O-Mec INTERNAL USE ONLY
Who is Atila and what do they do?
Started in 2009, they are a group of PhDs who have focused on innovative nucleic acid amplification and detection technologies including both isothermal amplification and PCR. Dr. Wang is globally recognized as an authority and innovator in infectious disease testing. He has traveled all over the world with WHO personnel and infectious disease specialists for HPV testing in Indonesia and many African countries.
What is the iAMP COVID-19 Detection Kit and what are its benefits?
isothermal AMPlification (iAMP), is a real-time fluorescent isothermal assay on raw samples. The 2 major innovations are that no RNA extraction is needed and dry (vs liquid) swab tubes are used to make transport to labs simpler. Atila’s unique detection reagents eliminate the RNA extraction process which involves significant time and money associated with additional instrumentation and personnel. It is a huge bottleneck in testing throughput as RNA Extraction takes greater than 3 times the PCR instrumentation procedure time.
How costly is the RNA Extraction step that iAMP COVID-19 eliminates?
The RNA extraction required with other detection kits is about 3X more time consuming than the PCR procedure by itself. iAMP eliminates the extra time and cost associated with additional personnel, instrumentation, and automated pipetting instrumentation down time. There is anecdotal evidence that automated pipetting instruments are not operational almost half the time.
RNA Extraction procedures create hazardous waste. Does iAMP eliminate this?
No hazardous waste is created using iAMP because it does not require the normal RNA Extraction steps.
Where is the iAMP COVID-19 Detection Kit made?
All kits are made in the USA in California.
What other Detection Kits do you offer besides COVID-19?
https://atilabiosystems.com/our-products/An extensive list includes these categories: 4 Prenatal Kits, 17 Cancer Kits, & 16 Infectious Disease Kits
What is included in the iAMP COVID-19 Detection Kit?
The kit includes the company’s primer mix, buffer mix, positive and negative control templates, and the sample collection device, which has fiber swabs, collection tubes, and buffer mix. The kits can be purchased with or without swabs, please specify.
What is your recommendation for swabs?
Our swabs have a “break” point designed to snap off at the right distance to properly fit in the UTMs (Universal Transport Media) tubes we provide. We have also found that getting the kits and swabs together is beneficial from an operational perspective. Lab personnel don’t need to find or inventory them separately and the quantities are matched together.
How do physicians and patients use the iAMP COVID-19 Detection Kit?
The iAMP COVID-19 Detection Kit, a qualitative real-time RT-PCR test, detects SARS-CoV-2 in nasal, nasopharyngeal, and oropharyngeal swabs. Typically, a long nasopharyngeal swab is inserted into the patient’s nose or throat. The swab’s tip is broken off into a dry tube and sent to a lab.
Is the iAMP COVID-19 Detection Kit approved by the FDA?
Yes, on April 10, 2020, the FDA gave EUA approval.https://www.fda.gov/media/136872/download
Who can use this iAMP COVID-19 test?
According to the FDA, the use of the test is limited to high-complexity CLIA-certified labs.
How many iAMP COVID-19 Detection Kits have been sold and are currently in the field?
>2 million assays/tests as of August. This is 20K kits of 100 each.
In which countries and continents have iAMP COVID-19 Detection Kits been sold?
US, South America, and Europe.
What published reports on COVID-19 molecular assay evaluations showing sensitivity and specificity are there?
Use the WHO World Health Organization’s Diagnostic Finder to navigate to:FINDDx – SARS-COV-2 Molecular Assay Evaluation: Results were updated as of July 3, 2020Atila’s data is copied below.https://www.finddx.org/covid-19/sarscov2-eval-molecular/molecular-eval-results/
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Company
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Product name
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Product number
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Gene target
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Verified LOD (copies / reaction)
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Avg Ct (lowest dilution 10/10)
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Clinical sensitivity (50 positives)
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Clinical specificity*
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Lot No.
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PCR platform**
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Supplier recommend-ed Ct cut-off
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(100 negatives)
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Atila BioSystems Inc.
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Atila iAMP
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iAMP-COVID-100-RUO
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ORF1ab
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50–100
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N/A
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100%
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99%*
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COVID 20200320
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Bio-Rad CFX96 deep well
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Any signal is considered positive (isothermal)
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COVID-19 Detection (isothermal detection)
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(95%CI:
93, 100)
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(95%CI:
95, 100)
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|
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N
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1–10
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N/A
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100%
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100%
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|
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(95%CI:
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(95%CI:
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|
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93, 100)
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96, 100)
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What Real-Time PCR Instruments do your iAMP COVID-19 kits work with?
iAMP COVID-19 detection kits should be used with one of the following validated, and commonly used, Real-Time PCR system with FAM/HEX fluorescence channels:
- Atila PowerGene 9600 Plus Real-Time PCR System
- Applied Biosystems 7500 Real-Time PCR Systems
- Bio-Rad CFX96 Real-Time System
- Roche LightCycler® 480 Instrument II
What is the PowerGene 9600 series for Real-Time PCR and how does it work?
https://atilabiosystems.com/our-products/linegene-9600-plus-real-time-pcr-system/
The 96 well Power-Gene 9600 Plus uses a specially-made Peltier (thermo-electric cooler) and advanced fiber optic technology. The unique patented block dissipation technology and bottom detection mode provides better heating/cooling rate, temperature accuracy, uniformity and stability. Excitation wavelengths are 300-800nm and emission wavelengths cover 500-800nm.
