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Test Order
Test Order
HIV-1 PCR (International Only) Qualitative CDC-10336
Synonym(s)
HIV, EID, PMTCT, Early infant diagnostic, DNA
CDC Pre-Approval Needed
Supplemental Information Required
Supplemental forms will be provided upon Pre-Approval:
- Following fields are required to be filled: Requestor (Sender POC), Address, E-Mail, Phone, Date of shipment, Number of specimens, Specimen type, Tests requested.
- All submitted specimens must include two unique specimen IDs and collection date.
Supplemental Form
ILB-160-F08E Viral Load-EID Requisition Form. Contact CDC POC to request form.
Performed on Specimens from
Human
Acceptable Sample/ Specimen Type for Testing
Dried Blood Spots (DBS)
Minimum Volume Required
At least 3 saturated 13mm circles (preferably 5) containing 70μL of whole blood including capillary blood obtained by finger/toe/heel stick which is dropped directly onto the DBS card.
Collection, Storage, and Preservation of Specimen Prior to Shipping
The appropriate anticoagulant for DBS whole blood collection is EDTA.
Dried blood spots should be kept at an ambient temperature (15 °-35 °C) for storage and shipment if testing is performed within 14 days or frozen at -70 °C if testing is not performed within 14 days.
Transport Medium
None
Specimen Labeling
This test order can accommodate diagnostic and non-diagnostic specimens. Testing subject to CLIA regulations requires two primary patient identifiers ( e.g. patient first and last name, date of birth, unique patient identifier from time of collection, such as medical record number) on the specimen container and on the test requisition.
Research or surveillance specimens may be labeled according to protocol. Labels should not include personally identifiable information. The results reported should NOT be used for diagnosis, treatment, assessment of health or management of the individual patient.
Research or surveillance specimens may be labeled according to protocol. Labels should not include personally identifiable information. The results reported should NOT be used for diagnosis, treatment, assessment of health or management of the individual patient.
Shipping Instructions which Include Specimen Handling Requirements
Refer to Dried Blood Spots for HIV Serology testing, Early Infant Diagnostics or HIV Drug Resistance Shipment information on page 5 of International Laboratory Branch Test Directory or contact CDC POC prior to submission.
Dried blood spots should be transported in a gas impermeable bag with dessicant and humidity indicator card.
For shipments that are in transit for up to 14 days, maintain at ambient temperature (15-35 °C) and shipments that are in transit for greater than 14 days, maintain temperature at -20 °C or colder with dry ice.
CDC does not accept routine shipments on weekends or holidays. Please make sure packages arrive Monday - Friday.
Ship to:
<Insert CDC Point of Contact>
Centers for Disease Control and Prevention
RDSB/STATT Unit 96
1600 Clifton Road, NE
Atlanta, GA 30329
<Insert CDC Point of Contact's Telephone Number>
All samples must be shipped in accordance with all applicable local, state and federal regulations.
Methodology
Qualitative Polymerase Chain Reaction (PCR)
Turnaround Time
4 Weeks
Interferences & Limitations
Do not use heparin as an anticoagulant. Specimen will be rejected if improperly labeled or unlabeled, without documentation or with discrepant documentation, without humidity indicators and desiccants, demonstrating any indication of humidity in the zip lock bags, insufficient volume for testing, improperly collected, containing blood clots or clumps, with a halo around the blood spot indicating contamination, if specimen are congruent or show evidence of commingling and collected onto inappropriate filter paper.
Additional Information
Contact CDC POC for turnaround times for batches with greater than 100 specimens or for batches being sent for diagnostic testing.
NOTE: If a specific testing platform is required, please contact CDC POC.
CDC Points of Contact
Version
1.7
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