PANDAA qDx SARS-CoV-2

The only assay using adaptive PCR to to ensure performance is never affected by variants.

PANDAA qDx SARS-CoV-2
The only real-time PCR-based COVID-19 test that is designed to ensure that diagnostic performance isn’t affected by COVID-19 variants now or in the future.

 

Questions? email us: COVID19@aldatubio.com
PANDAA qDx™ SARS-CoV-2 is uniquely designed to provide accurate quantitative detection of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) specific RNA, the causative agent of the coronavirus disease 2019 (COVID-19).
  • Fast – delivers accurate results from RNA in 1 hour
  • One of the most sensitive SARS-CoV-2 molecular diagnostics available, with a limit of detection 0.075-0.1 copies / μL (75-100 copies / mL) across various extraction and detection platforms.
  • With clinical samples, 100% positive percent agreement and 98% negative percent agreement with the Abbott RealTime SARS-CoV-2 assay.
  • Platform-agnostic – compatible with sample prep and qPCR platforms in most clinical labs

For research use only (RUO). Not for use in diagnostic procedures.

Additional information

Kit Controls

Synthetic RNA, Extraction Controls
SKU

PQ.0012.Kit.96.RUO

Overview

PANDAA qDx™ SARS-CoV-2 is comprised of a single reaction mix containing reagents to amplify, detect and quantify targets within the SARS-CoV-2 genome. Two SARS-CoV-2 targets, located in the N gene and RdRp gene, respectively, are amplified by distinct PANDAA primer sets and detected by FAM™-labelled hydrolysis probes. An Internal Control (IC) target is amplified by PANDAA primers and reported using a VIC®-labelled hydrolysis probe.

 

PANDAA sensitivity is not compromised by mutations found in patient samples and has no loss in performance with the B.1.1.7 (UK), B1.351 (South Africa) or P.1 (Brazil) variants. We continue to actively monitor for the emergence mutations in our assay targets and proactively evaluate changes in performance.

 

For Research Use Only. This test has not been cleared or approved by the U.S. Food and Drug Administration (FDA). This product is covered by one or more patents, trademarks and / or copyrights owned or controlled by Aldatu Biosciences, Inc.

Kit Contents

Contents Volume (µL)
PRxB Buffer 2,100 µL
SARS-CoV-2 PANDAA 65 µL
RT Enzyme 5 µL
Internal Control RNA 120 µL
Positive Control 50 µL
Negative Control 50 µL

Overview

PANDAA qDx™ SARS-CoV-2 is comprised of a single reaction mix containing reagents to amplify, detect and quantify targets within the SARS-CoV-2 genome. Two SARS-CoV-2 targets, located in the N gene and RdRp gene, respectively, are amplified by distinct PANDAA primer sets and detected by FAM™-labelled hydrolysis probes. An Internal Control (IC) target is amplified by PANDAA primers and reported using a VIC®-labelled hydrolysis probe.

 

PANDAA sensitivity is not compromised by mutations found in patient samples and has no loss in performance with the B.1.1.7 (UK), B1.351 (South Africa) or P.1 (Brazil) variants. We continue to actively monitor for the emergence mutations in our assay targets and proactively evaluate changes in performance.

 

Kit Contents

Contents Volume (µL)
PRxB Buffer 2,100 µL
SARS-CoV-2 PANDAA 65 µL
RT Enzyme 5 µL
Internal Control RNA 120 µL
Positive Control 50 µL
Negative Control 50 µL

For Research Use Only. This test has not been cleared or approved by the U.S. Food and Drug Administration (FDA). This product is covered by one or more patents, trademarks and / or copyrights owned or controlled by Aldatu Biosciences, Inc.

Performance Summary

PANDAA qDx Clinical Concordance with Abbott RealTime SARS-CoV-2
Samples used in the retrospective study were initially tested for SARS-CoV-2 with the Abbott RealTime SARS-CoV-2 assay and designated positive or negative based on the manufacturer’s instructions then stored at 4°C. Clinical lab staff selected blinded negative samples and positive samples across a range of Ct values, as determined by the Abbott RealTime SARS-CoV-2 assay, for analysis by PANDAA qDx SARS-CoV-2. The positive percent agreement (PPA) for the retrospective samples (n=88) was 100% [95% CI: 83.9% – 100.0%] and negative percent agreement (NPA) was 100% [95% CI: 94.6% – 100.0%].

