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Chlamydia & Gonorrhea Testing


Influenza Testing


HSV 1 & 2 + VZV Testing


Zika Virus Testing

Use: This test is used to aid in the diagnosis of bacterial vaginosis (BV) in symptomatic women. The test detects an imbalance between Gardnerella vaginalis and Lactobacillus species by using nucleic acid amplification (NAA) technology.
Panel Code: MD75

Test Code: M201 Bacterial Vaginosis (BV) (CPT: 87511, 87798)

CPT Code: 87511, 87798
Methodology: Nucleic acid amplification (NAA)
Turnaround Time: 3-5 business days
Specimen Type: ThinPrep liquid Pap specimen
Volume: 1 ThinPrep liquid Pap specimen
Container: ThinPrep test vial
Storage & Stability: 2°C to 30°C for up to 30 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, specimens with quantity not sufficient.

Limitations: This test was developed and its performance characteristics determined by Castle Medical, LLC.
Container: Aptima® vaginal or unisex swab

Collection
(VAGINAL SWAB):
Collect vaginal fluid sample using the Gen-Probe® Aptima® swab by contacting the swab to the lower third of the vaginal wall and rotating the swab for 10 to 30 seconds to absorb fluid. Immediately place the swab into the transport tube and carefully break the swab shaft against the side of the tube. Tightly screw on the cap.

Storage Instructions: Maintain specimen at room temperature or refrigerate (2°C to 30°C). NOTE: We have the Mycoplasma genitalium nucleic acid amplification test (PCR) (M033), the panel MD28 is actually the same test. This test can be done both in urine and a swab.

URINE COLLECTION: First-void urine in Aptima® urine transport.
Volume: 2 mL of a 20 to 30 mL urine collection

Specimen Collection: The patient should not have urinated for at least one hour prior to specimen collection. Direct patient to provide a first-catch urine (approximately 20-30 mL of the initial urine stream) into a urine collection cup free of any preservatives. Collection of larger volumes of urine may result in specimen dilution that may reduce test sensitivity; lesser volumes may not adequately rinse organisms into the specimen. Female patients should not cleanse the labial area prior to providing the specimen. Add urine to the Aptima® Combo 2 urine collection device. The final volume must be between the two black lines on the device (about 2 mL).

Storage Instructions: Maintain specimen at room temperature or refrigerate (2°C to 30°C). Stable at room temperature or refrigerated for 30 days.

SWAB COLLECTION: Aptima® unisex or vaginal swab

  Vaginal Swab: Collect vaginal fluid sample using the Gen-Probe® Aptima® swab by contacting the swab to the lower third of the vaginal wall and rotating the swab for 10 to 30 seconds to absorb fluid. Immediately place the swab into the transport tube and carefully break the swab shaft against the side of the tube. Tightly screw on the cap.

  Endocervical Swab: Remove excess mucus from the cervical os and surrounding mucosa using the cleaning swab (white-shaft swab in the package with red printing). Discard this swab. Insert the specimen collection swab (blue-shaft swab in the package with green printing) into the endocervical canal. Gently rotate the swab clockwise for 10 to 30 seconds in the endocervical canal to ensure adequate sampling. Withdraw the swab carefully; avoid contact with the vaginal mucosa. Remove the cap from the swab specimen transport tube and immediately place the specimen collection swab into the transport tube. Carefully break the swab shaft at the scoreline; use care to avoid splashing of the contents. Recap the swab specimen transport tube tightly.

  Male Urethral Swab: Male urethral swab: The patient should not have urinated for at least one hour prior to specimen collection. Insert the specimen collection swab (blue-shaft swab in the package with the green printing) 2 to 4 cm into the urethra. Gently rotate the swab clockwise for two to three seconds in the urethra to ensure adequate sampling. Withdraw the swab carefully. Remove the cap from the swab specimen transport tube and immediately place the specimen collection swab into the specimen transport tube. Carefully break the swab shaft at the scoreline; use care to avoid splashing of contents. Recap the swab specimen transport tube tightly.

Storage Instructions: Maintain specimen at room temperature or refrigerate (2°C to 30°C). Stable at room temperature or refrigerated for 30 days.


Use: This test is used to detect Candida species and Candida glabrata in symptomatic women.
Panel Code: MD76

Test Code(s): M202 Candida Species, NAA (CPT: 87481); M203 Candida glabrata, NAA (CPT: 87481)

CPT Code: 87481 x 2
Methodology: Nucleic acid amplification (NAA)
Turnaround Time: 3-5 business days
Specimen Type: ThinPrep liquid Pap specimen
Container: ThinPrep test vial
Volume: 1 ThinPrep liquid Pap specimen
Minimum Volume: 1 mL of ThinPrep liquid Pap specimen
Storage & Stability: 2°C to 30°C for up to 30 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, specimens with quantity not sufficient.

