s joint prevention and control mechanism for the new coronavirus pneumonia epidemic decided to add antigen testing as a supplement on the basis of nucleic acid testing. Nucleic acid testing is still the basis for the diagnosis of new coronavirus infection.

Antigen detection is generally used in the acute infection period, that is, the detection of samples within 7 days of the onset of symptoms in the suspected population. Both positive and negative antigen results of suspected populations should undergo further nucleic acid testing. Positive results can be used for early triage and rapid management of suspected populations, but cannot be used as the basis for the diagnosis of new coronavirus infection.

据悉,新冠抗原自测产品可以非常便捷的自行采样测试,年龄14岁以上的,可自行进行鼻腔拭子采样。

自检者先用卫生纸擤去鼻涕。小心拆开鼻拭子外包装,避免手部接触拭子头。随后头部微仰,一手执拭子尾部贴一侧鼻孔进入,沿下鼻道的底部向后缓缓深入1-1.5厘米后贴鼻腔旋转至少4圈(停留时间不少于15秒),随后使用同一拭子对另一鼻腔重复相同操作即可。

采样完成后,将采集样本后的鼻拭子立即置于采样管中,拭子头应在保存液中旋转混匀至少30秒,同时用手隔着采样管外壁挤压拭子头至少5次,确保样本充分洗脱于采样管中。

 

只有用手隔着采样管外壁将拭子头液体挤干后,将拭子弃去。采样管盖盖后,将液体垂直滴入检测卡样本孔中。

根据试剂说明书,等待一定时间后即可进行结果判读。

但需要注意的是,国务院应对新型冠状病毒肺炎疫情联防联控机制综合组决定在核酸检测基础上,增加抗原检测作为补充,核酸检测依然是新冠病毒感染的确诊依据。

抗原检测一般用于急性感染期,即疑似人群出现症状7天之内的样本检测。疑似人群抗原阳性及阴性结果均应当进行进一步的核酸检测,阳性结果可用于对疑似人群的早期分流和快速管理,但不能作为新冠病毒感染的确诊依据。

 

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