Q : How do I purchase Cellex tests within the USA?Please feel free to place an order via our e-commerce platform. For prospective clients who want to become a distributor or partner, please email us at email@example.com or firstname.lastname@example.org.
Q : How do I purchase Cellex tests outside the USA?For international customers, please email us email@example.com. We will assign a Sales Representative to coordinate with you.
Q : What do you have in the test kit/box?
The kit component configuration for the Cellex antigen test kit is below:
Cellex qSARS-CoV-2 Antigen Rapid Test Kit Size 25 tests Test Cassette (#) 25 Sample Buffer (# of bottles) 1 Sample Swab (#) 25 Sample Extraction Tube (#) 25 Tube Holder (#) 1 Quick Reference Guide 1 IFU Leaflet 1
The kit component configuration for the Cellex antibody test kit is below:
Cellex qSARS-CoV-2 IgG/IgM Rapid Test Kit Size 25 tests Test Cassette (#) 25 Sample Diluent (# of bottles) 1 Quick Reference Guide 1 IFU Leaflet 1
Q : What is the clinical performance of the Cellex antigen and antibody tests?Here is the clinical data for the Cellex antigen test (compared to a FDA Emergency Use Authorized RT-PCR test):
Positive Percent Agreement: 35/37 = 94.6% (81.81-99.24%)
Negative Percent Agreement: 181/182 = 99.5% (96.98-99.99%)
Here is the clinical data for the Cellex antibody test (compared to a FDA Emergency Use Authorized RT-PCR test):
Positive Percent Agreement: 120/128 = 93.8% (95%CI: 88.2-96.8%)
Negative Percent Agreement: 240/250 = 96.0% (95% CI: 92.8-97.8%).
Q : What are the storage conditions for the Cellex antigen and antibody test kits?Please store the detector buffer and test kits at 2-30 ℃.
Q : Who can purchase Cellex’s antibody and antigen tests?The Cellex antibody tests have both FDA EUA and CE mark. Testing is limited to laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. 263a, to perform moderate and high complexity tests.
The Cellex antigen tests has CE mark and can be ordered by people who want to use them for surveillance, screening, research, and validation purposes (non-diagnostic).
Q : Are there guidelines for applying antigen tests to asymptomatic clients?Yes, please visit the link: https://www.cdc.gov/coronavirus/2019-ncov/lab/resources/antigen-tests-guidelines.html
Q : What can cause an "invalid" result?An invalid result is usually due to operation errors during sample collection or reagent use. For an invalid result, please repeat testing with a new sample and new test. If this happens again, please contact your Sales Representative.
Q : What is the lead time for receiving Cellex test kits?For orders fewer than 400 kits via the Cellex ecommerce platform, the shipment will be scheduled within 1-2 days. For orders over 400 kits, please send an email to firstname.lastname@example.org email@example.com for a lead time estimate.
Q : What payment methods are available?For US domestic orders, we accept checks, bank wire transfer and card (VISA, Master Card, Discovery, Amex, Apple Pay). For international orders, we accept wire transfer only.