Limitations: This test was developed and its performance characteristics determined by Castle Medical, LLC.

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: 3-5 business days
Specimen: Female endocervical swab and vaginal swab, male urethral swab, male and female first catch urine, Thinprep liquid cytology vial or SurePath liquid cytology vial

Volume: 1 Aptima swab (see sources above) or 1 Aptima Urine collection container
Minimum Volume: 1 Aptima swab (see sources above) or 1 Aptima Urine collection container
Container: Aptima collection devices; Thinprep or SurePath liquid cytology vial
Storage and Stability: 2°C to 30°C for up to 14 days

Limitations: Specimens collected for Chlamydia/Neisseria in Aptima collection containers cannot be used for routine chemistry or urine culture. Chlamydia/Neisseria requires use of a first catch urine.

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.
Test Code: RP08
CPT Code: 80074, 86705, 87340, 86709, 86803, 86706
Specimen: Serum or plasma
Volume: 4 mL
Container: Gel-barrier tube (preferred for serum), red-top tube or lavender-top (EDTA) tube.
Collection: If tube other than a gel-barrier tube is used, transfer separated serum or plasma to a plastic transport tube.
Storage and Stability: Room temperature. Specimen stable for 14 days at room temperature/refrigerated/frozen.

Tests Performed in Panel: Hepatitis B Core Ab, IgM | Test Code: RL56
Hepatitis B Surface Ag | Test Code: RL57
Hepatitis B Surface Ab | Test Code: RL58
Hepatitis A Ab, IgM | Test Code: RL59
Hepatitis C Virus AB | Test Code: RL60

Use: This comprehensive profile for detecting markers for HAV or HBV infections; can be used for all stages of infection.
Use: This diagnostic cascade should be used to test for, evaluate and determine the stage of infection of patients for HAV, HBV & HCV infection.
Methodology: Combination of serological Immunoassays
Test Code: MD05
CPT Code: See specific tests below
Turnaround Time: Varies
Specimen Type: Serum or Plasma
Volume: 5 mL
Minimum Volume: 4 mL

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: Refrigerate

Tests Performed in Panel: Acute Hepatitis Panel | Test Code: MD57 | CPT Code: 80074

Hepatitis A Ab, IgM with reflex | Test Code: M128 | CPT Code: 86709
  + if reactive; reflex to Hepatitis A Antibody, Total (M004)

Hepatitis B Core Ab, IgM with reflex | Test Code: M127 | CPT Code: 86705
  + if reactive; reflex to HBV Quantitation/Viral Load (MD56)
       [MD56 Test includes; Hepatitis B Virus Quant (4063) and Hepatitis B Viral Load (M006) ]
       + if 4063 HBV Quant > 500 IU/mL; reflex to Hepatitis B Virus Genotype (M126)

Hepatitis C Virus with reflex | Test Code: M129 | CPT Code: 86803
  + if reactive; reflex to HCV Quantitation/Viral Load (RP10)
       [RP10 Test includes; Hepatitis C Virus Quant (RL77) and HCV Viral Load (RL78) ]
       + if RL77 HEP C Virus Quant > 1000 IU/mL; reflex to Hepatitis C Genotype (6039)

Hepatitis B Surface Antigen | Test Code: RL57 | CPT Code: 87340
Hepatitis B Surface Antibody | Test Code: RL58 | CPT Code: 86317

Causes for Rejection: Non-EDTA plasma specimen, PST gel-barrier tube, insufficient sample volume
Use: This test is intended to be used as an aid in identifying lesions potentially caused varicella zoster virus (VZV) or herpes simplex virus (HSV) and differentiating between HSV type 1 and HSV type 2 in HSV positive samples.

Methodology: Nucleic acid amplification (NAA)
Test Code: MD08
CPT Code: 87798, 87529, 87529
Turnaround Time: 3-5 business days
Specimen Type: Swabs of lesions on skin, lips, oral, gum, tongue, anal/rectal/perineum, and genital area.
Volume: One swab
Minimum Volume: One swab
Collection Method: Swabbing of cutaneous or mucocutaneous lesions from symptomatic patients.
Container: Universal Transport Medium (UTM)
Swab Type: Standard FLOQSwab
Storage and Stability: 2°C to 30°C during transport, 2-8°C for up to 7 days.
Limitations:
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, specimen without a swab, wooden-shafted swab in transport device, and transport device with multiple swabs.
Use: 4th generation HIV-1/2 assays can detect acute HIV infection 4 to 12 days earlier than third-generation assays. Combined with supplemental tests and clinical information, this cascade can help decrease the spread of HIV infection.

