Infectious Disease Testing Menu

Use: Detect an imbalance between Gardnerella vaginalis and Lactobacillus to aid in the diagnosis of bacterial vaginosis.
Methodology: Nucleic acid amplification (NAA)

Test Code: MD75

CPT Code: 87511, 87798
Turn-Around Time: 3-5 business days
Specimen Type: Vaginal Swab OR Cervical specimens in Thinprep liquid cytology vial

Volume: Vaginal swab using Aptima Vaginal Swab Specimen Collection Kit; OR
1 mL Cervical specimen from Thinprep liquid cytology vial transferred to an Aptima Specimen Transfer Tube

Container: Aptima Vaginal Swab Specimen Collection Kit (Cat# 301162); OR
Aptima Specimen Transfer Kit (Cat# 301154C); OR
Thinprep liquid cytology vial

Storage & Stability: 2°C to 30°C for up to 14 days

Causes for Rejection: Specimen with incorrect patient identification, unlabeled specimen, inappropriate specimen transport conditions, specimens received after prolonged delay, specimen leaked in transit, specimen in expired transport or incorrect transport device, specimens with inappropriate source for test requested, Aptima swab specimen without a swab, any non Aptima swab submitted in a Aptima transport device, wooden-shafted swab in transport device, transport device with multiple swabs, female urethral swab, bloody or grossly mucoid specimens.

Limitations: Specimen must be collected according to the instructions provided with the Aptima collection kits.


Use: Qualitative detection of Candida glabrata and Candida species by nucleic acid amplification
Test Code(s): MD76
CPT Code: 87481 x2
Methodology: Nucleic acid amplification (NAA)
Turnaround Time: 3-5 business days
Specimen Type: Vaginal swab; OR
Cervical specimens in Thinprep liquid cytology vial

Container: Aptima Vaginal Swab Specimen Collection Kit (Cat# 301162); OR
Aptima Specimen Transfer Kit (Cat# 301154C); OR
Thinprep liquid cytology vial

Volume: 1 Vaginal swab using Aptima Vaginal Swab Specimen Collection Kit; OR
1 mL Cervical specimen from Thinprep liquid cytology vial transferred to an Aptima Specimen Transfer Tube.

Minimum Volume: 1 mL of ThinPrep liquid Pap specimen
Storage & Stability: 2°C to 30°C for up to 14 days

Causes for Rejection: Specimen with incorrect patient identification, unlabeled specimen, inappropriate specimen transport conditions, specimens received after prolonged delay, specimen leaked in transit, specimen in expired transport or incorrect transport device, specimens with inappropriate source for test requested, Aptima swab specimen without a swab, any non Aptima swab submitted in a Aptima transport device, wooden-shafted swab in transport device, transport device with multiple swabs, female urethral swab, bloody or grossly mucoid specimens.

Limitations: Specimen must be collected according to the instructions provided with the Aptima collection kits.

Use: Detect an imbalance between Gardnerella vaginalis and Lactobacillus to aid in the diagnosis of bacterial vaginosis. Qualitative detection of Candida glabrata and Candida species by nucleic acid amplification
Methodology: Nucleic acid amplification (NAA)

Test Code: MD81

CPT Code: 87511, 87798 and 87481 x2
Turn-Around Time: 3 - 5 business days
Specimen: Vaginal swab; OR
Cervical specimens in Thinprep liquid cytology vial

Volume: Vaginal swab using Aptima Vaginal Swab Specimen Collection Kit; OR
1 mL Cervical specimen from Thinprep liquid cytology vial transferred to an Aptima Specimen Transfer Tube.

Container: Aptima Vaginal Swab Specimen Collection Kit (Cat# 301162); OR
Aptima Specimen Transfer Kit (Cat# 301154C); OR
Thinprep liquid cytology vial

Storage & Stability: 2°C to 30°C for up to 14 days

Limitations: Specimen must be collected according to the instructions provided with the Aptima collection kits.
Causes for Rejection: Specimen with incorrect patient identification, unlabeled specimen, inappropriate specimen transport conditions, specimens received after prolonged delay, specimen leaked in transit, specimen in expired transport or incorrect transport device, specimens with inappropriate source for test requested, Aptima swab specimen without a swab, any non Aptima swab submitted in a Aptima transport device, wooden-shafted swab in transport device, transport device with multiple swabs, female urethral swab, bloody or grossly mucoid specimens.

