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Home / News / Company News / Goldsite COVID-19 SARS-CoV-2 Antigen Test Kit(ATK) on process in Thailand FDA

Goldsite COVID-19 SARS-CoV-2 Antigen Test Kit(ATK) on process in Thailand FDA

Author:Scarlett     Publish Time: 2021-09-16      Origin:Site

Goldsite COVID-19 SARS-Cov-2 Nasal Antigen Test Kit (ATK) for self-test (ชุดตรวจสำหรับ Covid-19 ประเภทตรวจหาแอนติเจนด้วยตนเอง) is being processd by FDA in thailand. Good news comes in that after the evaluation Thailand health authority lab reach an expert consensus that the sensitivity and specificity of the kit are 100% and 96.67% respectively, matching with Goldsite' internal and other third-party conducted clinical report data of 100%, 97.17% respectively. Prof. Dr. Teerawat Hemajuta (Doctor Theerawat), Director of the Center for Emerging Health Sciences Faculty of Medicine Chulalongkorn University stated that a good Rapid ATK test must have 100% sensitivity. This is a substantial proof that Goldsite's Self test Rapid Antigen Test Kit (ATK) keeps showing its excellent and stable performance.

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Main Features of Goldsite SARS-CoV-2 ATK for self-test

  • EASY. No special equipment and expertise needed.

  • Accurate. Clinical performance of sensitivity and specificity: 100%, 97.17%

  • RAPID. Only 12 mins waiting time.

  • Nasal, nasopharyngeal and oropharyngeal swabs acceptable

  • Good correlation with RT-PCR detection.

  • Room temperature storage

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Goldsite Diagnostics Inc., founded in 1999, is a leading Chinese diagnostics manufacturer specializing in in-vitro diagnostics devices and reagents.

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