image-wave-pattern-light@2x.png

SPERA™ Product Documentation

SPERA™ COVID-19 Ag Test

In the USA, the SPERA™ COVID-19 Ag Test has not been FDA cleared or approved; but has been authorized by FDA under an EUA for use by authorized laboratories; use by 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. The SPERA™ COVID-19 Ag 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.

PDF Downloads

Instructions of Use 
 

FDA EUA letter
 

Fact Sheets for
Health Care Providers

Quick
Reference Guide

Safety Data Sheet
 

External Quality Control IFU

Fact Sheet for Individuals