Andover Bio
A Rapidly Emerging Biotech, Providing Your Source for COVID-19 Test Kits and Other Products
617-804-5155
Test Composition
40 cassette tests / Kit
Sealed foil pouch with cassette device and desiccant
Specimen diluent
Instructions for use
List Price
$1400.00 USD per test kit*
$35.00 USD per test
Contact us for volume discount pricing
*Plus S&H and applicable tax
Applications
Auxiliary diagnosis
Detection of recent or previous infection
Specimens
Serum/plasma/venous whole blood specimens
Detection
Immunocapture of SARS-CoV-2 IgM and IgG antibodies
Colloidal gold-coated SARS-CoV-2 antigens bind to antibodies, if present
Compounds bind to pre-coated antibodies generate purple lines in the cassette device
Test Solution
IgM Positive
The presence of two purple bands (T and C) within the IgM result window
IgG Positive
The presence of two purple bands (T and C) within the IgG result window
Negative
Only one purple band appearing at the control line (C)
Invalid
If the control line (C) fails to appear (regardless of the T line), the test is invalid
Results
Result within 15 minutes
Regulatory
NMPA certified
RUO in the United States
FDA EUA application is registered and in process
Kit Solution
50 tests / Kit
QC standards
Positive control
No-template control (NTC)
Internal control
List Price
$1750.00 USD per test kit*
$35.00 per test
Contact us for volume discount pricing
*Plus S&H and applicable tax
Shelf Life
5 days at 2-8°C
6 months at -18°C
Applications
Confirmed case diagnosis
Identification of patient under investigation (PUI) cases
Release of recovered patients
Screening of close contacts and high-risk groups
Specimens
Sputum
Nasopharyngeal Swabs
Bronchoalveolar lavage fluid (BALF)
Throat swabs
Amplification and Detection
TaqMan Reverse Transcription PCR
FAM: SARS-CoV-2 detection
HEX/VIC: Internal control
Regulatory
CE-IVD
NMPA certified
FDA EUA Granted in the United States
Compatible with commonly used Real-Time PCR Systems
*EUA intended for use with ABI 7500 Fast Dx
Please contact us for detailed technical specifications on any of our products at info@AndoverBio.com or call us at 617-804-5155
A. Yes, all of our COVID-19 test kits are in the EUA process, or have received EUA from the FDA.
BGI received EUA for their COVID-19 RT-PCR test on March 27, 2020.
A. These tests have received China’s NMPA issued medical device registration certificate for clinical use, as well as being part of the FDA issued Emergency Use Authorization (EUA) process. The BGI COVID-19 RT-PCR test also has EU CE-mark. These tests are being used world-wide and receiving positive feedback.
A. Yes. On March 16, 2020, the FDA updated its Policy for Diagnostic Tests for Coronavirus Disease-2019 because of the ongoing Public Health Emergency. This policy allows for testing in laboratories or by healthcare workers at the point-of-care, including serology testing for SARS-CoV-2 from clinical samples. The policy does not apply to at-home testing.
A. In response to the COVID-19 pandemic, we are offering test kit options to physicians, hospitals, laboratories, and other professionals only. These test kits are not intended for at-home use. If you feel that you need to be tested, please reach out to your local healthcare provider and ask them about ordering these tests.
A. Pricing is found with the product descriptions, and on the ordering page. Pricing is per kit with 40 cassette tests per kit for the Innovita COVID-19 Antibody Test Kit and 50 tests/samples per kit for the BGI COVID-19 RT-PCR Test Kit. Individual tests are not available. We also offer volume discounts, provided with a discount code used at checkout. Contact us to get a volume discount quote on your product(s) of interest.
A. Click on the order button for the product(s) of interest. You will be directed to an ordering form that you must fill out completely and include the volume discount code for preferred pricing. Each type of product has its own ordering form and must be filled out separately. Credit card ordering is not currently available for the BGI COVID-19 RT-PCR ordering form.
Andover Bio
1 617 804 5155
AMDL
Michael Wah
Unit 1618, Vanta Industrial Centre
21-33 Tai Lin Pai Road
Kwai Chung, Hong Kong
011 852 9352 0282
011 852 3103 3477
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