Diphtheria Antibody, IgG

Label Mnemonic:	DIPTH
Epic code:	LAB3008
Downtime form:	A-1a Doctor/Provider Orders - Pathology Core and Specialty Care Nursery

Commercial Mailout Laboratory
6240-8 RCP
356-8593

Specimen(s):

Serum

Specimen Instructions:

Mark specimen clearly as "Pre-Vaccine", "Post-Vaccine", or "Random". Referral laboratory recommends that post-immunization specimen be collected 30 days after immunization. Pre-immunization sample is stored frozen for 90 days.

If the post-immunization sample is received within 90 days, the pre and post immunization samples are submitted together for testing.

If the post-immunization sample is not received within 90 days, the pre sample is removed from storage and submitted for testing.

Collection Medium:

Red top tube 5 mL (Clot Activator)

Minimum:

Adult/Pediatric Preferred Minimum: 1.0 mL serum
Absolute Minimum: 0.15 mL serum

Rejection Criteria:

Plasma or other body fluids.

Turn Around Time:

2 days upon receipt at reference laboratory

Reference Range:

Antibody concentration of > 0.1 IU/mL is usually considered 
protective.

Responder status is determined according to the ratio of a one-month, 
post-vaccination sample to pre-vaccination concentration of Diphtheria 
IgG Abs as follows:
1. If the post-vaccination concentration is less than 1.0 IU/mL, the
   patient is considered a nonresponder.
2. If the post-vaccination concentration is greater than or equal to
   1.0 IU/mL, a patient with a ratio of less than 1.5 is a
   nonresponder, a ratio of 1.5 to less than 3.0, is a weak responder,
   and a ratio of 3.0 or greater, is a good responder.
3. IF the pre-vaccination concentration is greater than 1.0 IU/mL, it
   may be difficult to assess the response based on a ratio alone.  A
   post-vaccination concentration above 2.5 IU in this case is usually
   adequate.

Comments:

Include patient immunization status on requisition.
Pre and post specimens submitted.  Post sample should be drawn 30 days 
after immunization and must be received within 60 days of pre 
sample.

Methodology:

Quantitative Multiplex Bead Assay

CPT Code:

86317