Laboratory Test Directory


Code

Name



Zika Virus Assays Authorized for Emergency Use

2016-08-26 06:00:00


On February 26, 2016, Sylvia Burwell, Secretary of Health and Human Services (HHS), decided that Zika virus had significant potential to cause a public health emergency that might affect national security or the health and security of United States citizens living abroad. The Secretary of HHS then declared that circumstances existed to justify authorization of the emergency use of in vitro diagnostics for detection of Zika virus and/or diagnosis of Zika virus infection.

Since that time, FDA has issued an Emergency Use Authorization (EUA) for the emergency use of seven different assays for the qualitative detection of RNA from Zika virus in human serum, plasma, urine. The seven molecular assays and their approval dates are listed below:

 

  • xMAP multiflex Zika RNA Assay (Luminex), August 4, 2016
  • Versant Zika RNA 1.0 Assay (kPCR) kit (Siemens Healthcare Diagnostics Inc), July 29, 2016
  • Viracor-IBT Laboratories, Inc. Zika Virus Real-time RT-PCR test , July 19, 2016
  • Aptima Zika Virus Assay (Hologic, Inc), July 17, 2016
  • RealStar Zika Virus RT-PCR kit U.S. (Altona Diagnostics), May 13, 2016
  • Zika Virus RNA Qualitative Real-Time RT-PCR (Focus Diagnostics), April 28, 2016
  • Zika MAC-ELISA (CDC), February 26, 2016
  • Trioplex Real-time RT-PCR assay (CDC), March 17, 2016

 

 

These assays can be used by laboratories in the United States that are certified under CLIA 1988 to perform high complexity tests or similarly qualified non-U.S. laboratories. The Viracor test is limited to testing in their own facility. Testing should be limited to detection of Zika virus in specimens collected from individuals meeting the Centers for Disease Control and Prevention's clinical criteria and/or epidemiological criteria for Zika virus infection.

 

FDA has also issued an EUA for the CDC’s Zika Immunoglobulin M (IgM) Antibody Capture Enzyme-Linked Immunosorbent Assay (Zika MAC-ELISA) for the presumptive detection of Zika virus-specific IgM in human sera or cerebrospinal fluid. Testing can be performed by qualified laboratories designated by CDC and certified by CLIA 1988.

 

Reference:

http://www.fda.gov/MedicalDevices/Safety/EmergencySituations/ucm161496.htm



Make a Payment

To make our medical lab services easier to use we now offer a secure online payment service.

Home Visit Requisition Form

To request a home care services or to obtain more information on Accu reference medical lab, please complete an Home Visit Requisition Form

Career Opportunities

We are always interested in expanding our professional team. If you'd like to be considered for a position, send us your resume

E-Forms

This section contains e-forms. The forms may be printed and mailed or faxed.


Find a Location

East Orange Patient Service Center
108 South Munn Ave, East Orange, NJ 07018
Phone: (862) 233-6611
Hours:

10:00 AM-5:00 PM


Glassboro Patient Service Center
359 N Main Street, Glassboro, NJ 08028
Phone: (856) 881-5320
Hours:

7:30 AM-3:30 PM


Irvington Patient Service Center
40 Union Avenue, Suite 205, Irvington, NJ 07111
Phone: (862) 231-6223
Hours:

9:00 AM - 6:00 PM
CLOSED THURSDAYS AND WEEKENDS


Jersey City Patient Service Center
709 Newark Ave 2nd Floor, Jersey City, NJ 07036
Phone: (201) 222-0178
Hours:

9:00 AM - 5:00 PM


Linden Patient Service Center
1901 East Linden Avenue, Unit 25, Linden, NJ 07036
Phone: (908) 474-1004
Hours:

8:00 AM - 2:00 PM
CLOSED WEEKENDS


Somerset Patient Service Center
1553 Rt.27, Somerset, NJ 08873
Phone: (609) 528-9199
Hours:

9:00 AM - 6:00 PM
CLOSED WEEKENDS



Stamford Patient Service Center
111 High Ridge Road, First Floor, Stamford, CT 06905
Phone: (908) 583-6607
Fax: (908)224-9700
Hours:

9:00 AM - 3:00 PM

CLOSED WEDNESDAY, WEEKENDS



Baltimore Patient Service Center
3455 Wilkins Avenue, Suite L10-A, Baltimore, MD 21229
Phone: (410) 644-0075
Hours:

9:00 AM-3:39 PM


Brooklyn Patient Service Center
5908 5th Avenue, Suite 6, Brooklyn, NY 11220
Phone: (718) 439-8200
Hours:

9:00 AM-5:00 PM


Chappaqua Service Center
175 King Street, Chappaqua, NY 10514
Phone: (914)861-2439
Fax: (914)861-2440
Hours:

Monday, Wednesday 8:00 AM - 12:00 PM

Thursday, Friday       8:00 AM - 4:00 PM

CLOSED TUESDAY, WEEKENDS

 


New Hyde Park Patient Service Center
1575 Hillside Avenue, New Hyde Park, NY 11040
Phone: (516) 500-1047
Hours:

7:30 AM-4:00 PM



Medical Drive Patient Service Center
1314 Medical drive, Suite 101, Fayetteville, NC 28304
Phone: N/A
Hours:

8:30 AM-4:30 PM


Payetteville Patient Service Center I
1905 Skibo Road, Suite 101, Fayetteville, NC 28314
Phone: (910) 867-7071
Hours:

9:00 AM-6:00 PM


Walter Reed Patient Service Center
1220 Walter Reed Road, Suite A, Fayetteville, NC 28304
Phone: (910) 491-1956
Hours:

7:00 AM - 4:00 PM



Bangor Patient Service Center
225 Erdman Avenue, Bangor, PA 18013
Phone: (610) 452-9174
Hours:

7:00 AM- 3:00 PM


Hazelton Patient Service Center
101 South Church Street, Hazelton, PA 18704
Phone: (570) 455-0747
Hours:

8:00 AM - 4:00 PM


Kingston Patient Service Center
517 Pierce Street, Kingston, PA 18704
Phone: (570) 283-0674
Hours:

7:00 AM - 3:00 PM


Nanticoke Patient Service Center
233 South Prospect Street, Nanticoke, PA 18634
Phone: (570) 735-2626
Hours:

7:00 AM - 1:00 PM



Conlin Patient Service Center
4420 Conlin Street, Ste#100, Metairie, LA 70006
Phone: (504) 302-2035
Hours:

8:00 AM - 5:00 PM


Saxon Patient Service Center
4213 Saxon Street, Metairie, LA 70006
Phone: (504) 779-8163
Hours:

7:00 AM - 4:00 PM


West Bank Patient Service Center
1799 Stumpf blvd, Gretna, LA 70056
Phone: (504) 301-1817
Hours:

N/A



Have questions or need assistance? Call (877) 733-4522