Announcement

Warde Laboratory is switching platforms for nucleic acid testing of the STI pathogens N. gonorrheae, C. trachomatis, and T. vaginalis. Starting in July/Aug 2023, this testing will be performed on the Abbott Alinity m platform using the Alinity m STI Amp Kit. All three pathogens can be detected from a single Abbott Multi-Collect tube, which Warde will provide to clients. Additional information about the new test build and ordering process will be provided over the next few months. This notice is intended to allow clients time to wind down ordering of Aptima collection tubes as they will no longer be accepted for STI nucleic acid testing.

Alinity m STI Amp Kit specimen sources and stability:

Specimen                       Room Temp Stability          Refrigerated Stability          Frozen Stability

Vaginal Swab                        14 days                                          14 days                                 60 days

Rectal Swab                           14 days                                           14 days                                 60 days

Oropharyngeal Swab           14 days                                           14 days                                 60 days

First Catch Urine                  14 days                                           14 days                                 60 days

First catch urine should be collected in an IATA screw-capped container and transferred to the Multi-Collect Tube via transfer pipet within 24 hr. No additional specimen sources or media types will be accepted for testing for these pathogens. All specimens should be shipped refrigerated.

Update Summary

Effective Date Update Type Name
07/25/2023 Inactivated/Replace Test GCRNA – “Neisseria gonorrhoeae Nucleic Acid by TMA” replaced by GCPCR – “Neisseria Gonorrhoeae Testing by PCR” Jump to update
07/25/2023 Inactivated/Replace Test CHGTM – “Chlamydia and Neisseria Nucleic Acid by TMA” replaced by COPCR – “Chlamydia and Neisseria Testing by PCR” Jump to update
07/25/2023 Inactivated/Replace Test TRIVA – “Trichomonas vaginalis RNA, Qualitative” replaced by TVPCR – “Trichomonas vaginalis Testing by PCR” Jump to update
07/25/2023 Inactivated/Replace Test CHRNA – “Chlamydia trachomatis Nucleic Acid by TMA” replaced by CHPCR – “Chlamydia Trachomatis Testing by PCR” Jump to update
07/25/2023 Inactivated Test C208E – “Allergen – Tetanus Toxoid (RC208) IgE” Jump to update
07/25/2023 Inactivated Test F281E – “Allergen – Curry (F281) IgE” Jump to update
07/25/2023 Inactivated Test F298E – “Allergen – Tragacanth (F298) IgE” Jump to update
07/25/2023 Inactivated Test F267E – “Allergen – Cardamon (RF267) IgE” Jump to update
07/11/2023 Inactivated Test NTXS – “N-telopeptide, Serum” Jump to update
07/25/2023 Updated Test HIVUL – “HIV-1 RNA Ultraquant” Jump to update
07/18/2023 Updated Test BIACT – “Bile Acids, Total” Jump to update
07/18/2023 Updated Test COATD – “Complete Atopic Dermatitis Panel” Jump to update
07/17/2023 Updated Test PARID – “Parasite Identification, Worm” Jump to update
07/11/2023 Updated Test AIRM – “Amylase Isoenzymes with Reflex to Macroamylase” Jump to update
07/11/2023 Updated Test NTXUR – “Collagen Cross Linked N Telopeptide, Urine with Creatinine” Jump to update
07/11/2023 Updated Test TSI – “Thyroid Stimulating IgG (TSI)” Jump to update
07/11/2023 Updated Test NTELO – “Collagen Cross Linked N Telopeptide (NTX), 24H U w/Creat” Jump to update

GCRNA – “Neisseria gonorrhoeae Nucleic Acid by TMA” replaced by GCPCR – “Neisseria Gonorrhoeae Testing by PCR”

Effective Date 07/25/2023
Update Type Inactivated/Replace Test
Test Update View Test Update ›

Inactivated Test Details

Mnemonic

GCRNA

Ordering Code

3091200

CPT-4 Codes(s)

87591

Replacement Test Details

Mnemonic

GCPCR

Ordering Code

3000482

CPT-4 Codes(s)

87591

Specimen Information

Collect

Variable specimen types

Specimen Preparation

Endocervical swab, first catch urine, rectal swab, oropharyngeal swab specimens.
Swab specimens must be collected using the Alinity m Multi-Collect Collection Kit. Urine specimens must be first catch and the swab can be discarded. Patients should not have urinated more than 1 hr prior to collection.

Alternate Specimen

Urine may be collected in an screw capped plastic container but must be tranferred to the Alinity m Multi-Collect Collection Kit with 24 hours.

