Transcript Competitors
Competitors Competitors: ELISA • Focus Diagnostics Dengue Fever Virus IgM Capture DxSelectTM • Focus Diagnostics Dengue Fever Virus IgG DxSelectTM Focus Diagnostics Dengue Fever Virus IgM Capture DxSelectTM • 3 hr 45 minutes incubation time (over 1 hour longer than Panbio) • 7 steps required (Panbio has 6 steps) • Has been compared to Panbio Dengue Duo IgG & IgM Capture ELISA (Cuzzubbo et al., 1999, Clin. Diagn. Lab. Immunol., 6(6):705-712.) – Overall performance of the Panbio Dengue Duo was higher than the MRL/Focus Diagnostics ELISA. – MRL/Focus Diagnostics IgM ELISA has a lower cut-off than the Duo and consequently a higher sensitivity (94% vs 89%) Focus Diagnostics Dengue Fever Virus IgM Capture DxSelectTM • Focus ELISA is less specific in infections other than dengue than the Panbio kits. – Panbio Dengue Duo 79% specificity in JE and 100% specificity in non-flavivirus infections – Focus/MRL 25% specificity in JE & 91% in non-flavivirus infections. Focus Diagnostics Dengue Fever Virus IgG DxSelectTM • 1 hr 45 minutes incubation time (Panbio only 1 hr 10 min) • 6 steps required (Panbio only has 5 steps) Competitors: Rapid test Manufacturer Description Performance UniTest (Unison Collaborative, SingaporeMalaysia) Rapid strip IgM & IgG line Diff. 1° & 2° 30 mins Serum, plasma, whole blood Pack insert exactly the same as Merlin Labs – OEM from Merlin? Merlin Dengue Fever IgG & IgM Combo Test (Merlin Labs, USA) Rapid strip IgM & IgG line Diff. 1° & 2° 30 mins Serum, plasma, whole blood 12 month exp, RT storage Inhouse study (MS) - 0% specificity for IgM (20/20 Aust blood donors came up positive) - Some strips fell apart or did not work (sample did not flow up strip) Competitors: Rapid test cont. Manufacturer Description Performance Core Dengue IgGIgM (UK) Rapid Cassette, 2 wells IgM & IgG line No 1°/2° differentiation claimed 15 minutes Serum, plasma, whole blood 24 month exp, 4 – 30°C Performance seemed OK based on small inhouse study (MG) (9/10 active dengue correct; 4/5 negs correct) Bias Dengue IgM/IgG (Millennium Biotechnology) Rapid cassette (Bidirectional) IgM & IgG line No 1°/2° differentiation Serum & whole blood 24 months exp, 8 - 30°C 5 - 30 mins Insensitive in detecting primary infection (Ong inhouse study 2004) Poor primary sensitivity & high background (MG Inhouse study, 2004 –based on 10 samples) Competitors: Rapid test cont. Manufacturer Description Performance Dengue Combo Card Test IgM & IgG line Oversensitive for IgG and under sensitive for IgM (Ong inhouse study 2004) Peerless Rapid cassette (Bidirectional) IgM & IgG line 15 – 20 mins Serum/plasma/whole blood Diff. 1° & 2° SD Dengue (Standard Diagnostics) Insensitive in detecting primary infection (Ong inhouse study 2004) Competitors: Rapid test cont. Manufacturer Description Performance Dengucheck WB IgM & IgG Pack Insert (Zephyr Biomedicals, Tulip Group) Rapid Cassette IgM & IgG line Diff. 1° & 2° 15 minutes Serum, plasma, whole blood 2 wells 24 month exp, 4 – 30°C Rec dengue envelope proteins Same product as the Core test??