SARS-CoV-2 Antigen Test Kit (colloidal gold method)
Manufactured by BIOTEKE CORPORATION (WUXI) CO., LTD, China - https://www.bioteke.cn/
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Bioteke Rapid test device 新型冠狀病毒抗原快速檢測套裝
6月份優惠
https://www.coronavirus.gov.hk/rat/chi/kit_comparison.html
Bioteke Rapid test device 新型冠狀病毒抗原快速檢測套裝
- 香港醫管局選用
- 多間公營機構及醫院選用
- 準確度高達98.47%
- 鼻拭子測試
- 15分鐘結果快測
- 通過歐盟認證 CE
- 500套/箱
COVID-19 In Vitro Diagnostic Medical Device - detail
SARS-CoV-2 Antigen Test Kit (colloidal gold method)
Manufactured by BIOTEKE CORPORATION (WUXI) CO., LTD, China - https://www.bioteke.cn/
Device identification number2067CE Marking✓YesHSC common list (RAT)✓YesFormatNear POC / POCPhysical SupportCassetteTarget typeAntigenTargetsnucleocapsid protein,SpecimenNasopharyngeal swab, Oropharyngeal swabCross-reactivity (pathogens tested)Coronaviruses (HCoV)Lineages detectedB.1.1.7 (Alpha), B.1.351 (Beta), P.1 (Gamma),Commercial StatusCommercialisedLast Update2022-04-20 12:09:38 CETCommentshttps://www.bioteke.cn/Assay TypeImmuno-AntigenRapid DiagnosticYesReader RequiredNoSubcategoryValidity test kitMethodImmunoassayMeasurementQualitativeTime15 minutesSubclassSandwich, DoubleDetection PrincipleColloidal goldLOD175 AUCalibrationEvaluatedCrossreactivityEvaluatedFp0.72 %Fn3.51 %PrecisionEvaluatedAccuracy98.47 % ((95%CI: 96.70%~99.44%))ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity96.49 ((95%CI: 91.26%~99.04%))Clinical Specificity99.28 ((95%CI: 97.43%~99.91%))Type of antigenNucleoprotein