Rejection Criteria

Specimens submitted with the white cleaning swab or with two swabs. Swabs in any media (e.g., M4, UTM, or Aptima media) other than the Alinity m Multi-Collect Collection Kit. Urine specimens where the liquid level in the urine transport tube does not fall within the clear fill window of the transport tube label (do not overfill). Urine specimens in sterile containers that have exceeded the 24 hour stability. Specimens collected in liquid cytology containers or media will not be tested.

Stability

Swab/urine in Multi-Collect
Room temperature: 14 days
Refrigerated: 14 days
Frozen: 60 days
Urine
Room temperature: Unacceptable
Refrigerated: 24 hours
Frozen: 4 days

Methodology

Polymerase Chain Reaction (PCR)
more

Reference Range

Not detected
more

Performing Laboratory

Warde Medical Laboratory
more

Interface Map for GCPCR

Test Name Ordering Code Result Code Component Name LOINC Code AOE Prompt Units
Neisseria Gonorrhoeae Testing by PCR 3000482
3000488 Specimen Source Not available Yes
3000491 Neisseria gonorrhoeae Not available No

CHGTM – “Chlamydia and Neisseria Nucleic Acid by TMA” replaced by COPCR – “Chlamydia and Neisseria Testing by PCR”

Effective Date 07/25/2023
Update Type Inactivated/Replace Test
Test Update View Test Update ›

Inactivated Test Details

Mnemonic

CHGTM

Ordering Code

3091010

CPT-4 Codes(s)

Chlamydia - 87491; Neisseria - 87591

Replacement Test Details

Mnemonic

COPCR

Ordering Code

3000499

CPT-4 Codes(s)

87491, 87591

Specimen Information

Collect

Variable specimen types

Specimen Preparation

Vaginal swab, endocervical swab, first catch urine, rectal swab, oropharyngeal swab.
Swab specimens must be collected using the Alinity m Multi-Collect Collection Kit. Urine specimens must be first catch and the swab can be discarded. Patients should not have urinated more than one hour prior to collection.

Alternate Specimen

Urine may be collected in an screw capped plastic container but must be transferred to the Alinity m Multi-Collect Collection Kit with 24 hours.

Minimum Volume

Determined by specimen type

Transport Temperature

Varies see stability

Rejection Criteria

Specimens submitted with the white cleaning swab or with two swabs. Swabs in any media (e.g., M4, UTM, or Aptima media) other than the Alinity m Multi-Collect Collection Kit. Urine specimens where the liquid level in the urine transport tube does not fall within the clear fill window of the transport tube label (do not overfill). Urine specimens in sterile containers that have exceeded the 24 hour stability. Specimens collected in liquid cytology containers or media will not be tested.

Stability

Swab/urine in Multi-Collect
Room temperature: 14 days
Refrigerated: 14 days
Frozen: 60 days
Urine
Room temperature: Unacceptable
Refrigerated: 24 hours
Frozen: 4 days

Methodology

Polymerase Chain Reaction (PCR)
more

Reference Range

Not detected
more

Performing Laboratory

Warde Medical Laboratory
more

Interface Map for COPCR

Test Name Ordering Code Result Code Component Name LOINC Code AOE Prompt Units
Chlamydia and Neisseria Testing by PCR 3000499
3000503 Specimen Source Not available Yes
3000507 Chlamydia trachomatis Not available No
3000508 Neisseria gonorrhoeae Not available No

TRIVA – “Trichomonas vaginalis RNA, Qualitative” replaced by TVPCR – “Trichomonas vaginalis Testing by PCR”

Effective Date 07/25/2023
Update Type Inactivated/Replace Test
Test Update View Test Update ›

Inactivated Test Details

Mnemonic

TRIVA

Ordering Code

3093500

CPT-4 Codes(s)

87661

Replacement Test Details

Mnemonic

TVPCR

Ordering Code

3000471

CPT-4 Codes(s)

87661

Specimen Information

Collect

Variable specimen types

Specimen Preparation

Endocervical swab, first catch urine.
Swab specimens must be collected using the Alinity m Multi-Collect Collection Kit. Urine specimens must be first catch and the swab can be discarded. Patients should not have urinated more than 1 hour prior to collection.

Alternate Specimen

Urine may be collected in an screw capped plastic container but must be transferred to the Alinity m Multi-Collect Collection Kit with 24 hours.

Minimum Volume

Determined by specimen type

Transport Temperature

Specimens in Multi-Collect tubes should be shipped refrigerated.

