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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



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Cranford Patient Service Center
27 South Avenue West, Cranford, NJ 07016
Phone: (908) 441-7710
Fax: (908) 441-7711
Hours:

Monday, Tuesday, Wednesday: 7:00 AM - 6:00 PM

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Irvington Patient Service Center
40 Union Avenue, Suite 205, Irvington, NJ 07111
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Monday, Tuesday, Friday   : 9:00 AM - 5:00 PM

Wednesday                     : 9:00 AM - 6:00 PM

Thursday                        : CLOSED


Linden Patient Service Center
1901 East Linden Avenue, Unit 25, Linden, NJ 07036
Phone: (908) 474-1004
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Monday - Friday   :     8:00 AM - 2:00 PM

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Somerset Patient Service Center
1553 Rt.27, Somerset, NJ 08873
Phone: (609) 527-9192
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Succasunna Patient Service Center
225 State Route 10, Succasunna, NJ 07876
Phone: (973) 971-9314
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Monday - Friday   :   9:00 AM - 5:00 PM


Voorhees Sheppard Patient Service Center
903 Sheppard RD., Voorhees, NJ 08043
Phone: (856) 528-5915
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Monday - Friday   :   8:00 AM - 5:00 PM


Voorhees White Horse Patient Service Center
1307 White Horse Rd., Suite A100, Voorhees, NJ 08043
Phone: (856) 454-5128
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Monday - Friday   :     8:00 AM - 5:00 PM



Stamford Patient Service Center
111 High Ridge Road, First Floor, Stamford, CT 06905
Phone: (908) 583-6632
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Mon, Wed, Fri: 9:00 AM - 3:00 PM

Tuesday        : CLOSED

Thursday      : CLOSED

Lunch Break : 12:00 PM - 12:30 PM



Baltimore Patient Service Center
3455 Wilkins Avenue, Suite L10-A, Baltimore, MD 21229
Phone: (410) 644-4444
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Monday - Friday   :     8:00 AM - 4:00 PM


Cambridge Patient Service Center
503 Byrn Street, 2nd Floor, Cambridge, MD 21613
Phone: (443) 477-6568
Fax: (443) 477-6530
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Monday - Friday   :     6:00 AM - 1:00 PM

 


Germantown Patient Service Center
19785 Crystal Rock Drive, Suite 209, Germantown, MD 20874
Phone: (240) 247-0345
Fax: (240) 247-0344
Hours:

Mon - Fri: 7:30 AM - 6:00 PM

 


Greenbelt Patient Service center
7525 Greenway Center Drive, Suite T9, Greenbelt, MD 20770
Phone: (856) 454-5218
Fax: (856) 454-5136
Hours:

Monday -  Tuesday  :     7:00 AM - 5:00 PM

Wednesday             :     7:00 AM - 7:00 PM

Thursday                :     7:00 AM - 5:00 PM

Friday                     :     7:00 AM - 6:00 PM

Saturday                 :     8:00 AM - 4:00 PM


West Diamond Ave Patient Service Center
806 W Diamond Avenue, Suite 100, Gaithersburg, MD 20878
Phone: (734) 212-8192
Hours:

Monday - Friday   :     7:30 AM - 6:00 PM


5th Avenue Patient Service Center
5908 5th Avenue, Brooklyn, NY 11220
Phone: (718) 880-9970
Fax: (718) 880-9970
Hours:

Monday - Thursday :  10:00 AM-6:00 PM

Friday                    :  10:00 AM-1:00 PM

Saturday                :  10:00 AM-6:00 PM


Brooklyn Patient Service Center
7510 4th Avenue, STE 4, Brooklyn, NY 11209
Phone: (718) 238-2034
Fax: (718) 833-3846
Hours:

Monday - Friday    :  8:00 AM-5:00 PM

Saturday                :  8:00 AM-1200 PM

Sunday                  :  Closed


First Medcare
8707 Flatlands Avenue, Lower Level, Brooklyn, NY 11236
Phone: (718) 210-1909
Fax: (718) 210-1910
Hours:

Monday, Tuesday, Thursday, Friday: 8:00 AM - 4:30 PM

Wednesday :                                 10:00 AM - 6:00 PM

 

 


New Hyde Park Patient Service Center
1575 Hillside Avenue, New Hyde Park, Suite 100-A, NY 11040
Phone: (516) 500-1047
Hours:

Monday - Friday :  7:30 AM-4:00 PM


Rockville Centre Patient Service Center
178 Sunrise Hwy, Lower Level, Rockville Centre, NY 11570
Phone: (516) 442-0417
Fax: (516) 442-0418
Hours:

Monday - Friday  :    7:00 AM-7:00 PM

Saturday            :     8:00 AM-2:00 PM

 



Medical Drive Patient Service Center
1314 Medical drive, Suite 101, Fayetteville, NC 28304
Phone: (910) 491-5253
Hours:

Monday - Thursday   :    8:00 AM - 5:00 PM

Friday                     :     8:00 AM - 2:00 PM


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

Monday - Friday   :     8:00 AM - 6:00 PM


Walter Reed Patient Service Center
1220 Walter Reed Road, Suite A, Fayetteville, NC 28304
Phone: (910) 481-1956
Hours:

Monday - Thursday   :     7:00 AM - 4:00 PM

Friday                      :     8:00 AM - 2:00 PM



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

Monday - Friday   :   8:00 AM - 1:00 PM


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

Monday - Friday   :   8:00 AM - 4:00 PM


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

Monday - Friday   :   7:00 AM - 3:00 PM



ACCU Reference Louisiana Stat LAB
1532 River Oaks Road W., New Orleans, LA 70123
Phone: (504) 779-8163
Fax: (504) 779-8164
Hours:

Monday-Friday   :     7:00 AM - 4:00 PM


Metairie Patient Service Center
4213 Saxon Street, Suite #100, Metairie, LA 70006
Phone: (504) 516-2461
Hours:

Monday-Friday   :     7:00 AM - 4:00 PM



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