SAMPINUTE™

FAST AND PRECISE RESULT WITHIN 10 MINS

HIGH SENSITIVITY WITH MES IMMUNOASSAY

nasopharyngeal swab sample(NPS)

Sampinute™ Analyzer (Immunoassay analyzer)
Sampinute™ Analyzer detects specific biomarkers via immunoassay (MESIA; Magnetic Electrochemical Sandwich lmmunoassay) from a small amount of test sample. Sampinute™ Analyzer is intended to be used as an in vitro diagnostic medical device. Please read the user manual thoroughly for correct use and keep it for future reference. For use under an Emergency Use Authorization (EUA) only.

Sampinute™ COVID-19 Antigen MIA (Test cartridge)
The Sampinute™ COVID-19 Antigen MIA is intended for the qualitative detection of spike proteins of SARS-CoV-2 in nasopharyngeal swab (NPS) specimens in conjunction with the Sampinute™ Analyzer. The test cartridge, with the analyzer, incorporates a technique called magnetic force-assisted electrochemical sandwich immunoassay. The technique entails the use of magnetic nanoparticles (MNPs) and electrochemical sensors conjugated with monoclonal antibodies specific for the receptor binding domains (RBD) of SARS-CoV-2 spike proteins to facilitate the electrochemical sandwich immunoassay. 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 high complexity tests.

Sampinute™ COVID-19 Antigen MIA Test Cartridge Product Component

The Sampinute™ COVID-19 Antigen MIA test cartridge can test 25 specimens or quality control samples. The test cartridge box contains the following:
Sampinute™ COVID-19 Antigen MIA (25)
Reagent solution (25)
Sterile nasal swabs (25)
Negative control solution (1)
Positive control solution (1)
Package Insert (1)

MATERIALS NOT SUPPLIED IN KIT
Sampinute™ Analyzer
Adapter, A power cord
Barcode scanner
Printer
Pipette and disposable tips to transfer the specimen (or a glass capillary)
Vortex shaker (or a mixer)
Sterile nylon flocked swab
BD UVT, Copan UTM, or VTM, the preparations in accordance with CDC protocols

Sampinute™ COVID-19 Antigen MIA Warnings and Precaution

Only use Sampinute™ COVID-19 Antigen MIA test cartridges with the Sampinute™ Analyzer.
Do not use expired Sampinute™ COVID-19 Antigen MIA test cartridges.
Do not use Sampinute™ COVID-19 Antigen MIA test cartridges that are damaged or broken.
The recommended measurement temperature range is 15-30°C (59-86°F).
Only use the Sampinute™ COVID-19 Antigen MIA test cartridges after a full system check according to the Sampinute™ Analyzer user manual.
Wear disposable protective gloves when handling the Sampinute™ COVID-19 Antigen MIA test cartridges and human specimens.
If transport of the samples is required, the following transport media have been tested and shown not to interfere with the performance of the test.
■ BD™ Universal Viral Transport System
■ Copan® UTM-RT® System
■ CDC VTM according to SOP#: DSR-052-04
Gently press the Sampinute™ COVID-19 Antigen MIA test cartridge down onto the tray of the Sampinute™ Analyzer gently until it will go no further.
The product is for single use only. Do not re-use.
Place the test cartridge on the tray with the labelled side facing up.
Take a precise amount of sample for each test and insert it into the sample inlet at once.
Discard the Sampinute™ COVID-19 Antigen MIA test cartridge after use as required by internal quality control procedures and in accordance with local, state and federal regulations or accreditation requirements.
Do not swallow or damage the Sampinute™ COVID-19 Antigen MIA test cartridge.
The product is for in vitro diagnostics.
The product is indicated for use in clinical laboratories.
Follow safety procedures set by your institution for working with chemicals and handling biological specimens.
This test has not been FDA-cleared or -approved. The test has been validated, but FDA’s independent review of this validation is pending.
This test has been validated only for the detection of proteins from SARS-CoV-2, not for any other viruses or pathogens.

※
This test has not been FDA cleared or approved; the test has been authorized by FDA under an Emergency Use Authorization (EUA) for use by laboratories certified under the CLIA that meet the requirements to perform moderate or high complexity tests. This test is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostic tests 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 authorization is terminated or revoked sooner. This test has been authorized only for the detection of proteins from SARSCoV-2, not for any other viruses or pathogens. This webpage is intended for U.S. audiences only. This webpage may contain information on products that are targeted to U.S. audiences and could contain product details or information not approved in countries or regions outside U.S.