Rejection Criteria

Specimens submitted with the white cleaning swab or with two swabs. Swabs in any media (e.g., M4, UTM, or Aptima media) other than the Alinity m Multi-Collect Collection Kit. Urine specimens where the liquid level in the urine transport tube does not fall within the clear fill window of the transport tube label (do not overfill). Urine specimens in sterile containers that have exceeded the 24 hour stability. Specimens collected in liquid cytology containers or media will not be tested.

Stability

Swab/urine in Multi-Collect
Room temperature: 14 days
Refrigerated: 14 days
Frozen: 60 days
Urine
Room temperature: Unacceptable
Refrigerated: 24 hours
Frozen: 4 days

Methodology

Polymerase Chain Reaction (PCR)
more

Reference Range

Not detected
more

Performing Laboratory

Warde Medical Laboratory
more

Interface Map for TVPCR

Test Name Ordering Code Result Code Component Name LOINC Code AOE Prompt Units
Trichomonas vaginalis Testing by PCR 3000471
3000474 Specimen Source Not available Yes
3000481 Trichomonas vaginalis Not available No

CHRNA – “Chlamydia trachomatis Nucleic Acid by TMA” replaced by CHPCR – “Chlamydia Trachomatis Testing by PCR”

Effective Date 07/25/2023
Update Type Inactivated/Replace Test
Test Update View Test Update ›

Inactivated Test Details

Mnemonic

CHRNA

Ordering Code

3091100

CPT-4 Codes(s)

87491

Replacement Test Details

Mnemonic

CHPCR

Ordering Code

3000492

CPT-4 Codes(s)

87491

Specimen Information

Collect

Variable specimen types

Specimen Preparation

Endocervical swab, first catch urine, rectal swab, oropharyngeal swab.
Swab specimens must be collected using the Alinity m Multi-Collect Collection Kit. Urine specimens must be first catch and the swab can be discarded. Patients should not have urinated more than 1 hour prior

Alternate Specimen

Urine may be collected in an screw capped plastic container but must be transferred to the Alinity m Multi-Collect collection kit with 24 hours.

Minimum Volume

Determined by specimen type

Transport Temperature

Specimen in Multi-Collect tubes should be shipped refrigerated.

Rejection Criteria

Specimens submitted with the white cleaning swab or with two swabs. Swabs in any media (e.g., M4, UTM, or Aptima media) other than the Alinity m Multi-Collect Collection Kit. Urine specimens where the liquid level in the urine transport tube does not fall within the clear fill window of the transport tube label (do not overfill). Urine specimens in sterile in sterile containers that have exceeded the 24 hour stability. Specimens collected in liquid cytology containers or media will not be tested.

Stability

Swab/urine in Multi-Collect
Room temperature: 14 days
Refrigerated: 14 days
Frozen: 60 days
Urine
Room temperature: Unacceptable
Refrigerated: 24 hours
Frozen: 4 days

Methodology

Polymerase Chain Reaction (PCR)
more

Reference Range

Not detected
more

Performing Laboratory

Warde Medical Laboratory
more

Interface Map for CHPCR

Test Name Ordering Code Result Code Component Name LOINC Code AOE Prompt Units
Chlamydia Trachomatis Testing by PCR 3000492
3000496 Specimen Source Not available Yes
3000498 Chlamydia trachomatis Not available No

C208E – “Allergen – Tetanus Toxoid (RC208) IgE”

Effective Date 07/25/2023
Update Type Inactivated Test
Test Update View Test Update ›

Inactivated Test Details

Mnemonic

C208E

Ordering Code

3723770

CPT-4 Codes(s)

86003

F281E – “Allergen – Curry (F281) IgE”

Effective Date 07/25/2023
Update Type Inactivated Test
Test Update View Test Update ›

Inactivated Test Details

Mnemonic

F281E

Ordering Code

3723920

CPT-4 Codes(s)

86003

F298E – “Allergen – Tragacanth (F298) IgE”

Effective Date 07/25/2023
Update Type Inactivated Test
Test Update View Test Update ›

Inactivated Test Details

Mnemonic

F298E

Ordering Code

3723950

CPT-4 Codes(s)

86003

F267E – “Allergen – Cardamon (RF267) IgE”

Effective Date 07/25/2023
Update Type Inactivated Test
Test Update View Test Update ›

Inactivated Test Details

Mnemonic

F267E

Ordering Code

3723850

CPT-4 Codes(s)

86003

NTXS – “N-telopeptide, Serum”

Effective Date 07/11/2023
Update Type Inactivated Test
Test Update View Test Update ›

Inactivated Test Details

Mnemonic

NTXS

Ordering Code

3717980

CPT-4 Codes(s)

82523

HIVUL – “HIV-1 RNA Ultraquant”

Effective Date 07/25/2023
Update Type Updated Test
Test Update View Test Update ›

