Attribute

Minimal

Ideal

Intended use

• Rapid detection of infectious diseases

• Rapid detection of specific disease/condition

Target population being tested

• General population to make informed decisions about health or during periods of heightened disease threats

• General population with special emphasis on underserved and resource limited areas

Use setting

• Home, remote-use, community centers, urgent care, mobile units, ER

• Home, remote-use, community centers, urgent care, mobile units, ER

Product description

• Small, hand-held meter and disposable test strip

• Meter price <$10

• Disposable test price <$0.50

• Multiplexing capability for 2 to 4, including controls 

• Ease of use: simple intuitive procedure with minimal training

• Ease of scale-up and manufacturing

• Battery operated meter

• Packaging: minimal, moisture proof and lightweight

• Product readily accessible through local distribution channels

• Shelf life – 3 months at RT and RH < 50%

  • Shelf life – transportation at ~ 60° C, for 24 hours, RH 60%

  • No change in performance when exposed to direct sunlight for more than 1 hour

• No meter required 

• Disposable test price < $0.50

• Multiplexing 4 to 6+ including controls

• Ease of use: simple intuitive procedure with minimal training

• Results visualization and data transfer using smart phone

• Scalable production using locally sourced material

• No power requirement

• Packaging: moisture proof, lightweight and biodegradable. 

• Available in multiple local languages, with pictorial instructions for non-literate users

• Shelf life – 24 months at RT at and RH <80%

  • Shelf life – transportation at ~ 60° C, for 24 hours, RH 80%

Performance characteristics 

• Sensitivity: > 90% for influenza / > 95% for biothreats

• Specificity: > 95% for influenza / > 98% for biothreats

• Sensitivity and specificity comparable to FDA approved methods, gold standard, and/or ability to detect targets within the diagnostic window of opportunity.

• Time to result: < 30 mins 

• Sample type(s): Easy to collect samples (capillary blood, saliva, nasal swabs)

• Prevention of sample contamination of the meter

• Sample processing: minimal

• Four or fewer steps from sample to answer

• Performance unaffected by high temperatures (40° C) and relative humidity (>85%) for 12 months

• No cold chain storage

• Sensitivity: >95% for the target analyte(s) 

• Specificity: >98% 

• Sensitivity and specificity compared to FDA approved methods

• Time to result < 10 mins 

• Sample type(s): Easy to collect samples (finger-stick blood, urine, saliva, nasal swabs)

• Ability to process multiple specimen types

• Sample processing: none

• Two steps from sample to answer

• Performance unaffected by high temperatures (40° C) and relative humidity (>85%) for 24 months

• No cold chain storage

Safety

• Must not use toxic materials in test or in sample prep

• Safe for handling in non-laboratory settings

• Safely disposable and/or easily decontaminated

• Must not use toxic materials in test or in sample prep

• Safe for handling in non-laboratory settings

• Safely disposable and/or easily decontaminated

User experience

• Simple, intuitive use

• Clear instructions for valid use

• Results are easily interpretable

• Simple, intuitive use

• Clear visual readout

• Results are easily interpretable

Regulatory and quality

• CE mark and/or FDA clearance/approval

• CLIA-waived or CLIA-waivable

• ISO 13485 certification and batch–to-batch consistency

• CE mark and FDA clearance/approval

• CLIA-waived or CLIA-waivable

• ISO 13485 certification and batch-to-batch consistency

Competitive landscape

• Lateral flow devices

• Lateral flow devices, POC molecular tests