CT/GC TestingSpecimen Collection

Submission and Ordering

Objectives

• Learn about specimen collections

• Learn about specimen submissions

• Learn about specimen ordering

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CT/GC Testing• Gen-Probe/Hologic APTIMA Combo 2 Assay

– A target amplification nucleic acid probe test that utilizes target capture for the in vitro qualitative detection and differentiation of ribosomal RNA (rRNA) from Chlamydia trachomatis (CT) and/or Neisseria gonorrhoeae (GC) to aid in the diagnosis of chlamydial and/or gonococcal urogenital disease.

– FDA-cleared for male urethral and endocervical swab specimens, plus male and female first-catch urine (FCU) specimens, and in patient-and clinician-collected vaginal swab specimens.

– Turnaround Time: 2-5 days

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Specimen Collection• Acceptable Specimen Types

– Urine (Male & Female)

– Vaginal Swab

– Unisex Swab• Endocervical

• Male Urethral

• Rectal

• Must be collected using only

APTIMA Specimen Collection Kits

(see package insert for instructions)4

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CT/GC Testing: Specimen Transport

• Specimen Transport– Store specimens in their collection systems and keep at

15-30°C until shipped to ISDH

– Specimens must be transported to the ISDH Lab at 2‐30°C in Gen-Probe/Hologic urine, vaginal or unisex swab APTIMA Collection Kits.

– Specimens MUST be received at the ISDH Lab in a timely manner:

• Urine: within 30 days of collection

• Swabs: within 60 days of collection

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Common Causes of Specimen Rejection

• Mismatch of patient name/ID– Name on specimen tube and LimsNet entry don’t match

• Lack of patient identifier on specimen tube– Specimen tube is completely blank

• Specimen tube is leaking or broken

• Specimen received in Lab after:– 30 days for urine specimens– 60 days for swab specimens

• Improper specimen type

• Expired transport tube

• Multiple swabs in specimen tube

Packaging and Shipping

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• Package all specimens as UN3373 Category B,

“Biological Substance” following federal guidelines.

• ISDH Labs will provide the UN3373 mailing labels, inner and outer mailing containers and small/large Tyvek mailing evelope.– Ordering of these supplies will be done by each submitter

via LimsNet.

ISDH Shipping Containers

• 3 Components to Container– Urine/Swab collection tube (primary container)– Watertight, metal secondary container (absorbent

material NOT provided by ISDH Labs)– Rigid (cardboard) outer container

• All shipping containers are provided by ISDH Labs

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Specimen Packaging

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• Must package and ship using UN3373 Biological

Substances, Category B

• LimsNet coversheet should be wrapped around the secondary container

– Must be separated from specimen to avoid contamination

• UN3373 mailing label should be placed on the rigid outer container and the mailing envelope

• Place outer container(s) inside the Tyvek mailing envelope

– Specimens may also be shipped using just the rigid outer container as long as it contains the UN3373 mailing label

• Options– UPS *best option*

– FedEx

– U.S. Postal Service

– Courier Service

• Ship specimens to arrive at ISDH Labs on Monday-Friday, excluding holidays

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CT/GC Testing: Specimen Shipping

LimsNet Submissions

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• What is LimsNet?• ISDH Lab’s electronic specimen submission system that

allows submitters to submit lab testing requests electronically rather than with paper form

• Benefits• No need to fill out paper submission forms• Reduced turnaround time-results are available sooner-no

need to rely on faxing or mailing• Delays in testing due to incomplete patient/submitter

information are virtually eliminated• Submitters are able to view, print and save laboratory

reports as PDF files at their convenience. • Currently, 100% of CT/GC specimens submitted to ISDH

labs are via LimsNet

LimsNet Submissions

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• How to obtain a LimsNet account?• Call the ISDH Lims Help Desk at

317-921-5506 or 888-535-0011• E-mail the ISDH Lims Help Desk at

LimsAppSupport@isdh.IN.gov

• Support is available Monday – Friday from 8:15 to 4:45• http://limsnet.isdh.in.gov/

LimsNet Submissions

• Be sure that “CT/GC” is the test selected on the Log new test dropdown.

• Type in patient’s demographic

information.

• Be sure to complete items marked in red.

• Click “Save” at the bottom of the page

• Repeat for additional specimens.

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LimsNet Submissions• Be sure to fill out the

Insurance Type!– Specimens with complete billing

info will NOT be counted against your allotment!

• Select the appropriate “Reason for Test”

– MSM (urine & rectal swabs only)– Anal Risk (Female rectal swabs

only)– Routine testing

• Priority Age, Signs/Symptoms, Contact to confirmed STD, IUD, Prenatal, WIN-UPT, Test of Cure, Positive CT/GC within past 6 months.

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• Click “Submit Tests” at the top of the page.

• Check the box next to the

specimens to be shipped.

• Enter the UPS Tracking #, if

applicable.

• Click “Mark as Shipped” at the bottom of the page.

• Print LimsNet coversheet to send in with specimens.

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Submit Tests Screen

• Click on “Test Results” at the top of the page to view the status of specimens submitted.

• Enter patient search data, or use collection data to search.

• Click “Search” at the bottom of the page.

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Test Results Screen

• See the “Status” column to see if lab results are available– Unshipped

• Not yet sent to ISDH Labs

– In Transit• Sent but not yet received by

ISDH Labs

– Released• Lab report released by

ISDH Labs

• Click “View” to see a PDF of the lab report.

LimsNet Reports Screen

LimsNet: Ordering Collection & Shipping Supplies

1. Log into LIMSNET.2. On the CT/GC Request Form, click the Order Supply button.3. A new window will open displaying the Order Form .

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1. The top fields (red asterisks) will be pre-populated but are editable.2. Enter the quantity of each item needed.3. Enter a contact name, phone #, fax # and email address at your facility.4. Click the Save button. **ISDH will automatically receive your order via

email and you’ll receive a “completed” message**5. ALL ORDERS MUST BE SUBMITTED BY THE 10TH OF THE MONTH!

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Billing For Services

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Billing For Services

When you provide the patient’s insurance information and the clinic’s NPI # to ISDH through LIMSNET, the specimen submission will not be subtracted from your allotted amount of annual clinical tests provided in the STD Grant.

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Questions?

Virology/Preparedness & CT/GC Supervisor

Phone: 317-921-5843

Fax: 317-927-7804