Tests Performed in Panel: Bacterial vaginosis (BV), NAA | Test Code: MD75
Candida vaginitis (CV) | Test Code: MD76
Use: Detect an imbalance between Gardnerella vaginalis and Lactobacillus to aid in the diagnosis of bacterial vaginosis. Qualitative detection of Candida glabrata and Candida species by nucleic acid amplification. Detection of Trichomonas vaginalis by nucleic acid amplification technology
Methodology: Nucleic acid amplification (NAA)

Test Code: MD82

CPT Code: 87511, 87798, 87481 x2 and 87661
Turn-Around Time: 3 - 5 business days
Specimen: Vaginal swab; OR
Cervical specimens in Thinprep liquid cytology vial

Volume: Vaginal swab using Aptima Vaginal Swab Specimen Collection Kit.; OR
1 mL Cervical specimen from Thinprep liquid cytology vial transferred to an Aptima Specimen Transfer Tube.

Container: Aptima Vaginal Swab Specimen Collection Kit (Cat# 301162); OR
Aptima Specimen Transfer Kit (Cat# 301154C); OR
Thinprep liquid cytology vial

Storage & Stability: 2°C to 30°C for up to 14 days

Limitations: Specimen must be collected according to the instructions provided with the Aptima collection kits.
Causes for Rejection: Specimen with incorrect patient identification, unlabeled specimen, inappropriate specimen transport conditions, specimens received after prolonged delay, specimen leaked in transit, specimen in expired transport or incorrect transport device, specimens with inappropriate source for test requested, Aptima swab specimen without a swab, any non Aptima swab submitted in a Aptima transport device, wooden-shafted swab in transport device, transport device with multiple swabs, female urethral swab, bloody or grossly mucoid specimens.

Tests Performed in Panel: Bacterial vaginosis (BV), NAA | Test Code: MD75
Candida vaginitis (CV), NAA | Test Code: MD76
Trichomonas vaginalis, NAA | Test Code: M026
Use: Detection of Chlamydia trachomatis and Neisseria gonorrhoeae by nucleic acid amplification technology
Methodology: Nucleic acid amplification (NAA)
Test Code: MD01
CPT Code: 87491, 87591, or 87801
Turn-Around Time: 2 business days
Specimen: Female or male urine; OR
Male urethral swab OR Female endocervical swab; OR
Vaginal swab; OR
Cervical specimens in Thinprep liquid cytology vial or SurePath liquid cytology vial; OR
Cervical specimens in Aptima Specimen Transfer Tube from Thinprep liquid cytology vial or SurePath liquid cytology vial

Volume: Urine to the fill-line of an Aptima Urine Specimen Transport Tube; OR
At least 2 mL urine in primary collection container; OR
1 female endocervical swab or male urethral swab using Aptima Unisex Swab Specimen Collection Kit; OR
1 Vaginal swab using Aptima Vaginal Swab Specimen Collection Kit; OR
1 mL Cervical specimen from Thinprep liquid cytology vial or SurePath liquid cytology vial transferred to an Aptima Specimen Transfer Tube; OR
1 mL Cervical specimen from Thinprep liquid cytology vial or SurePath liquid cytology vial

Container: Aptima Unisex Swab Specimen Collection Kit for Endocervical and Male Urethral Swab Specimens (Cat# 301041); OR
Aptima Vaginal Swab Specimen Collection Kit (Cat# 301162); OR
Aptima Urine Specimen Collection Kit for Male and Female Urine Specimens (Cat# 301040); OR
Aptima Specimen Transfer Kit (Cat# 301154C); OR
Thinprep liquid cytology vial or SurePath liquid cytology vial

Storage and Stability: 2°C to 30°C for up to 14 days; OR
For SurePath liquid cytology vials; 2°C to 25°C for up to 7 days.

Limitations: Specimens collected for Chlamydia/Neisseria in Aptima collection containers cannot be used for routine chemistry or urine culture. Specimen must be collected according to the instructions provided with the Aptima collection kits.

Causes for Rejection: Specimen with incorrect patient identification, unlabeled specimen, inappropriate specimen transport conditions, specimens received after prolonged delay, specimen leaked in transit, specimen in expired transport or incorrect transport device, specimens with inappropriate source for test requested, Aptima urine specimen with incorrect specimen volume, Aptima swab specimen without a swab, any non Aptima swab submitted in a Aptima transport device, wooden-shafted swab in transport device, transport device with multiple swabs, female urethral swab, bloody or grossly mucoid specimens.

