Table 3 Finalized TPP for a multi-parameter cardiometabolic POC device
From: Development of a target product profile for a point-of-care cardiometabolic device
# | Characteristic | Min/Opt | Requirements |
|---|---|---|---|
General | |||
1 | Intended use | Minimal | Intended for basic screening, diagnosis and management of cardiometabolic disorders (e.g. hyperlipidaemia, diabetes and renal function) and also managing people at high cardiovascular risk; excluding neonates |
1a | Optimal | Same as minimal, plus offering an expanded test menu to address a wider range of cardiometabolic disorders (e.g. liver function, acute cardiac care); including neonates | |
2 | Description of device | Minimal | Benchtop (or hand-held) instrument designed for use in combination with self-contained, disposable assay cartridge(s) or strips containing all required reagents to execute a test from sample to result |
2a | Optimal | Same as minimal | |
3 | Target use setting | Minimal | Level 1 healthcare facility (primary care) defined as having a rudimentary equipped laboratory, water, electricity with intermittent surges and/or outages, limited climate control, dusty environment; medical staff onsite |
3a | Optimal | Level 0 healthcare facility without equipped laboratory, electricity with frequent surges and/or outages, no climate control, dusty environment; includes mobile testing facilities; medical staff onsite | |
4 | Target operator | Minimal | Minimally skilled healthcare worker e.g. with basic laboratory training (device-specific training provided) |
4a | Optimal | Healthcare worker without specific laboratory training (capable of applying device-specific training) | |
Device | |||
5 | Device design | Minimal | Device with single port capable of interfacing with one cartridge design or strip |
5a | Optimal | Device with several ports capable of interfacing with one or more cartridge designs or strips for simultaneous, independent detection of multiple analytes; possibility for modular connectivity of several devices | |
6 | Size | Minimal | Small, table-top device (no larger than 50 × 70 × 50 cm) |
6a | Optimal | Smaller than minimal and portable | |
7 | Weight | Minimal | ≤ 10 kg |
7a | Optimal | ≤ 2 kg | |
8 | Power requirements | Minimal | Local 110–220 V AC mains power, plus uninterruptible power supply (UPS) to complete current cycle; UPS and circuit protector must be integrated within the system |
8a | Optimal | Same as minimal, with rechargeable battery back-up (8-h operation) or single-use battery (for hand-held) | |
9 | Throughput | Minimal | Throughput processing of one sample at a time; minimum of 10 samples per hour when individual analytes are tested or 4 samples per hour when analyte panels are tested |
9a | Optimal | More than one sample at a time with random access and the ability to test different analytes simultaneously | |
10 | Environmental Stability: operating range of the device | Minimal | Operation at 10–40 °C and up to 90% non-condensing humidity at an altitude up to 2500 m; able to function in direct sunlight; able to withstand dusty conditions; water splash proof |
10a | Optimal | Operation at 5–45 °C and up to 98% non-condensing humidity at an altitude up to 3000 m; able to function in direct sunlight; able to withstand dusty conditions; water splash proof | |
11 | Biosafety | Minimal | Closed, self-contained system with unprocessed sample transfer; easy decontamination of instrument surfaces |
11a | Optimal | Same as minimal | |
12 | Training time needed | Minimal | Below 1 day for a healthcare worker to operate the device |
12a | Optimal | Below 2 h for a healthcare worker without basic laboratory training to operate the device | |
13 | Service, maintenance and calibration | Minimal | Weekly maintenance (< 30 min, with hands on time < 10 min); mean time between failures of at least 24 months or 10,000 tests; self-check alerting operator to instrument errors or warnings; operator calibration per new lot or at set time intervals |
13a | Optimal | Weekly maintenance (< 30 min, with hands on time < 10 min); mean time between failures of at least 36 months or 30,000 tests; self-check alerting operator to instrument errors or warnings; ability to be calibrated remotely or no calibration needed (factory calibrated) | |
14 | Patient identification capability | Minimal | Manual entry of alphanumeric patient identifier via keypad, touchscreen or connected result management device (e.g. smartphone) |
14a | Optimal | Same as minimal, plus bar code, radio frequency identification (RFID) or other reader | |
15 | Result output | Minimal | Quantitative based on the analytes of detection; qualitative where this is sufficient to inform clinical decision making |
15a | Optimal | Quantitative plus option of qualitative readout where that result is sufficient to inform clinical decision-making; ability to select which test results are reported to the user | |
16 | Data display | Minimal | On-device visual readout with ability to function in various lighting conditions ranging from bright to low ambient light conditions; ability to add information (patient ID, operator ID, date, location, etc.) |
16a | Optimal | Same as minimal, with option to add custom result ranges and alerts to support clinical decision-making by medical staff | |
17 | Connectivity | Minimal | Ability to connect to a mobile network, or Wifi or use a USB for data transfer |
17a | Optimal | Same as minimal, including bluetooth and bi-directional communication | |
18 | Data export and protection | Minimal | Secured data export with end-to-end encryption connectivity to external printer; passcode-protected machine access |