These standard dyes are approved:
F1: FAM, SYBR Green I; F2: VIC, HEX, TET, JOE, CY3, TAMRA
F3: ROX, TEXAS-RAD; F4: CY5, Quasar-670; F5: CY5.5, Quasar-705
Fast speed of dual-color scanning and the design of 5 channel detection cover the whole fluorescence detection wavelength.
What throughput is possible using the PowerGene?
The cycle lasts about 1 hour. The 96 wells include 2 references wells. One technician can run about 700 samples per 8 hour shift.
Note: There is No RNA Extraction prep step required and that eliminates the workflow bottleneck using existing instrumentation. As an example, RNA extraction may take 24 samples per 45 minutes which is about 200/shift. The RNA Extraction time is >3X longer than the PowerGene PCR procedure and therefore using iAMP COVID-19 detection kit saves significant time and money.
What data results come from the PowerGene instrument and how is it used?
The PowerGene is similar to other PCR equipment that is computer controlled. The data is exported in an Excel format that EHR depts. compatible with their existing systems.
For Patients, what iAMP COVID-19 Detection Kit information do you provide?
The 2 page Patient Fact Sheet for COVID-19 testing is available at:https://www.fda.gov/media/136871/download
For Health Care Providers (HCP), what iAMP COVID-19 Detection Kit information do you provide?
The 3 page Patient Fact Sheet for COVID-19 testing is available at:https://www.fda.gov/media/136869/download
Where are the iAMP COVID-19 Instructions for Use (IFU)
The EUA IFU is available at:
https://www.fda.gov/media/136870/download
What Patents are issued or pending from Dr. Wang?
>20 patents issued or pending.https://patents.justia.com/inventor/youxiang-wang
Do your PowerGene instruments need FDA approval to use?
No. Generally speaking, CMOs (Chief Medical Officers) will do their own in-house validation of the instrument together with test kits just as they would for other new tests. This typically takes them 1 or 2 days.
What is the lead time for iAMP COVID-19 Detection Kits?
1-2 week depending on volume.
What is the capacity for making for iAMP COVID-19 Detection Kits?
200,000/week as of August.
What are the shipping requirements for the iAMP COVID-19 Detection Kits?
Atila ships kits by FedEx overnight, delivery by 3pm. The kits must be kept cold and therefore packed inside a styrofoam/insulated box with dry ice and ice packs for transport.
What is the shelf life and storage temp for for iAMP COVID-19 Kits?
How are the iAMP COVID-19 Detection Kits packaged?
Each kit consists of enough supplies for 100 assays
Specimen Handling and Storage
• Use freshly collected specimens for optimal test performance.
• Specimens can be stored at room temperature for up to 12 hours, or -20°C for up to 2 days after collection and before sample processing.
• If a delay in sample processing is expected, store dry swab specimens at -70°C or lower. Avoid free-thaw cycles of the specimens.
• As soon as specimens are added to the 1x iAMP COVID-19 Sample Buffer Mix (i.e., called “processed specimens”) they need to be tested within 2 hours and may not be stored.
What training for iAMP COVID-19 do you provide?
Live video conference training, e.g. Zoom may be arranged. A training video is also in the works.
What training for Atila’s PowerGene PCR instrument do you provide?
This is mostly Plug N’ Play. A setup and training video is in the works.
Does Atila have a Customer Service Hotline?
Contact 650-968-8848 during work hours.
Pricing for iAMP COVID-19 Detection Kit
$2500/kit MSRP (with 100 assays). Does not include swabs.
Swabs for Kits: $225/100 MSRP
Quantity pricing for kits is available.
Contact Dan at OmecMEDICAL at 888-777-6121 ext. 101
Pricing for PowerGene RT-PCR Equpment
PowerGene: $35,000 MSRP for 1-10 machines.
Contact Dan at OmecMEDICAL at 888-777-6121 ext. 101
Payment Terms
100% Prepaid unless other arrangements have been made.
Banking info for wire transfers to Bank Of America are on the invoice.
Contact Dan at OmecMEDICAL at 888-777-6121 ext. 101
