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COVID-19 Diagnostics – Advanta™ Dx SARS-CoV-2 RT-PCR Assay

A High-Throughput, Extraction-Free Diagnostic SARS-CoV-2 Detection Test

For Use Under Emergency Use Authorization Only

COVID-19 Diagnostics – Advanta™ Dx SARS-CoV-2 RT-PCR Assay

Highlights [FDA EUA 획득] Fluidigm은 침(타액)에서 SARS-CoV-2를 검출하는 High-Throughput, Extraction-Free의 진단법을 개발

Fluidigm 은 FDA 긴급 사용 허가(EUA)를 받은 진단법을 개발했으며, 이 검사 방법을 이용하여 침(타액)에서 SARS-CoV-2를 검출할 수 있습니다.

Advanta™ Dx SARS-CoV-2 RT-PCR Assay 는 qPCR 기반 검사법으로, Fluidigm의 독자적인 microfluidic 기술과 Juno™ 및 Biomark™ HD system을 활용하여 COVID-19(코로나바이러스) 감염이 의심되는 환자의 침(타액) 샘플로부터 높은 처리량과 확장 가능한 검사를 할 수 있습니다. extraction-free 한 샘플 처리, 모듈식 워크플로우 및 large batch-sample size가 특징인 하는 Advanta Dx SARS-CoV-2 RT-PCR Assay 는 신뢰할 수 있는 결과를 제공하는 동시에 검사량 또한 향상시킬 수 있습니다.

Test Platform Highlights

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Intended Use:
The Advanta Dx SARS-CoV-2 RT-PCR Assay is a real-time reverse transcription (RT)PCR test intended for the qualitative detection of nucleic acid from the SARS-CoV-2 in saliva specimens collected without preservatives in a sterile container from individuals suspected of COVID-19 by their health care provider. Testing is limited to laboratories which are certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, and meet requirements to perform high complexity tests.

Results are for the identification of SARS-CoV-2 RNA. The SARS-CoV-2 RNA is generally detectable in saliva specimens during the acute phase of infection. Positive results are indicative of the presence of SARS-CoV-2 RNA; clinical correlation with patient history and other diagnostic information is necessary to determine patient infection status. Positive results do not rule out bacterial infection or co-infection with other viruses. The agent detected may not be the definite cause of disease. Laboratories within the United States and its territories are required to report all positive results to the appropriate public health authorities.

Negative results do not preclude SARS-CoV-2 infection and should not be used as the sole basis for patient management decisions. Negative results must be combined with clinical observations, patient history, and epidemiological information. Negative results for SARSCoV-2 RNA from saliva should be confirmed by testing of an alternative specimen type if clinically indicated.

The Advanta Dx SARS-CoV-2 RT-PCR Assay is intended for use by qualified and trained clinical laboratory personnel specifically instructed and trained in the techniques of real-time PCR and in vitro diagnostic procedures. The Advanta Dx SARS-CoV-2 RT-PCR Assay is only for use under the Food and Drug Administration’s Emergency Use Authorization.

Advanta™ Dx SARS-CoV-2 RT-PCR Assay Flyer Instructions for Use Learn More

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