One assay. All known ebolaviruses.
Overview
Get in touch: ebola@aldatubio.com
| 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. |
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 |
| 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 |
Email ebola@aldatubio.com
Get in touch
Documentation
Instructions for Use
Other Documentation
Real-Time PCR 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
Real-Time PCR Templates
Kit Contents
| 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 |