Tests Performed in Panel: Chlamydia trachomatis, NAA | Test Code: R003
Neisseria gonorrhoeae, NAA | Test Code: R004
Use: Detection of Chlamydia trachomatis, Neisseria gonorrhoeae and Trichomonas vaginalis by nucleic acid amplification technology

Methodology: Nucleic acid amplification (NAA)

Test Code: MD18

CPT Code: 87491, 87591, 87661

Turn-Around Time: 2 business days

Specimen: Female or male urine; OR
Male urethral swab; OR
Female endocervical swab; OR
Vaginal swab; OR
Cervical specimens in Thinprep liquid cytology vial or SurePath liquid cytology vial; OR
Cervical specimens in Aptima Specimen Transfer Tube from Thinprep liquid cytology vial or SurePath liquid cytology vial

Volume: Urine to the fill-line of an Aptima Urine Specimen Transport Tube; OR
At least 2 mL urine in primary collection container; OR
1 female endocervical swab or male urethral swab using Aptima Unisex Swab Specimen Collection Kit; OR
1 Vaginal swab using Aptima Vaginal Swab Specimen Collection Kit.; OR
1 mL Cervical specimen from Thinprep liquid cytology vial or SurePath liquid cytology vial transferred to an Aptima Specimen Transfer Tube; OR
1 mL Cervical specimen from Thinprep liquid cytology vial or SurePath liquid cytology vial

Container: Aptima Unisex Swab Specimen Collection Kit for Endocervical and Male Urethral Swab Specimens (Cat# 301041); OR
Aptima Vaginal Swab Specimen Collection Kit (Cat# 301162); OR
Aptima Urine Specimen Collection Kit for Male and Female Urine Specimens (Cat# 301040); OR
Aptima Specimen Transfer Kit (Cat# 301154C); OR
Thinprep liquid cytology vial or SurePath liquid cytology vial

Storage and Stability: 2°C to 30°C for up to 14 days; OR
For SurePath liquid cytology vials; 2°C to 25°C for up to 7 days.

Limitations: Specimens collected in Aptima collection containers cannot be used for routine chemistry or urine culture. Specimen must be collected according to the instructions provided with the Aptima collection kits.
Causes for Rejection: Specimen with incorrect patient identification, unlabeled specimen, inappropriate specimen transport conditions, specimens received after prolonged delay, specimen leaked in transit, specimen in expired transport or incorrect transport device, specimens with inappropriate source for test requested, Aptima urine specimen with incorrect specimen volume, Aptima swab specimen without a swab, any non Aptima swab submitted in a Aptima transport device, wooden-shafted swab in transport device, transport device with multiple swabs, female urethral swab, bloody or grossly mucoid specimens.

Tests Performed in Panel: Chlamydia trachomatis, NAA | Test Code: R003
Neisseria gonorrhoeae, NAA | Test Code: R004
Trichomonas vaginalis, NAA | Test Code: M026

Use: Aid in the diagnosis of HPV. Qualitative detection of mRNA from 14 high-risk HPV types.
Methodology: Nucleic acid amplification (NAA)
Test Code: M037
CPT Code: 87624
Turnaround Time: 3 - 5 business days

Specimen Type: Cervical specimens in Thinprep liquid cytology vial or SurePath liquid cytology vial

Volume: 1 mL Cervical specimen from Thinprep liquid cytology vial or SurePath liquid cytology vial transferred to an Aptima Specimen Transfer Tube; OR
1 mL Cervical specimen from Thinprep liquid cytology vial or SurePath liquid cytology vial

Container: Aptima Specimen Transfer Kit (Cat# 301154C) OR Thinprep liquid cytology vial or SurePath liquid cytology vial

Storage and Stability: 2°C to 30°C for up to 14 days; OR
For SurePath liquid cytology vials; 2°C to 25°C for up to 7 days.

Limitations: Specimen must be collected according to the instructions provided with the Aptima collection kits.

Causes for Rejection: Specimen with incorrect patient identification, unlabeled specimen, inappropriate specimen transport conditions, specimens received after prolonged delay, specimen leaked in transit, specimen in expired transport or incorrect transport device, specimens with inappropriate source for test requested, and bloody or grossly mucoid specimens.
Use: Aids in the diagnosis of infection with HIV-1 and HIV-2. A qualitative immunoassay for the simultaneous detection of Human Immunodeficiency Virus Type 1 (HIV-1) p24 antigen (Ag) and antibodies (Ab) to HIV type 1 and Type 2 (HIV-1 and HIV-2).

Methodology: Enzyme immunoassay.
Test Code: MD48
CPT Code: 87389
Turnaround Time: 24 hr from receipt
Specimen Type: Serum
Volume: 2-3 mL
Container: Gel-barrier tube or red-top tube
Storage and Stability: 20-25°C for 48 hours and 2-8°C or frozen for 14 days.

