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PocRoc® 新冠病毒抗原快速測試劑套裝 【25套/盒】PocRoc® SARS-CoV-2 Antigen Rapid Test Kits 【25pcs/Pack】

Specification:

Sampling Rod / Antigen / Test Solution / Instruction Manual / Qualification Certificate / Tube Stand
– Detection Time: 15-20 mins
– Shelf life: 24 months
– Storage temperature: 4°C-30°C

套裝包括:
採樣棒 / 檢測結果棒 / 試管 / 說明書 / 合格證 / 管架
– 檢測時間:15-20 分鐘
– 保 質 期:24 個月
– 儲存溫度:4°C-30°C

SKU NS-013 Categories ,

$380.00

53 in stock

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Description

High quality, Registrated or approved by multinational FDA

– Effective detection of COVID-19 variants including Omicron, Delta, etc.
– Registered or certified by Registrated or approved by multinational FDA and EU.
– A rapid test kit for official use by the Singapore government.
– Approved by the German Federal Agency for Medicines and Medical Devices (BfArM) for professional use or self-testing.
– Simple and easy to use, can be operated by relatives and friends or by individual, without the need to use special professional equipment.
– Clinical study: 97% accuracy
– Qualitative results in 15-20 minutes
– Providing protection for family members/employees, effectively reducing the risk of virus transmission of invisible patients.

TEST PROCEDURE
1.Open the package and take out the test card.
2.Place the extraction tube pre-lled with test buer in the holder, then tear the sealing foil of the tube.
3. Remove the swab from its packaging and insert it through the mouth to the wall of the throat or into both nostrils. Follow the instructions for specimen
collection.
4.After collecting the specimen, put the swab into the extraction tube, rotate the swab for about 10 seconds and press the swab head against the tube wall
to release the antigen in the swab When removing the swab, squeeze the edge of the tube slightly to remove as much liquid as possible from the swab.
Dispose of swabs according to biohazard waste disposal method.
5.Install the plug on the extraction tube, put 3 drops into the sample hole of the test card and start the timer.
6.Read the result after 15 minutes. The result is considered inaccurate and invalid after 30 minutes.

WARNINGS AND PRECAUTIONS
1.For in vitro diagnostic use only.
2.Do not use the kit contents beyond the expiration date printed on the outside of the box.
3.The test kit has been authorized only for the detection of nucleocapsid proteins from SARS-CoV-2, not for any other viruses or pathogens
4.To avoid erroneous results, specimens must be processed as indicated in the assay procedure section.
5.use appropriate precautions in the collection, handling, storage and disposal of patient samples and used kit contents.
6.Package insert instructions must be carefully followed. Reliability of assay results cannot be guaranteed if operator does not carefully follow the
instructions in this package insert.
7.The best detection temperature is 20°C ~ 30°C and humidity RH is 40% ~ 60%.
8.The experiment should be carried out as soon as possible to avoid the inaccurate test result caused by extended exposure of strip in the air after the
strip is taken out from the foil pouch.
9.Dispose all specimens and materials resulted from the test as biohazardous waste.
10.Negative results do not rule out SARS-CoV-2 infection particularly in those who had been in contact with the virus. Follow-up testing with a molecular
diagnostic should be considered to rule out infection in these individuals.
11.Positive results may be due to past or present infection with non- SARS-CoV-2 coronavirus strains.

The picture is for reference only, please refer to the actual product.

高品質,獲多國衛生福利部食品藥物管理署註冊或認證
-有效檢測包括Omicron, Delta 等新冠變種病毒。
-獲多國衛生福利部食品藥物管理署及歐盟註冊或認證。
-爲新加坡政府官方使用的快速測試套裝。
-獲德國聯邦藥品和醫療器械局 (BfArM)認可,適用於專業用途或自我檢測。
-簡單易用,可由親友或自行操作,無需使用特殊專業設備和儀器。
-臨床研究︰準確率達97%
-15-20分鐘即知結果
-為家人/員工及自己增添多一層保障, 有效減少隱形患者家內外傳播病毒風險。

【檢驗步驟】
1. 打開包裝,取出檢測卡。
2. 將預封裝有裂解液的提取管放入支架中,然後撕開提取管的密封箔。
3. 從包裝中取出拭子,按照上述採樣方法進行採樣。
4. 採集樣本後,將拭子放入提取管中,旋轉拭子10 秒左右,將拭子頭壓在管壁上,釋放拭子中的待測物。取出拭子時,輕
擠試管邊緣,盡可能多地從拭子中擠出液體。按照生物危害廢物處理方法處理拭子。
5. 將塞子安裝在提取管上,向樣品孔中滴入3 滴樣品,啟動計時器。
6. 15 分鐘後讀取結果。 30 分鐘後的結果被認為是不准確和無效的。

【注意事項】
1. 僅供體外診斷使用。
2. 請勿使用過期試劑盒做檢測。
3. 該試劑盒僅被授權用於SARS-CoV-2 中核衣殼蛋白的檢測,而不能用於其他任何病毒或病原體的檢測。
4. 為避免產生錯誤結果,必須按照測試步驟中所述對樣品進行處理。
5. 在收集、處理、儲存和處置患者樣品和用過的試劑盒內容物時,請採取適當的預防措施。
6. 必須認真遵守使用說明書,如果操作員未嚴格按照本說明書進行操作,則無法保證檢測結果的可靠性。
7. 最佳檢測溫度為20℃~ 30℃,濕度RH 為40% ~ 60%。
8. 檢測應盡快進行,避免檢測卡從箔袋中取出後,由於長時間暴露在空氣中而導致檢測結果不准確。
9. 將檢測產生的所有標本和材料作為生物危害性廢物處理。
10.陰性結果不能排除SARS-CoV-2 感染,特別是在那些已經接觸該病毒的人群中,應該考慮通過分子診斷的後續檢測來排
除這些個體的感染。

圖片僅供參考,請以實物為準。

 

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