QUICKVUE ANTIGEN TEST 

                                          FDA  Authorization

안녕하세요. 의류협회 사무국입니다. 

이제 집에서도 따로 처방전없이 자가 진단할 수 있는 The QuickVue SARS Antigen Test 키트를 아래와 같은 도매가격으로 구입이 가능합니다. 본 제품은 FDA Authorization으로 승인받은 OTC ANTIGEN TEST제품으로 검사방법은 아래 사이트에서 자세히 확인하실 수 있습니다. 구입을 원하시는 분은 아래 Order information이나 협회로 연락주십시오. AntigenTest와 제품에 대한 자세한 사항은 아래 사이트의 내용을 참고하세요.
(Ref: https://www.quidel.com/immunoassays/quickvue-sars-antigen-test) 

1 box 25 tests/ $ 300 (Members price $275)

The QuickVue SARS Antigen Test* is a lateral flow immunoassay that allows for the rapid, qualitative detection of the nucleocapsid protein antigen from SARS-CoV-2 in anterior nares (NS) swab specimens directly from individuals who are suspected of COVID-19 by their healthcare provider within the first five days of the onset of symptoms or, from individuals without symptoms or other epidemiological reasons to suspect COVID-19 when tested twice over two or three days with at least 24 hours and no more than 36 hours between tests.. Testing is limited to laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, that meet the requirements to perform moderate, high or waived complexity tests. This test is authorized for use at the Point of Care (POC), i.e., in patient care settings operating under a CLIA Certificate of Waiver, Certificate of Compliance, or Certificate of Accreditation.

Test type: Lateral flow immunoassay
Specimen type: Nasal (NS) swab specimen
Turnaround time: 10-15 minutes
FDA status:  Emergency Use Authorization (EUA) Granted
CLIA complexity: Waived, Moderate, or High
 
 

• *This product has not been FDA cleared or approved; but has been authorized by FDA under an EUA for use by authorized laboratories;
• This product has been authorized only for the detection of proteins from SARS- CoV-2, not for any other viruses or pathogens; and,
• The emergency use of this product is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Federal Food, Drug and Cosmetic Act, 21 U.S.C. §360bbb-3(b)(1), unless the declaration is terminated or authorization is revoked sooner.

Ordering information:

Contact KAMA to order or complete the form below.
info@kamainfo.org  213-5362/5262
KAMA
1458S.San Pedro St. L60