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PANDAA® Ebola

One assay. All known ebolaviruses.

For Research Use Only. This test has not been cleared or approved by the U.S. Food and Drug Administration (FDA). PANDAA® is a registered trademark of Aldatu Biosciences. 

Overview

Shipping in early June.

Get in touch: ebola@aldatubio.com

Key Features

  • One assay. Broad ebolavirus coverage.
    PANDAA® Ebola delivers pan-species real-time RT-PCR detection of all known ebolavirus species — Bundibugyo, Reston, Sudan, Taï Forest, and Zaire — in a single reaction.
  • Designed for genetic drift.
    PANDAA adaptive PCR technology helps maintain detection across genetically diverse ebolaviruses by accounting for sequence variation in primer and probe binding regions.
  • Sensitive across ebolavirus diversity.
    Analytical sensitivity demonstrated down to 5.7 PFU/mL for Bundibugyo ebolavirus, with ≥95% detection at 10 copies/reaction across 16 tested ebolavirus isolates.
  • An additional layer of specimen confidence
    PANDAA® Ebola surpasses other lab-based real-time PCR assays by including an additional Sample Adequacy Control to help verify specimen quality and sample addition, supporting greater confidence in ebolavirus-negative results.
  • Platform-agnostic speed.
    Compatible with most sample prep and real-time PCR platforms, delivering accurate results from RNA in < 90 minutes.

Technical Specifications

Product name PANDAA® Ebola
Regulatory status Research Use Only (RUO). Not intended for use in diagnostic procedures.
Intended use Real-time RT-PCR assay for qualitative pan-species detection of orthoebolavirus RNA.
Assay method One-step real-time RT-PCR using PANDAA adaptive PCR technology and hydrolysis probe detection.
Assay type Qualitative detection. Ct values are generated for detected samples.
Detection target Pan-ebolavirus target detected in the FAM channel.
Specimen type evaluated EDTA plasma.
Sample input for extraction 140 µL EDTA plasma.
Recommended extraction method QIAamp Viral RNA Mini Kit or compatible viral RNA extraction workflow.
Workflow time Approximately 2 hours total workflow time: ~30 minutes assay setup plus ~60–80 minutes PCR run time, depending on instrument.
Controls Exogenous, non-competitive Internal Control RNA monitors extraction and amplification; Sample Adequacy Control detects human RNase P in human biological specimens.
Validated instruments ABI 7500 / 7500 Fast, QuantStudio 5, Mic Real-Time PCR Cycler, and Rotor-Gene Q 5/6 Plex.
Additional compatible instruments Other real-time PCR instruments capable of detecting green, yellow, and red channels may be compatible, including CFX96, LightCycler 96, and LightCycler 480 II.
Analytical sensitivity summary LoD with inactivated virus: 5.7 PFU/mL for Bundibugyo ebolavirus, 50 PFU/mL for Zaire ebolavirus, and 200 PFU/mL for Sudan ebolavirus.
Analytical specificity 99.3% among 900 negative control replicates using synthetic RNA inclusivity testing; all 29 tested cross-reactivity organisms were non-reactive.

Analytical Sensitivity

Inactivated virus, PFU/mL

Limit of detection was evaluated using gamma-irradiated infected cell lysate and supernatant spiked into EDTA plasma, followed by extraction from 140 µL sample using the QIAamp Viral RNA Mini Kit. LoD was defined as the concentration detected with ≥95% positivity for Sudan ebolavirus and Zaire ebolavirus; the Bundibugyo ebolavirus LoD was determined by probit.

Virus isolate tested Common name Limit of detection
Bundibugyo virus, Butalya-811250 Bundibugyo ebolavirus (BDBV) 5.7 PFU/mL
Ebola virus, Makona Zaire ebolavirus (EBOV/ZEBOV) 50 PFU/mL
Sudan virus, Boniface Sudan ebolavirus (SUDV) 200 PFU/mL

Synthetic RNA sensitivity and inclusivity, copies/reaction

Inclusivity was evaluated using dPCR-traceable in vitro transcribed RNA representing 16 isolates across five ebolavirus species. All tested isolates were detected at 20 copies/reaction, and all tested isolates showed ≥ 95% detection at 10 copies/reaction.

Species Isolates 20 copies/rxn 10 copies/rxn 5 copies/rxn
Bundibugyo ebolavirus 1 100% 97.2% 75.0%
Reston ebolavirus 2 100% 100% 77.8%–97.2%
Sudan ebolavirus 6 100% 95.7%–100% 69.4%–97.2%
Taï Forest ebolavirus 1 100% 95.8% 45.8%
Zaire ebolavirus 6 100% 100% 91.7%–100%
Overall 16 100% across all tested isolates ≥ 95% across all tested isolates 45.8%–100%, isolate-dependent

Kit Contents

The kit includes all amplification reagents for up to 96 reactions and includes one (1) each of the positive control, negative control, and internal control RNA.
Contents Volume (µL)
PRxB Buffer [x2] 500 µL
Ebolavirus PANDAA [x2] 35 µL
Stop-Start RT Enzyme 8 µL
Internal Control RNA 120 µL
EBOV Positive Control 100 µL
Negative Control 100 µL
Weight 45 g
Dimensions 3.2 × 5.7 × 8.3 cm
Weight 45 g
Dimensions 3.2 x 5.7 x 8.3 cm
Kit Size 96 reactions (20 µL)
SKU 4011096

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Get in touch

Documentation

Instructions for Use


Other Documentation

  • Safety data sheets (link)
  • Certificate of analysis (link)

Real-Time PCR Templates

Download real-time PCR template files from aldatu.bio/qpcr-templates

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. PANDAA® is a registered trademark of Aldatu Biosciences, Inc. PANDAA primer and probe designs are proprietary to Aldatu Biosciences.

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Documentation

Instructions for Use


Other Documentation

  • Safety data sheets (link)
  • Certificate of analysis (link)

Real-Time PCR Templates

Download real-time PCR template files from aldatu.bio/qpcr-templates

Kit Contents

The kit includes all amplification reagents for up to 96 reactions and includes one (1) each of the positive control, negative control, and internal control RNA.
Contents Volume (µL)
PRxB Buffer [x2] 500 µL
Ebolavirus PANDAA [x2] 35 µL
Stop-Start RT Enzyme 8 µL
Internal Control RNA 120 µL
EBOV Positive Control 100 µL
Negative Control 100 µL
Weight 45 g
Dimensions 3.2 × 5.7 × 8.3 cm
Weight 45 g
Dimensions 3.2 x 5.7 x 8.3 cm
Kit Size 96 reactions (20 µL)
SKU 4011096