Limitations: Reactive specimens must be investigated by additional supplemental tests not offered by Castle Medical, LLC. A negative test for an individual does not preclude exposure to or infection with HIV-1 and/or HIV-2. Negative results can occur if the quantity of the marker present in the sample is too low for detection by the assay or if the marker is not present during the stage of disease in which a sample is collected.

Causes for Rejection: Specimen aliquot not from original collection tube, specimen grossly hemolyzed, specimen received outside of specimen and/or storage and/or labeling requirements.
Use: Test for monitoring treatment response in established syphilis. When reactive, reflex to Quantitative RPR at an additional charge. RPR is a nontreponemal testing procedure for the serological detection of syphilis. Quantitative RPR is reported as a titer.

Methodology: Nontreponemal flocculation card test
Test Code: MD83
CPT Code: 86592; when reactive, CPT code 86593 is added for Quantitative RPR
Turnaround Time: 3 - 5 business days
Specimen: Unheated Serum; OR
Unheated Plasma
Volume: 5mL Serum or Plasma
Container: Red-top tube, gel-barrier tube, or lavender-top (EDTA) tube.
*If tube other than a gel-barrier tube is used, transfer separated serum or plasma to a plastic transport tube.
Storage and Stability: SERUM SPECIMEN:
2-8°C for up to five days or -20°C for long-term storage

PLASMA SPECIMEN:
2-8°C for up to 48 hours (do not freeze)

Causes for Rejection: Specimen with incorrect patient identification, unlabeled specimen, inappropriate specimen transport conditions, specimens received after prolonged delay, specimen leaked in transit, specimen in expired transport or incorrect transport device, specimens with inappropriate source for test requested, and bloody or grossly mucoid specimens.
Tests Performed in Cascade: RPR (Rapid Plasma Reagin) | Test Code: RB13 | CPT Code: 86592
When reactive, reflex at an additional charge:
Quantitative RPR Titer | Test Code: M072 | CPT Code: 86593
Use: Nontreponemal testing procedure for the serological detection of syphilis. When reactive, reflexes to Syphilis IgG immunoassay and quantitative RPR (titer) at an additional charge.

Methodology: Nontreponemal flocculation card test
Test Code: MD84
CPT Code: 86592
Turnaround Time: 3 - 5 business days
Specimen Type: Unheated Serum OR Unheated Plasma
Volume: 5mL Serum or Plasma

Container: Red-top tube, gel-barrier tube, or lavender-top (EDTA) tube. *If tube other than a gel-barrier tube is used, transfer separated serum or plasma to a plastic transport tube.

Storage & Stability: SERUM SPECIMEN:
2-8C for up to five days or -20C for long-term storage

PLASMA SPECIMEN:
2-8C for up to 48 hours (do not freeze)

Causes for Rejection: Specimen with incorrect patient identification, unlabeled specimen, inappropriate specimen transport conditions, specimens received after prolonged delay, specimen leaked in transit, specimen in expired transport or incorrect transport device, specimens with inappropriate source for test requested, and bloody or grossly mucoid specimens.

Tests Performed in Cascade: RPR (Rapid Plasma Reagin) | Test Code: RB13 | CPT Code: 86592
And when necessary (at an additional charge):
Syphilis Antibody, IgG | Test Code: M113 | CPT Code: 86780
Quantitative RPR (Titer) | Test Code: M072 | CPT Code: 86593
Use: Enzyme immunoassay for the qualitative detection of IgG antibodies to T. pallidum, to be used in conjunction with non-treponemal testing to provide serological evidence of infection with T. pallidum (the agent of syphilis). When reactive, reflexes to RPR and quantitative RPR (titer) at an additional charge.

Methodology: Enzyme immunoassay
Test Code: MD85
CPT Code: 86780
Turnaround Time: 3 - 5 business days
Specimen Type: Unheated Serum OR Unheated Plasma
Volume: 5mL Serum or Plasma

Container: Red-top tube, gel-barrier tube, or lavender-top (EDTA) tube.
*If tube other than a gel-barrier tube is used, transfer separated serum or plasma to a plastic transport tube.

Storage & Stability: SERUM SPECIMEN:
2-8C for up to five days or -20C for long-term storage

PLASMA SPECIMEN:
2-8C for up to 48 hours (do not freeze)

Limitations: 1. Results from the Syphilis IgG test should be considered in the context of all available clinical and laboratory data.

2. A non-reactive result does not preclude the possibility of:
- a very recent infection (within the last 2-3 weeks) with T. pallidum.
- an old, successfully cured infection with T. pallidum (for example >10 years previous).

3. Syphilis IgG may be reactive with sera from patients with Yaws (T. pallidum subspecies pertenue) or Pinta (T. carateum).