Methodology: Enzyme immunoassay, potential reflex to supplementary differentiation assay, antibody typing, possible reflex to qualitative nucleic acid amplification (NAA).
Test Code:
CPT Code: 87389, when reflex testing is required additional CPT codes may apply
Turnaround Time: Varies
Specimen Type: Serum
Volume: 2-3 mL
Minimum Volume: 2 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. 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: Detection and differentiation of influenza A and influenza B virus.
Methodology: Real-time reverse-transcriptase polymerase chain reaction.
Test Code: MD16
CPT Code: 87502
Turnaround Time: Varies
Specimen Type: Nasopharyngeal swab, nasal swab, throat swab, or combined throat/nasopharyngeal swab.
Volume: 1 Swab
Minimum Volume: 1 Swab
Container: UTM collection kit, other appropriate viral transport medium
Collection Instructions: Specimen should be collected during acute phase of the disease, ideally within 24 hours of onset of symptoms. See collection package insert.
Causes for Rejection: Bacterial swab transport, grossly leaking transport container, dry specimen, specimen submitted in fixatives, specimen in other than a suitable viral transport device, specimen received after a prolonged delay, unlabeled specimen, specimen collection containers with no swabs, specimen collection containers with multiple swabs.
Use: Detection of the presence of specific viral antibodies is presumptive evidence of immunity, given the absence of clinical findings suggesting acute infection.

Test Includes: Mumps IgG Antibodies, Rubella Antibodies, Rubeola (Measles) IgG Antibodies
Methodology: EIA
Test Code: MD06
CPT Code: 86735, 86762, 86765
Turnaround Time: 3 - 5 Business Days
Specimen Type: Serum
Volume: 2-4 mL
Minimum Volume: 1.5 mL
Container: Gel-barrier tube or red-top tube
Causes for Rejection: Specimen grossly hemolyzed, gross lipemia, gross bacterial contamination
Use: 4th generation HIV-1/2 assays can detect acute HIV infection 4 to 12 days earlier than third-generation assays. Combined with supplemental tests and clinical information, this cascade can help decrease the spread of HIV infection. To test for, evaluate and determine the stage of infection of patients for HAV, HBV & HCV infection. This test is intended to be used as an aid in identifying lesions potentially caused by varicella zoster virus (VZV) or herpes simplex virus (HSV) and differentiating between HSV type 1 and HSV type 2 in HSV positive samples. To detect IgG antibodies to T. pallidum and provide serological evidence of infection with T. pallidum, the agent of syphilis. To detect Chlamydia trachomatis (CT) and/or Neisseria gonorrhoeae (GC) and/or Trichomonas vaginalis to aid in the diagnosis of chlamydial and/or gonococcal urogenital disease and/or trichomoniasis. To detect Mycoplasma genitalium. To differentiation acute from chronic or reactivated infections with Epstein-Barr virus.

Tests Performed in Panel: HIV 1/2 Screen (4th Gen) | Test Code: MD48
Hepatitis A/B/C Diagnostic Cascade | Test Code: MD05
Syphilis IgG w/rfx | Test Code: M113
HSV 1/2 Serology w/rfx | Test Code: MD58
CtNgTv Panel | Test Code: MD18
Mycoplasma genitalium | Test Code: M033
Epstein-Barr Acute Infection Panel | Test Code: MD29

Test Code: MD55
CPT Code: TBD
Turnaround Time: 3 to 5 business days

Specimen Type: Unheated Serum
First-void urine (required for Mycoplasma genitalium)

CtNgTv requires 1 of the following:
First catch urine, urine, female endocervical or vaginal swab, and male urethral swab.

Volume: Unheated Serum – 7 mL
First-void uring – 2 mL of 20 to 30 mL urine collection.
Urine and Swab – Follow collection instructions provided with the collection device

Minimum Volume: Unheated Serum – 5 mL
First-void uring – 2 mL of 20 to 30 mL urine collection.
Urine and Swab – Follow collection instructions provided with the collection device

Container: (3) SST Tubes + (2) Urine Aptima

Storage & Stability: Serum
Refrigerated for 2 days
Frozen for up to 30 days

First-void urine (Mycoplasma genitalium)
Room temperature or refrigerated for 30 days.

Urine or swab in appropriate transport tube
15 to 20C; test within 14 days
2 to 8C; test within 30 days
Frozen; test within 12 months
Use: To test for, evaluate and determine the stage of infection of patients for HAV, HBV & HCV infection. 4th generation HIV-1/O/2 assays can detect acute HIV infection 4 to 12 days earlier than third-generation assays. Combined with supplemental tests and clinical information, this cascade can help decrease the spread of HIV infection. This test is intended to be used as an aid in identifying lesions potentially caused by varicella zoster virus (VZV) or herpes simplex virus (HSV) and differentiating between HSV type 1 and HSV type 2 in HSV positive samples. To detect IgG antibodies to T. pallidum and provide serological evidence of infection with T. pallidum, the agent of syphilis.

