九安为什么要在九月底前，工厂要投入使用？要履行订单BID要求。
Produce 250,000 OTC antigen tests per day (assuming five (5) operational days per week with the ability to scale to seven (7) days per week as needed) after 90 days of operation (October 1, 2022).
十月一日前，产能达到标准。
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九安为什么要在九月底前，工厂要投入使用？要履行订单BID要求。
Produce 250,000 OTC antigen tests per day (assuming five (5) operational days per week with the ability to scale to seven (7) days per week as needed) after 90 days of operation (October 1, 2022).
十月一日前，产能达到标准。
At the state’s discretion, leverage state offered space in Valencia, California, which includes roughly 100,000 sq. ft. for the production and storage of rapid OTC antigen tests.
The state offered warehouse space includes roughly 100,000 sq. ft. (including temperature controlled, power generated office space, production space, and 45,000 sq. ft. for storage of assembled and packaged test kits). The State has not determined additional provisions at this time.
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加州提供的生产车间和储藏空间。
Ideal test would be a multiplex test able to identify COVID-19, influenza, RSV and other respiratory infectious diseases.
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已经发展成为多功能检测盒，将来成为家庭必备的医疗检测产品。
新冠、流感、呼吸道合胞病毒和其它呼吸道传染的多重测试盒。
很好奇，如果ihealth这家在加州的工厂竣工并正式生产会不会邀请加州州长 加文·纽森去参加生产线产品正式下线的仪式？代表美国新冠试剂盒本土生产能力极大提升！当年，马里兰州州长拉里·霍根 (Larry Hogan) 参加关于位于弗雷德里克的 Ellume 制造厂的 COVID-19竣工仪式。狂吹：每月进行令人难以置信的 1500 万次 COVID-19 家庭测试。$九安医疗(SZ002432)$
发一下原文链接，谢谢😊
九安在美国政府有人的
就是之前加州的rfi2项目，九安中了吗
Requirements
– Test Type 11 • Provide verification of FDA authorization for the elected OTC antigen tests.
• Secure a reliable supply chain to produce OTC antigen tests at a significant scale including all components necessary to construct test kits (including pediatric).
• Develop a test that generates results quickly (~15 minutes or less) and meets market standards related to reliability, with standard lab-based COVID-19 (positive predictive agreement at least 80% and negative predictive agreement at least 98% within seven (7) days of symptom onset) tests.
• Ideal test would be a multiplex test able to identify COVID-19, influenza, RSV and other respiratory infectious diseases.
• Ideal test would include a Clinical Laboratory Improvement Amendments (CLIA) waiver for clinical use (i.e., OTC may be used for Point of Care (POC) testing).
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Provide verification of FDA authorization for the elected OTC antigen tests
这个将国内许多生产厂商排除在外了。
目前只有九安拥有FDA授权，或者有些正在申请中。
可以外包。
如果每天250000剂这个量太小了，怎么吃得下大单？单位是盒？一盒8剂？
Solution or Service
• The solution already has FDA EUA.
• The solution or service demonstrates innovation in the field to further disrupt the COVID-19 antigen tests market to increase availability and accessibility.
• The solution or service includes a commitment to the State of California for the production capacity required.
• The solution or service may include innovations beyond COVID-19 such as flu, RSV, etc.
• The solution or service demonstrates ability to provide tests that can meet a variety of needs across use cases including CLIA waiver for clinical use or OTC for at home use.
• A solution that simplifies the test experience for priority populations and those who are either disproportionally impacted by the virus or at greater risk of contracting the virus.
Approach
• The approach is implementable July 1, 2022.
• The approach is scalable by October 1, 2022.
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要求。