Table 4.
Main characteristics of assays previously evaluated by CEPHIA
| Specification | Sedia™ HIV-1 Lag Avidity | BED HIV-1 incidence assay | Bio-Rad GS HIV-1/HIV-2 PLUS O EIA avidity (CDC modification) | Ortho Avidity- Vitros ECi | Ortho Less Sensitive (LS)-Vitros ECi | BioRad Geenius™ | Abbott Architect Avidity | Bio-Rad GS HIV-1/HIV-2 PLUS O EIA Avidity (Glasgow modification) | ANRS IDE-V3 | CDC multiplex |
|---|---|---|---|---|---|---|---|---|---|---|
| False recency ratio (FRR), % | 1·0 | 7·0 | 6·0 | 7·0 | 9·7 | 6·0 | 1·5 | 1·0 | 5·2 | TBD |
| Mean duration recent infection (MDRI) (days) | 188 | 302 | 333 | 285 | 285 | 179 | 128 | 88 | 216 | TBD |
| Analyte | HIV-1 antibodies | HIV-1 antibodies | HIV-1 antibodies | HIV-1 antibodies | HIV-1 antibodies | HIV-1 antibodies | HIV-1 antibodies | HIV-1 antibodies | HIV-1 antibodies | Multiple HIV antibody and antigen |
| Sample type | Serum or plasma/DBS | Serum or plasma/DBS | Serum or plasma/DBS | Serum or plasma | Serum or plasma | Serum or plasma | Serum or plasma | Serum or plasma | Serum or plasma/DBS | Serum or plasma |
| Sample volume | 40 µl total | 40 µl total | 20 µl total | 40 µl total | 40 µl total | 10 µl total | 40 µl total | 40 µl total | 10 µl total | 5 µl total |
| Infrastructure requirements | Centralized lab. Commercial assay, general lab. equipment |
Centralized lab. Commercial assay, general lab equipment |
Centralized lab. Modified commercial assay, automated platform |
Centralized lab. Modified commercial assay, automated platform |
Centralized lab. Modified commercial assay, automated platform |
Requires company supplied reader and access to software to obtain band data | Centralized lab. Modified commercial assay, automated platform |
Centralized lab. Modified commercial assay – general lab equipment |
General lab equipment – user responsible for plate manufacturer and quality control | Specialized lab equipment – user responsible for plate manufacturer and quality control |
| Storage/shipping conditions | Some reagents are stored frozen | Some reagents are stored frozen | 4–25 °C | 2–25 °C | 2–25 °C | 4–25 °C | 4–25 °C | 4–25 °C | Conjugate shipped frozen | 4 °C; calibrator and controls shipped frozen |
| Incubation temperature | 4–25 °C | 4–37 °C | 4–37 °C | Incubation within automated platform | Incubation within automated platform | 4–25 °C | Incubation within automated platform | 4–37 °C | 4–25 °C | Room temperature |
| Shelf life | >18 months | 9 months | 12 months | 12 months | 12 months | >18 months | >18 months | >18 months | 1–2 months | 12 months |
| Training | Technician proficient with 1 week's training | Technician proficient with 1 week's training and approved | Technician proficient with 1 week's training | Technician proficient with 1 week's training following company-approved course | Technician proficient with 1 week's training following company-approved course | Minimal training to conduct the assay | Technician proficient with 1 week's training following company-approved course | Technician proficient with 1 week's training | Technician proficient with 1 week's training | Technician proficient with 1 week's training |
| Regulatory pathway | Assay produced in GMP facilities and approved | Assay produced in GMP facilities and approved | None for modification. Standard assay has regulatory approval | None for modification. Standard assay has regulatory approval | None for modification. Standard assay has regulatory approval | None for modification. Standard assay has regulatory approval. | None for modification. Standard assay has regulatory approval | None for modification. Standard assay has regulatory approval | None | None |
DBS Dried blood spot; TBD, to be determined; GMP, good manufacturing practice.
Parameters chosen as representative of indicators described within target product profile (TPP). No differentiation of acceptability to TPP is given.
For consistency, FRR and MDRI calculated as per Kassanjee et al. [29]. Figures used are manufacturer/developer-described parameters without changing thresholds to improve performance. MDRI and FRR calculated without use of a recent infection testing algorithm.
MDRI and FRR estimates not shown for Centers for Disease Control and Prevention (CDC) multiplex assay due to the multiple estimates available from the different combinations of analytes and conditions available within the single assay on which to base FRR and MDRI estimates.