GEN-PROBE APTIMA COMBO 2 TESTING FOR
NEISSERIA GONORRHEA AND CHLAMYDIA TRACHOMATIS

We are pleased to announce that APTIMA amplified probe testing will be made routinely available to our clients starting on November 18, 2002. 

Advantages of this new technology include improved sensitivity and specificity for both tested organisms.  Published sensitivity (few false negatives) for Chlamydia is 95.5% and for gonorrhea is 97.8%.  Published specificity (few false positives) for Chlamydia is 98.2% and for gonorrhea is 98.9%.

This new assay will replace our current Gen-Probe PACE assay.  Note that cultures will continue to be available for specimen types not acceptable for the Combo 2 assay and for suspected sexual abuse cases where test results may be used in legal proceedings.

An important additional advantage of this new system is the ability to perform testing on both male and female symptomatic and asymptomatic patients utilizing urine samples.  Sensitivity and specificity are equivalent to swab samples.

SPECIMEN COLLECTION - Acceptable specimen types are endocervical and male urethral swabs, and male and female symptomatic and asymptomatic urine.

Two types of collection kits are available.

The first is the "APTIMA Combo 2 Assay Unisex Specimen Collection Kit".

This kit is used to collect endocervical and male urethral swab samples.

The second collection kit is the "APTIMA Combo 2 Assay Urine Collection Kit".

Both of these kits are available from the Supply Department at RML.  They will be added to the Supply Order Form.

NOTE:  RML has validated the use of the old Gen-Probe PACE collection kits for use with the new system.  This will allow you to use your current supply of collection kits prior to utilizing the new kits.

A collection instruction poster will be sent to your account with your first shipment of the new kits.  This poster gives detailed instructions on the collection process.  If additional posters are needed, contact our Marketing Department.

For proper performance of the test, it is necessary to follow each detail of the collection process.  A couple of comments regarding the process are in order.

First, the swab collection kit contains two swabs.  The cleaning swab (white shaft) is utilized for removing excess mucous from the cervical and surrounding mucosal areas.  DISCARD THIS SWAB AFTER USE.  Specimens received with this swab must be rejected.  Use the specimen collection swab (blue shaft) to collect both the male and female specimens.  This blue swab must be submitted in the transport tube.  Transport tubes submitted without this blue swab must be rejected.  In regard to urine samples, please follow the poster guidelines to insure that a proper sample is collected.  Urine samples must be submitted in the supplied transfer tube.  RML will collect urine samples at any of our draw sites.  As in the past, swab collection must be performed in your office.  Both swab and urine samples are stable for a minimum of 30 days.

As in the past, testing for either organism or both organisms may be ordered.  RML will only perform testing on the organism ordered.

The new CPT codes for these tests are:

• Chlamydia trachomatis, amplified:  87491
• Neisseria gonorrhea:  87591

 If any questions arise concerning this change, please contact Ken VandenBosch, Technical Director.