Specimen Information

HIV Viral Load Testing Notification

The purpose of this notification is to inform clients of an upcoming change to the HIV-1 RNA, Ultra Quantitative viral load (HIVUL) test report.
Currently, reports for specimens resulted as Not detected for HIV-1 contain the value <20 copies/mL in the HIV-1 RNA Quantitative result field, indicating a viral load below the assay limit
of detection (LOD).
In order to meet certain state reporting requirements, specimens resulted as Not detected for HIV-1 will now contain the value 0 copies/mL in the HIV-1 RNA Quantitative result field. Specimens determined to contain HIV-1 RNA will still be called Detected and the viral load will be reported in the HIV-1 RNA Quantitative result field. Specimens with very low viral loads between 1-19 copies/mL will continue to be reported as Detected with <20 copies/mL reported in the result field.
There is no change to the performance of the HIV-1 RNA assay. Results for all specimens prior to this change will remain unchanged. As indicated in the report messages, a Not detected result does not rule out infection.

Patient Preparation

Previous: Updated To:
Deleted: Added: *

BIACT – “Bile Acids, Total”

Effective Date 07/18/2023
Update Type Updated Test
Test Update View Test Update ›

Specimen Information

Patient Preparation

Previous: Updated To:
Deleted: Added: Patient should fast for eight hours prior to collection.

Collect

Previous: Updated To:
Deleted: Added: Serum separator tube (SST)

Specimen Preparation

Previous: Updated To:
Deleted: Added: Allow sample to clot completely at room temperature before centrifugation. Centrifuge and separate serum from cells and send 1.0 mL serum in a screw capped plastic vial.

Alternate Specimen

Previous: Updated To:
Deleted: Added: Serum: Red top
Added: Plasma: Lavender EDTA or Green lithium heparin

Minimum Volume

Previous: Updated To:
Deleted: Added: 0.5 mL

Transport Temperature

Previous: Updated To:
Deleted: Added: Refrigerated

Rejection Criteria

Previous: Updated To:
Deleted: Added: Hemolyzed samples or hemolysis, body fluids.

Stability

Previous: Updated To:
Added: Room temperature: 8 hours
Added: Refrigerated: 14 days
Deleted: Added: Frozen: 90 days

Methodology

Previous: Updated To:
Deleted: Added: Quantitative Enzyme Immunoassay

Reference Range

Previous: Updated To:
Deleted: Added: 0 - 10 mcgmol/L

Performing Laboratory

Previous: Updated To:
Deleted: Added: Quest SJC

COATD – “Complete Atopic Dermatitis Panel”

Effective Date 07/18/2023
Update Type Updated Test
Test Update View Test Update ›

Specimen Information

Malassezia Mix IgE/Manganese Superoxide Dismutase IgE: Result comment changes, Class discontinued – will be sent as TNP

Patient Preparation

Previous: Updated To:
Deleted: Added: *

PARID – “Parasite Identification, Worm”

Effective Date 07/17/2023
Update Type Updated Test
Test Update View Test Update ›

Specimen Information

Specimen Preparation

Previous: Updated To:
Deleted: Added: Submit worm in saline and other parasites in 70% alcohol as soon as possible in a screw capped plastic container that is leak proof. Specify specimen source.

Transport Temperature

Previous: Updated To:
Deleted: Added: Contact reference laboratory

Rejection Criteria

Previous: Updated To:
Deleted: Added: Stool sample, pinworm paddle, arthropods

AIRM – “Amylase Isoenzymes with Reflex to Macroamylase”

Effective Date 07/11/2023
Update Type Updated Test
Test Update View Test Update ›

Performing Laboratory

Previous: Updated To:
Deleted: Added: Quest SJC

NTXUR – “Collagen Cross Linked N Telopeptide, Urine with Creatinine”

Effective Date 07/11/2023
Update Type Updated Test
Test Update View Test Update ›

Performing Laboratory

Previous: Updated To:
Deleted: Added: Quest SJC

TSI – “Thyroid Stimulating IgG (TSI)”

Effective Date 07/11/2023
Update Type Updated Test
Test Update View Test Update ›

Specimen Information

Rejection Criteria

Previous: Updated To:
Deleted: Added: Gross hemolysis, lipemia, icterus, plasma.

NTELO – “Collagen Cross Linked N Telopeptide (NTX), 24H U w/Creat”

Effective Date 07/11/2023
Update Type Updated Test
Test Update View Test Update ›

Performing Laboratory

Previous: Updated To:
Deleted: Added: Quest SJC
WML Test Directory Update | July 2023 | Warde Medical Laboratory Page