2016-06-20-世界卫生组织-Zika_Dx_landscape_report_7页_417kb

报告摘要

Zika Virus Diagnostic Test Summary (June 21, 2016)

This summary describes the development status and regulatory plans (as of June 21, 2016) for various molecular and immunoassay diagnostic tests for Zika virus, based on the provided information from WHO, manufacturers, and developers.

I. Lab-Based Detection: Nucleic Acid Tests (NAT)

Single-Zika Test

Focus Diagnostics: TaqMan probe-based RT-PCR test (IP Shanghai) - Developed and will evaluate in Dakar/France.
Daan Gene: RT-LAMP based kit (IP Shanghai) - Developed and will evaluate in Dakar/France.
Altona/Life: LightMix® Zika rRT-PCR Test - CE/IVD certified, Submitted to WHO EUAL.
Genekam: RealStar®Zika Virus RT-PCR Kit 1.0, careGENETM Zika Virus RT-PCR kit, ZIKV PCR kit (various) - CE/IVD certified or Submitted to WHO EUAL/CE/IVD certification/ANVISA.
Fast-track: ZIKV PCR kit - Submitted to ANVISA, Plan to submit to WHO EUAL.
Liferiver: Zika Real time PCR kit - Submitted to WHO EUAL.
WELLS BIO: careGENETM Kit - Submitted to WHO EUAL and MFDS (Korea), Plan to submit to CFDA.
Co-Diagnostics/Hologic: Aptima Zika Virus Assay - Submitted to US FDA EUA (for diagnostic use) & Plan to submit to WHO EUAL.
Theranos: TheranosTM ZIKA TNAA Assay, Aptima Zika Virus Assay - Plan to submit US FDA EUA (TNAA), Plan for CE/IVD and US FDA EUA (Aptima).
Roche: Cobas® Zika test - Approved for blood screening (US FDA IND).
Siemens/Focus: VERSANT®Zika RNA 1.0. Assay - CE/IVD certified, Submitted to US FDA EUA and WHO EUAL.
Genekam_AG: ZIKV PCR kit, AccuPower ZIK (DENV,CHIKV) Multiplex Real-Time RT-PCR Kit - Available under RUO.
Fast-track_Diag: AccuPower ZIK (DENV,CHIKV) Multiplex Kit - CE/IVD certified.
Biocartis: Gene-RADAR®Zika Virus Test - Submitted to EUAL.
Bioneer: PCR kit for ZIKV (singles or combos) - Submitted to WHO EUAL.

Multiplex Test (Simultaneous detection of ZIKV, DENV, CHIKV)

US_CDC: Trioplex rRT-PCR Kit - US FDA EUA authorized (but not commercially available).
Kit_Nat_by_Fiocruz: PCR kit for ZIKV, DENV, CHIKV (Brazil).
Focus_Diagnostics: VERSANT®Zika PCR (submitted), TaqMan test (developed).
Biocartis: Biocartis Defense Multiplex test (likely DENV/ZIKV/CHIKV) - In development.
Vela: Zika RT-PCR test (likely combo) - In development.
Thermo Fisher: PCR kit for ZIKV, DENV, CHIKV (DiaPlexQ™ ZCD).
Solgent: DiaPlexQ™ ZCD Detection Kit - Submitted to WHO EUAL.
Idylla™ (Biocartis): Idylla™ Zika, Dengue 1,2,3,4 and Chikungunya Test - Development, Plan to submit to US FDA EUA and WHO EUAL.
Biocartis: Arbovirus Tropical Fever Panel Test - Includes ZIKV, Dengue, CHIKV.
RecombiLISA (CTK Biotech): Zika IgM ELISA - Submitted to WHO EUAL.
NovaTec: NovaTec Zika Virus IgM μ-capture ELISA - CE/IVD certified, Plan to submit US FDA EUA & ANVISA.
Euroimmun: IIFT: Arbovirus Fever Mosaic2 (includes ZIKV,WNV,DENV,CHIKV) - CE/IVD certified, Approved locally (Brazil,Venezuela,...), Submitted to WHO EUAL/US FDA EUA, or seeking approval.
Euroimmun: Anti-Zika IgM + IgG ELISA - CE/IVD certified, Approved locally, Submitted to WHO EUAL/US FDA EUA, or seeking approval.
MyBiosource: ELISA kits for ZIKV (IgG/IgM) - Available under RUO.

III. Lab-Based Detection: Immunoassays

ELISA (Enzyme-Linked Immunosorbent Assay)

Euroimmun: IIFT (Immunofluorescence) Kit (ZIKV, DENV, CHIKV) - CE/IVD certified, Approved locally, Submitted Globally or seeking approval.
Euroimmun: Anti-Zika IgM + IgG ELISA - CE/IVD certified, Approved/local submissions pending.
CTK Biotech: Zika MAC-ELISA Kit (US CDC) - ELISA IgM - US FDA EUA authorized (limited use).
NovaTec/NovaTec Partner: Novagnost Zika Virus IgM μ-capture ELISA (IgM) - CE/IVD certified & Plan for IgG assay submission to US FDA EUA/ANVISA.
InBios: ZIKV DetectTM IgM Capture ELISA - Submitted to WHO EUAL (Will distribute via LF Diagnostics/IDEXX).
InBios: (VF5094) - IgM/IgG rapid test - Various distribution plans, some modified for LF testing.

Other Immunoassays

Theranos: TheranosTM ZIKA IgM Assay Kit - Plan to submit CE/IVD.
Alpha Diagnostics/Diasorin: Various IgG/IgM ELISAs (Alpha Intl Inc, Diasorin) - Development, planned submissions (US FDA EUA/Diasorin LIAISON).
Applied Biomedical: RDT for Detection of IgG and IgM (Zika) - Plan to submit WHO EUAL.
Viramed: ViraStripe® IgG, IgM Test - Likely in development or under evaluation.
Bioventive: OneStep test for Zika Virus Antibody - Development, planned submissions.

IV. Rapid Diagnostic Tests (RDTs)

Antigen/IgM/IgG Combination/Rapid Tests

Biocan: ZiZZika IgG/IgM RDT - Approved by ANVISA, CE/IVD certified, Applied in other countries.
Biocan: Zika IgG/IgM Ab/Dengue IgG/IgM Ab & NS1 Ag/Chikungunya IgG/IgM Ab Combo Rapid Test - CE/IVD certified, Seeking ANVISA approval.
Chembio: DPP® Zika Assay - Submitted to WHO EUAL.
Chembio / Bioventive: DPP® Zika/Dengue/Chikungunya Assay (IgG/IgM) - Submitted to WHO EUAL/Planned submissions (US FDA EUA/ANVISA).
NG Biotech: Rapid lateral flow assays for IgG/IgM (monovalent and multiplex) - Submitted to WHO EUAL, In development for ANVISA submission.
Alere: Lateral flow RDT for IgM/IgG and Ag detection (ZIKV) - In development, Planned submissions (WHO EUAL, US FDA EUA, CE/IVD, ANVISA).
Access Bio: Zika NS1 Test - Submitted to WHO EUAL.
BluSense: IgG/IgM RDT (Zika) - CE IVD certified.
Lumiquick: RDT (Details unclear) - CE IVD certified.
InBios International: Antigen detection test (acute/convalescent phases) - Development, Planned submissions (CE/IVD, WHO EUAL, US FDA EUA).
Co-Diagnostics/Access: Rapid immunochromatographic test kits (various variants) - Status varies, some submitted, some pending.