 

Prospective samples were run side-by-side on two Abbott m2000sp extraction platforms and then tested with the Abbott RealTime SARS-CoV-2 or PANDAA qDx SARS-CoV-2 assays. The positive percent agreement (PPA) for the prospective samples (n=90) was 100% [95% CI: 93.9% – 100.0%] and negative percent agreement (NPA) was 93.5% [95% CI: 78.6% – 99.2%]. PANDAA detected two positive samples that were negative by the Abbott m2000 assay.

 

The positive percent agreement for combined prospective and retrospective samples (n=178) was 100% [95% CI: 95.5% – 100.0%] and negative percent agreement was 98.0% [95% CI: 92.8% – 99.8%].
Abbott RealTime SARS-CoV-2
PositiveNegative
PANDAA SARS-CoV-2Positive802
Negative096
Analytical Sensitivity
Limit of Detection (LoD) studies were performed to determine the lowest detectable concentration of SARS-CoV-2 at which ≥95% of were positive by spiking a simulated nasal matrix with inactivated SARS-CoV-2 (Isolate USA-WA1/2020, BEI Resources) prior to extraction.

 

The LoD was determined to be the lowest concentration of SARS-CoV-2 at which ≥95% of replicates were positive. The LoD is 0.075 copies / µL (75 copies / mL) for the KingFisher Flex / Apex extraction platform and the QuantStudio 3 / 5 for detection, and 0.1 copies / µL (100 copies / mL) for the Abbott m2000 extraction and detection platform.

 

Concentration
[Viral Copies / µL]		n%
0.5 cp / µL5/5100%
0.4 cp / µL5/5100%
0.3 cp / µL5/5100%
0.2 cp / µL5/5100%
0.1 cp / µL5/5100%
0.075 cp / µL20/20100%
0.050 cp / µL12/2060%
Negative0/200%
PANDAA qDx Clinical Concordance with Abbott RealTime SARS-CoV-2

 

Samples used in the retrospective study were initially tested for SARS-CoV-2 with the Abbott RealTime SARS-CoV-2 assay and designated positive or negative based on the manufacturer’s instructions then stored at 4°C. Clinical lab staff selected blinded negative samples and positive samples across a range of Ct values, as determined by the Abbott RealTime SARS-CoV-2 assay, for analysis by PANDAA qDx SARS-CoV-2. The positive percent agreement (PPA) for the retrospective samples (n=88) was 100% [95% CI: 83.9% – 100.0%] and negative percent agreement (NPA) was 100% [95% CI: 94.6% – 100.0%].

 

Prospective samples were run side-by-side on two Abbott m2000sp extraction platforms and then tested with the Abbott RealTime SARS-CoV-2 or PANDAA qDx SARS-CoV-2 assays. The positive percent agreement (PPA) for the prospective samples (n=90) was 100% [95% CI: 93.9% – 100.0%] and negative percent agreement (NPA) was 93.5% [95% CI: 78.6% – 99.2%]. PANDAA detected two positive samples that were negative by the Abbott m2000 assay.

 

The positive percent agreement for combined prospective and retrospective samples (n=178) was 100% [95% CI: 95.5% – 100.0%] and negative percent agreement was 98.0% [95% CI: 92.8% – 99.8%].

 

Abbott RealTime SARS-CoV-2
PositiveNegative
PANDAA SARS-CoV-2Positive802
Negative096

 

Analytical Sensitivity

 

Limit of Detection (LoD) studies were performed to determine the lowest detectable concentration of SARS-CoV-2 at which ≥95% of were positive by spiking a simulated nasal matrix with inactivated SARS-CoV-2 (Isolate USA-WA1/2020, BEI Resources) prior to extraction.

 

The LoD was determined to be the lowest concentration of SARS-CoV-2 at which ≥95% of replicates were positive. The LoD is 0.075 copies / µL (75 copies / mL) for the KingFisher Flex / Apex extraction platform and the QuantStudio 3 / 5 for detection, and 0.1 copies / µL (100 copies / mL) for the Abbott m2000 extraction and detection platform.

 

Concentration
[Viral Copies / µL]		n%
0.5 cp / µL5/5100%
0.4 cp / µL5/5100%
0.3 cp / µL5/5100%
0.2 cp / µL5/5100%
0.1 cp / µL5/5100%
0.075 cp / µL20/20100%
0.050 cp / µL12/2060%
Negative0/200%

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