18a | Optimal | Same as minimal, plus scheduled/automatic data export using interoperable standards; support of any or all of the following formats: HL7, FHIR, ASTM, JSON; passcode-protected individual user access | |
19 | Memory | Minimal | 500 patient results, 100 quality control (QC) results |
19a | Optimal | 10,000 patient results, 20,000 QC results or unlimited data storage (cloud-based) | |
20 | Manufacturing | Minimal | International Organization for Standardization (ISO) 13,485:2016 compliant |
20a | Optimal | Same as minimal | |
21 | List price of the device | Minimal | ≤ 1,500$ (USD) |
21a | Optimal | ≤ 300$ (USD) | |
22 | Device regulatory status | Minimal | Approval through at least one Stringent Regulatory Authority (http://www.stoptb.org/assets/documents/gdf/drugsupply/List_of_Countries_SRA.pdf) |
22a | Optimal | Same as minimal plus CLIA-waived; WHO-PQ approval if requirements are in place | |
Test cartridge/strip | |||
23 | Analytes/test menu | Minimal | Glucose, HbA1c, lipids (total cholesterol and HDL to calculate non-HDL cholesterol), creatinine |
23a | Optimal | Same as minimal and full lipid profile (values for cholesterol, HDL, LDL and triglycerides), liver enzymes (ALT, AST, ALP, GGT, bilirubin), troponin, BNP, ACR, auto calculation of eGFR and others as required for wider cardiometabolic disease management | |
24 | Description of test cartridge/strip | Minimal | Self-contained, disposable cartridge(s)/strips containing all required reagents, buffers or other consumables to execute a test from sample to result |
24a | Optimal | Same as minimal | |
25 | Multiplexing of simultaneous tests | Minimal | Testing of one analyte at a time in single or multi-analyte panel cartridge |
25a | Optimal | Testing of several analytes in parallel, either with multi-analyte panel cartridge, or with several cartridge/strip ports; ability to measure analytes individually, as well as part of a panel | |
26 | Additional third party consumables | Minimal | None, except for sample collection |
26a | Optimal | None; manufacturer-provided kits contain all required items for sample collection and testing | |
27 | Specimen type | Minimal | Ability to accept one specimen type per cartridge/strip (whole blood or plasma or serum or urine, depending on the parameter) |
27a | Optimal | Ability to accept different specimen types per cartridge/strip (whole blood, plasma, serum, urine; non-exclusive with exception of parameter dependency on sample type) | |
28 | Sample volume | Minimal | Minimum sample volume required to reach clinically relevant sensitivities for each test; no more than 50 μl per parameter for fingerstick whole blood (cumulative volume for panel cartridges) |
28a | Optimal | Same as minimal | |
29 | Accuracy | Minimal | Equivalent to state of the art reference assays for the same target analytes; where applicable, clinically relevant LODs are to be met; for troponin, rule-out of myocardial infarction according to ACC/AHA guidelines |
29a | Optimal | Same as minimal; for troponin: rule-out of myocardial infarction according to ESC 2018 guidelines | |
30 | Interfering substances | Minimal | Interference testing should follow CLSI EP37 list of recommended substances |
30a | Optimal | Same as minimal | |
31 | Standardization and traceability | Minimal | Test should be standardized based on established methods (e.g. isotope dilution mass spectrometry, ID-MS) and traceable to internationally recognised reference materials (where available) |
31a | Optimal | Same as minimal | |
32 | Test result | Minimal | Quantitative result based on the analytes of detection. Qualitative result available to clinician where that result is sufficient to inform clinical decision-making |
32a | Optimal | Same as minimal | |
33 | Controls | Minimal | External positive and negative controls to be run with each new lot and every week |
33a | Optimal | External positive and negative controls to be run with each new lot and every month | |
34 | Environmental stability: transport | Minimal | No cold chain required; should be able to tolerate stress during transport (cycles of temperature of 30 to 50 °C) without affecting the labelled expiry date |
34a | Optimal | Same as minimal | |
35 | Environmental Stability: Reagent shelf life | Minimal | 18 months at 2–35 °C (including 3 months at 40 °C); 90% relative humidity |
35a | Optimal | 24 months at 2–40 °C; up to 98% relative humidity | |
36 | Environmental Stability: Operating range | Minimal | 10–40 °C; 90% relative humidity |
36a | Optimal | 5–45 °C; 98% relative humidity | |
37 | Waste/disposal Requirements | Minimal | No components that are classified with a GHS[1] classification—H(2) that would require waste disposal with high temperature incinerator (or more than a De Monfort type incinerator) |
37a | Optimal | Same as minimal | |
38 | Manufacturing | Minimal | International Organization for Standardization (ISO) 13,485:2016 compliant |
38a | Optimal | Same as minimal | |
39 | Reagent regulatory status | Minimal | Approval through at least one Stringent Regulatory Authority (http://www.stoptb.org/assets/documents/gdf/drugsupply/List_of_Countries_SRA.pdf) |
39a | Optimal | Same as minimal plus CLIA-waived; WHO-PQ approval if requirements are in place | |
40 | List price of assay cartridge/strips | Minimal | Strips: ≤ 1$ (USD); cartridges: ≤ 3$ (USD) per analyte (individual or as part of a panel) |
40a | Optimal | Strips: ≤ 0.5$ (USD); cartridges: ≤ 1$ (USD) per analyte (individual or as part of a panel) | |
41 | Distribution territory | Minimal | Worldwide |
41a | Optimal | Same as minimal |