Biosensors Hardware Test Report

Page 130

RAPTOR Criteria Table Grading Scale

Attribute Weight (1 to 10)

Description

Singleplex Sensitivity Gram+

10

Limit of detection (Gram + bacteria), B. anthracis

Singleplex Sensitivity Gram-

10

Limit of detection (Gram - bacteria), Y. pestis

Singleplex Sensitivity DNA Virus

10

Singleplex Sensitivity RNA Virus

Attribute

Unit of Measure

Ideal Instrument

Vendor Supplied Information

Hardware Testing Overall Score %

Low (1-3)

Medium (4-7)

High (8-10)

Grade

cfu/ml

Bacteria: 10e7-10e9

Bacteria: 1000-10e6

Bacteria: 1-100

10

cfu/ml

Bacteria: 10e7-10e9

Bacteria: 1000-10e6

Bacteria: 1-100

10

Limit of detection (DNA Virus), Vaccinia

pfu/ml

Virus: 10e7-10e9

Virus: 1000-10e6

Virus: 1-100/mL

10

Limit of detection (RNA Virsu), VEE

pfu/ml

Virus: 10e7-10e9

Virus: 1000-10e6

Singleplex Sensitivity Toxin

10

Limit of detection (Toxin), Botulinum Type A Toxin

mass/mL

Toxins: ug/mL

Multiplex Sensitivity Gram+

5

Limit of detection (Gram + bacteria), B. anthracis

cfu/ml

Bacteria: 10e7-10e9

Multiplex Sensitivity Gram-

5

Limit of detection (Gram - bacteria), Y. pestis

cfu/ml

Bacteria: 10e7-10e9

Multiplex Sensitivity - DNA Virus

5

Limit of detection (DNA Virus), Vaccinia

pfu/ml

Multiplex Sensitivity - RNA Virus

5

Limit of detection (RNA Virsu), VEE

pfu/ml

Multiplex Sensitivity Toxin

5

Limit of detection (Toxin), Botulinum Type A Toxin

Multiplex

9

Number of reportable agents per run

# individual Score = 1 for Score = 5 for Score =8+ for targets per test 1 target 2 targets 3+ targets

Score

Claim

Grade

100

5.00E+04

6

100

No Claim

0

10

100

1.00E+05

Virus: 1-100/mL

10

100

Toxins: ng/mL

Toxins: pg/mL

10

Bacteria: 1000-10e6

Bacteria: 1-100

10

Bacteria: 1000-10e6

Bacteria: 1-100

Virus: 10e7-10e9

Virus: 1000-10e6

Virus: 10e7-10e9

mass/mL # of agents per run

Score

(Wt x Grade)

Grade

60

>5,000,000

1

10

0

50,000,000

3

30

6

60

>100000000

1

10

N/a

0

0

N/a

0

0

100

10ng/mL

7

70

> 10,000 ng/mL

2

20

50

1.00E+06

#VALUE!

0

0

10

50

2.50E+05

#VALUE!

0

0

Virus: 1-100/mL

10

50

1.00E+06

#VALUE!

0

0

Virus: 1000-10e6

Virus: 1-100/mL

10

50

1.00E+08

#VALUE!

0

0

Toxins: ug/mL

Toxins: ng/mL

Toxins: pg/mL

10

50

50 ng/mL

0

0

1 = 0 score; 2-7

8-19

20-34+

10

90

4

2

18

4

2

18

(Wt x Grade)

#VALUE!

(Wt x Grade)

Multiplex

9

Number of individual targets per test

Batch Processing

9

If looking for a single agent, the number of samples that can be processed at the same time by one analyzer.

# of samples

1 = 0 score; 2-9

Boot Up

2

Time required for warm-up and calibration prior to sample analysis

minutes

14+

Sample Preparation Time

8

Time required from receipt of sample until it is ready to be analyzed.

minutes

35+

Analysis Time

9

Time required to provide a test answer after the analysis has been initiated.

minutes

35+

15<35

Sample Preparation

Info Only

Sample preparation required?

Yes/No

Total Analysis Time

Info Only

The duration of time to provide final identification of target from raw data.

minutes

Weight

10

Approximate weight of instrument with power source

lbs

24-36

8<24

2<8

10

100

12.3

5

50

12.3

10

100

Instrument Size

9

square feet

3.5+ sqft

1.5<3.5 sqft

0 <1.5 sq ft

10

90

1

8

72

1

8

72

Logistical Footprint

Info Only

Approximate footprint of instrument only in operational mode Approximate footprint of instrument with ancillary equipment Approximate weight of ancillary equipment (microcentrifuge, plate shaker, plate washer, laptop)

10

90

4

4

36

4

4

36

50+

10

90

1

0

0

1

0

0

6<14

0<6

10

20

0

10

20

0

10

20

15<35

0<15

10

80

0

10

80

0

10

80

0<15

10

90

15

7

63

28

5

45

10-50

Informational only

No

Informational only

Approximately 28 minutes i(ncludes time required for baseline correction (required for a new assay coupon))

14

0

20

76

91 square feet

Ancillary Equipment Weight

Info Only

Power Requirements

8

Battery Supplied

Yes/No

Power Requirements

5

Expected power required

Watts

Informational only

lbs

Less than 0.5 sq. ft

Informational only No = 0; Yes = 10

About 1 lb. 10

80

10

50

Yes

10

80

Yes

10

80

#VALUE! 700+

301-700

0-300

#VALUE!

#VALUE!

User Maintenance

Info Only

Time required for Preventative Maintenance

hours per year

Informational only

Unknown

Ancillary Equipment

Info Only

List ancillary equipment requirement for operation of this instrument

List ancillary equipment

Informational only

A/C Adapter, battery charger

Storage area required for consumables

sqft

Informational only

Each kit measures 7.125 x 7.25 inches (0.36 sq. ft)

Info Only

Special conditions required for consumables (e.g. refrigeration, high humidity).

conditions

Informational only

Refrigeration

Open Architecture

Info Only

Multiple sources of consumables or self-designed assays

Reagent sources (List)

Informational only

No

Informational only

Approximately 10mL per test.

Waste Management

Info Only

Approximate volume of waste streams

Quoted Cost

Info Only

System cost as quoted or listed

$

Informational only

Purchase Cost

Info Only

Actual system cost as purchased

$

Informational only

Reagent Cost

Info Only

Reagent cost per sample

$

Informational only

Service Cost

Info Only

Cost for yearly service.

$

Informational only

Unknown

Compatibility/ Interchangeability

Info Only

Interoperability

Info Only

Types of data files for export (e.g., ASCII, XML, tab delimited text)

File types (list)

Informational only

Proprietary software required to download files.

Usability

Consumables Consumables Requirements

Approximate mL per test

Decontamination Requirements

Info Only

Is decontamination required?

Yes/No (If Yes, internal and/or external ?)

Informational only

Yes. Internal system components are exposed to test agent.

Readiness Level

Info Only

Current Technical Readiness Level

Technology Readiness Level (TRL)

Informational only

Based on SME feedback the TRL is

Costs

Score

Result

Maturity

Logistical Support

Power

Size

Run Time

Flexibility

Target Identification

Category

GRAND TOTAL #VALUE!

130


Issuu converts static files into: digital portfolios, online yearbooks, online catalogs, digital photo albums and more. Sign up and create your flipbook.