pandaa qdx - aldatubio.com · for ordering inquiries, please...

1
al•da•tu [ɒl-də-tu]: to become something different For ordering inquiries, please email: [email protected] +1.978.705.1036 www.aldatubio.com COVID-19 test kits for Emergency Use Authorization in CLIA labs: Fast: Accurate, reliable results from RNA in 1 hour Scalable: Efficient workflow; test 94 samples per run (plus controls) Plugs in: Compatible with sample prep and qPCR equipment in most CLIA labs Supported: Templates, reagents, and support for on-site implementation Available Now: PANDAA qDx Fast, Simple, Scalable Diagnostics PANDAA qDx SARS-CoV-2 Qualitative Nucleic Acid Test PANDAA qDx products are diagnostic testing kits based on gold standard real-time PCR technology. The SARS-CoV-2 test kit delivers reliable results from RNA in one hour. Sensitive and durable SARS - CoV - 2 detection Demonstrated clinical concordance with other EUA test kits (CDC COVID-19 Test, Abbott SARS-CoV-2 EUA) Validated for EUA clinical use* on: - m2000 RealTime System [Abbott] - KingFisher Flex/QuantStudio real-time PCR instruments [Thermo Fisher] Compatible with many nucleic acid extraction and real-time PCR instruments PANDAA technology is uniquely durable to mutations that may arise in the target site; low risk of false negatives Test cost is fully reimbursable under billing codes U0003/U0004 Allows for efficient allocation of scarce hospital isolation resources, and for critical healthcare workers to be screened quickly and regularly Two SARS-CoV-2 targets: N and RdRp genes LoD: 100 copies/mL sample; 10 copies/reaction Specificity: 100% (no false positives) *For Research Use Only. Not for use in diagnostic procedures, except by CLIA labs working within COVID-19 Emergency Use Authorization guidance from the U.S. Food and Drug Administration.

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Page 1: PANDAA qDx - aldatubio.com · For ordering inquiries, please email:sales@aldatubio.com•+1.978.705.1036 • COVID-19 test kits for Emergency Use Authorization in CLIA labs: Fast:

al•da•tu [ɒl-də-tu]: to become something different

For ordering inquiries, please email: [email protected] • +1.978.705.1036 • www.aldatubio.com

COVID-19 test kits for Emergency Use Authorization in CLIA labs:

Fast: Accurate, reliable results from RNA in 1 hour

Scalable: Efficient workflow; test 94 samples per run (plus controls)

Plugs in: Compatible with sample prep and qPCR equipment in most CLIA labs

Supported: Templates, reagents, and support for on-site implementation

Available Now:

P A N D A A q D xFast, Simple, Scalable Diagnostics

PANDAA qDx SARS-CoV-2Qualitative Nucleic Acid Test

PANDAA qDx products are diagnostic testing kits based on

gold standard real-time PCR technology.

The SARS-CoV-2 test kitdelivers reliable results from RNA

in one hour.

Sensitive and durable SARS-CoV-2 detection

• Demonstrated clinical concordance with other EUA test kits (CDC COVID-19 Test, Abbott SARS-CoV-2 EUA)

• Validated for EUA clinical use* on:

- m2000 RealTime System [Abbott]

- KingFisher Flex/QuantStudio real-time

PCR instruments [Thermo Fisher]

• Compatible with many nucleic acid extraction and real-time PCR instruments

• PANDAA technology is uniquely durable to mutations that may arise in the target site; low risk of false negatives

• Test cost is fully reimbursable under billing codes U0003/U0004

• Allows for efficient allocation of scarce hospital isolation resources, and for critical healthcare workers to be screened quickly and regularly

Two SARS-CoV-2 targets: N and RdRp genesLoD: 100 copies/mL sample; 10 copies/reaction

Specificity: 100% (no false positives)

*For Research Use Only. Not for use in diagnostic procedures, except by CLIA labs working within COVID-19 Emergency Use Authorization guidance from the U.S. Food and Drug Administration.