4. Detection of treponemal antibodies may indicate recent, past, or successfully treated syphilis infections, therefore, the test cannot be used to differentiate between active and cured cases.

5. Any sera giving reactive or equivocal results must be supplemented with a quantitative nontreponemal test (such as RPR and VDRL) to distinguish active disease and assist in ruling out false positives. This Syphilis IgG test is a treponemal assay, therefore patients with previously treated syphilis will be positive on the assay.

6. AIDS patients with impaired immunity and who are coinfected with syphilis may react falsely nonreactive in treponemal and nontreponemal tests.

7. Reactive Syphilis IgG antibody test results usually remain reactive for a lifetime, therefore antibody indices cannot not be used to determine response to therapy.


Causes for Rejection: Specimen with incorrect patient identification, unlabeled specimen, inappropriate specimen transport conditions, specimens received after prolonged delay, specimen leaked in transit, specimen in expired transport or incorrect transport device, specimens with inappropriate source for test requested, and bloody or grossly mucoid specimens.

Tests Performed in Cascade: Syphilis Antibody, IgG | Test Code: M113 | CPT Code: 86780
And when necessary (at an additional charge):
RPR (Rapid Plasma Reagin) | Test Code: RB13 | CPT Code: 86592
Quantitative RPR (Titer) | Test Code: M072 | CPT Code: 86593

Use: Detection of Trichomonas vaginalis by nucleic acid amplification technology
Methodology: Nucleic acid amplification (NAA)
Test Code: M026
CPT Code: 87661
Turnaround Time: 2 business days

Specimen Type: Female or male urine; OR
Male urethral swab OR Female endocervical swab; OR
Vaginal swab OR Cervical specimens in Thinprep liquid cytology vial or SurePath liquid cytology vial; OR
Cervical specimens in Aptima Specimen Transfer Tube from Thinprep liquid cytology vial or SurePath liquid cytology vial

Volume: Urine to the fill-line of an Aptima Urine Specimen Transport Tube; OR
At least 2 mL urine in primary collection container; OR
1 female endocervical swab or male urethral swab using Aptima Unisex Swab Specimen Collection Kit; OR
1 Vaginal swab using Aptima Vaginal Swab Specimen Collection Kit; OR
1 mL Cervical specimen from Thinprep liquid cytology vial or SurePath liquid cytology vial transferred to an Aptima Specimen Transfer Tube; OR
1 mL Cervical specimen from Thinprep liquid cytology vial or SurePath liquid cytology vial

Container: Aptima Unisex Swab Specimen Collection Kit for Endocervical and Male Urethral Swab Specimens (Cat# 301041); OR
Aptima Vaginal Swab Specimen Collection Kit (Cat# 301162); OR
Aptima Urine Specimen Collection Kit for Male and Female Urine Specimens (Cat# 301040); OR
Aptima Specimen Transfer Kit (Cat# 301154C) OR Thinprep liquid cytology vial or SurePath liquid cytology vial

Storage and Stability: 2°C to 30°C for up to 14 days; OR
For SurePath liquid cytology vials; 2°C to 25°C for up to 7 days.

Limitations: Specimens collected for Trichomonas vaginalis in Aptima collection containers cannot be used for routine chemistry or urine culture. Specimen must be collected according to the instructions provided with the Aptima collection kits.

Causes for Rejection: Specimen with incorrect patient identification, unlabeled specimen, inappropriate specimen transport conditions, specimens received after prolonged delay, specimen leaked in transit, specimen in expired transport or incorrect transport device, specimens with inappropriate source for test requested, Aptima urine specimen with incorrect specimen volume, Aptima swab specimen without a swab, any non Aptima swab submitted in a Aptima transport device, wooden-shafted swab in transport device, transport device with multiple swabs, female urethral swab, bloody or grossly mucoid specimens.
Use: Identify bacteria and fungi associated with UTI by nucleic acid amplification. Identify antibiotic resistance genes by nucleic acid amplification.
Methodology: Nucleic acid amplification
Test Code: UTI
Turnaround Time: 2 business days
Specimen Type: Urine

Volume: wo – 9mL tubes of urine preferred.
5mL minimum

Container: Urine in boric acid tube

Storage & Stability: 2-8˚C and test within 72 hours from collection

Causes for Rejection: Specimen with incorrect patient identification, unlabeled specimen, inappropriate specimen transport conditions, specimens received after prolonged delay, specimen leaked in transit, specimen in expired transport or incorrect transport device, specimens with inappropriate source for test requested, and bloody or grossly mucoid specimens.


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