Tests Performed in Panel: HIV 1/2 Screen (4th Gen) | Test Code: MD48
Hepatitis A/B/C Diagnostic Cascade | Test Code: MD05
Syphilis IgG w/rfx | Test Code: M113
HSV 1/2 Serology w/rfx | Test Code: MD58

Test Code: MD53
CPT Code: TBD
Turnaround Time: 3 to 5 business days
Specimen Type: HSV requires Serum (1.5 mL) - All other tests require unheated serum or plasma
Volume: 5 mL
Minimum Volume: 4 mL
Container: (3) SST Tubes

Storage & Stability: Refrigerated for 2 days
Frozen for up to 30 days
Use: 4th generation HIV-1/2 assays can detect acute HIV infection 4 to 12 days earlier than third-generation assays. Combined with supplemental tests and clinical information, this cascade can help decrease the spread of HIV infection. To test for, evaluate and determine the stage of infection of patients for HAV, HBV & HCV infection. This test is intended to be used as an aid in identifying lesions potentially caused by varicella zoster virus (VZV) or herpes simplex virus (HSV) and differentiating between HSV type 1 and HSV type 2 in HSV positive samples. To detect IgG antibodies to T. pallidum and provide serological evidence of infection with T. pallidum, the agent of syphilis. To detect Chlamydia trachomatis (CT) and/or Neisseria gonorrhoeae (GC) and/or Trichomonas vaginalis to aid in the diagnosis of chlamydial and/or gonococcal urogenital disease and/or trichomoniasis.

Tests Performed in Panel: HIV 1/2 Screen (4th Gen) | Test Code: MD48
Hepatitis A/B/C Diagnostic Cascade | Test Code: MD05
Syphilis IgG w/rfx | Test Code: M113
HSV 1/2 Serology w/rfx | Test Code: MD58
CtNgTv Panel | Test Code: MD18

Test Code: MD54
CPT Code: TBD
Turnaround Time: 3 to 5 business days

Specimen Type: HSV requires Serum (1.5 mL) - Other tests require unheated serum or plasma.
CtNgTv requires 1 of the following: First catch urine, urine, female endocervical or vaginal swab, and male urethral swab.

Volume: Unheated Serum – 5 mL
Urine and Swab – Follow collection instructions provided with the collection device

Minimum Volume: Unheated Serum – 4 mL
Urine and Swab – Follow collection instructions provided with the collection device

Container: (3) SST Tubes + (1) Urine Aptima

Storage & Stability: Serum
Refrigerated for 2 days
Frozen for up to 30 days

Urine or swab in appropriate transport tube
15 to 20C; test within 14 days
2 to 8C; test within 30 days
Frozen; test within 12 months

Use:

Test Includes: Urinalysis w/ reflex to culture, CtNgTv (Chlamydia Trachomatis, Neisseria Gonorrhoeae, Trichomonas Vaginalis), Mycoplasma genitalium
Test Code: MD52
CPT Code: 81001, 87086, 87491, 87591, 87661, 87798
Turnaround Time: N/A
Specimen Type: First catch Urine, Urine AND Swab. Female endocervical/vaginal swab. Male urethral swab.
Volume: Minimum 10 mL in sealed sterile container without preservative AND one Aptima(R) urine transport OR one Aptima(R) swab (endocervical, vaginal, or male urethral)

Storage and Stability: Ambient temperature or refrigerate

Testing Options Available:

Use: Detection of Vaginitis/Vaginosis
Test Code: MD03

Test Includes: (M081) Candida species
(M082) Gardnerella vaginalis
(M026) Trichomonas vaginalis NAA

CPT Code: 87480, 87510, 87660
Turnaround Time: Varies
Specimen Type: Vaginal Fluid
Container: BD Affirm VPIII Ambient Temp. Transport System
Collection: Swab in Affirm transport system
Storage & Stability: Ambient Temperature, refrigerated 72 hours
Causes for Rejection: Specimen collected in any transport media other than indicated; specimen older than 72 hours; specimen received with no swab.

Use: Detection of Zika virus. This test is intended for the qualitative detection of RNA from the Zika virus in serum and urine from individuals meeting CDC Zika virus clinical criteria

Test Code: MD45
CPT Code: 87798 x2
Turnaround Time: Varies
Specimen Type: Frozen serum AND frozen unpreserved urine
Volume: 1 mL serum and 1 mL urine
Container: Red-top tube or gel-barrier tube and plastic urine container without preservative

Causes for Rejection: Specimen not shipped frozen; whole blood; quantity not sufficient for analysis; gross specimen contamination; urine specimen in preservative; leaking or broken tube; submission of only one of the two required specimen types.

Methodology: Nucleic acid amplification via reverse-transcription polymerase chain reaction


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