COVID-19 RAPID TESTS

Spera™ Rapid Antigen Test

(Box of 10)

Fast

Results in 10-15 minutes so your patients don’t have to wait.

Accurate

Developed in partnership with the NIH and manufactured in Japan, Spera™ is the most sensitive and highest quality rapid test on the market. Give your patients what they paid for.

 

Comfortable

Lower nasal sample collection with state-of-the-art Copan flocked swabs for terrific patient comfort.

Convenient

Packaged in boxes of 10 so you can easily inventory, store, and apportion tests within your organization.

COVID-19 Rapid Test

Spera™ Rapid Antigen Test

The most sensitive rapid antigen test for detecting the 25+ strains of the new Omicron variant.

General Details

      • Sensitivity: 92% for all variants. But ask us for the new Omicron data, even better.
      • Specificity: 97% for all strains.
      • Test Type: Rapid Antigen. Lateral flow immunoassay intended for the qualitative detection of SARS-CoV-2 nucleocapsid protein.
      • Sample Type: Lower nasal swab
      • Interfering Substances: No cross-reaction with species tested.
      • Authorization: FDA EUA. CLIA certification required.
      • Manufacturer: Xtrava Health (USA). Place of Manufacture: Japan
      • Controls: Positive and negative controls available
      • Shelf-life: 12 months
      • Storage: 3–30°C

Box components

      • 10 COVID-19 Test Cartridges

      • 10 Sterile Shallow Nasal Swabs

      • 10 Sample Collection Tubes with buffer

      • 10 Sample Collection Caps

      • Convenient Sample Collection Tube Stand

      • Instructions for Use (IFU)

      • Quick Reference Guide

Intended Use

Qualitative detection of nucleocapsid protein antigen from SARS-CoV-2 in direct anterior nasal swabs from individuals suspected of COVID-19 by their healthcare provider within the first five (5) days of symptom onset. Emergency use of this test is limited to authorized laboratories.

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.

CONTACT

Direct Connect

6 + 7 =

Phone

(310) 957-9891