MOLECULAR DIAGNOSTICS



Chlamydia trachomatis/ Neisseria gonorrhoeae
Enterovirus

Hepatitis C Virus (HCV)
Human Immunodeficiency Virus (HIV)
Herpes Simplex Virus (HSV)
M. tuberculosis Amplification Assay (MTD)

CHLAMYDIA TRACHOMATIS/ NEISSERIA GONORRHOEAE

Detection of C. trachomatis and N. gonorrhoeae DNA is performed using the ProbeTec Strand Displacement Amplification method (BD Biosciences). This test can be performed

on urogenital specimens (endocervical or urethral) or FIRST-VOID urine specimens.


Swab specimens should be collected using the ProbeTec collection kit (available from Central Supply). The large swab kit is for female collection and the small swab kit is for male specimen collection. Swabs must be left in the collection tube.

Detection of C. trachomatis and N. gonorrhoeae can be performed from a single specimen.
The Assay can be used as test-of-cure, but a minimum of 4 weeks after initial diagnosis is recommended before retesting.

Final Report: 24 hours

ENTEROVIRUS

Enterovirus DNA in CSF is detected using a homogeneous, 'real time' PCR assay developed and validated by the HCMC Molecular Diagnostics Laboratory. This assay

is the test of choice for diagnosisng CNS infection with this group of viruses.

CSF is the only acceptable specimen type. The assay will be run without the need for Laboratory Director's approval on specimens obtained from infants less than 1 year of age, and on specimens obtained from all other patients if the nucleated cell count in the CSF is >5 per ul. Approval will be required on specimens not meeting these criteria.

Final Report: 24 hours (May through October). 24-72 hours (November through April)

HEPATITIS C VIRUS (HCV)

HCV-PCR (QUANTITATIVE)
HCV RNA is detected and quantitated using a "real time" reverse-transcriptase PCR assay (Celera Diagnostics) whose performance characteristics have been validated by the HCMC

Molecular Diagnostics Laboratory. This assay is intended to be used both to confirm active HCV infection in seropostive individuals and to monitor therapeutic response in patients receiving antiviral therapy. Serum is the specimen of choice.


This test requires approval by the Laboratory Director if ordered by a physician other than GI or ID staff.

Final Report: 7-10 days


HCV GENOTYPE
Assay (TruGene, Visible Genetics) determines the nucleotide sequence of the PCR amplicon generated in the Roche Amplicor HCV assay, and assigns a genotype based on the result. This test is used ONLY on patients under consideration for receiving antiviral therapy for HCV infection.

This test requires approval by the Laboratory Director if ordered by a physician other than GI or ID staff.

Serum is the specimen of choice.


Final Report: 7-10 days

HUMAN IMMUNODEFICIENCY VIRUS (HIV)

HIV-PCR (QUANTITATIVE)
Assay quantitatively measures the amount of HIV-RNA in the peripheral blood (viral-load; Roche Monitor). This test is used ONLY on patients known to be infected with HIV (seropositive), and is not a test for diagnosing HIV infection.

Required specimen is anticoagulated plasma in a white PPT tube. EDTA is also acceptable.


Final Report: 7 days

HIV GENOTYPE
Nucleotide sequencing assay (TruGene, Visible Genetics) used to detect antiretroviral resistance conferring mutations in the reverse transcriptase and protease genes of HIV-1. Assay should only be used for therapeutic decision making.

Required specimen is EDTA anticoagulated plasma. Patient must have a viral load of =>1000 copies/ml for genotyping to be performed. This test requires approval by the Laboratory Director if ordered by a physician other than ID staff.

Final Report: 7-14 days

HERPES SIMPLEX VIRUS (HSV)
HSV DNA in CSF is detected using a PCR assay developed and validated by the HCMC Molecular Diagnostics laboratory. This assay is the test of choice for diagnosing CNS infection with HSV (meningitis or encephalitis).

CSF is the only acceptable specimen type. The assay will be run without the need for Laboratory Director’s approval on specimens obtained from infants less than 1 year of age, and on specimens obtained from all other patients if EITHER the nucleated cell count in the CSF is >5 per ul AND/OR the CSF protein is >45 mg/dL. Approval will be required on specimens not meeting these criteria.

Final Report: 24-72 hours

M. TUBERCULOSIS AMPLIFICATION ASSAY (MTDA)
Direct detection of M. tuberculosis complex ribosomal RNA in clinical specimens using Transcription Mediated Amplification (MTD, GenProbe).

Assay can be performed on respiratory specimens (both AFB smear positive and smear negative) without laboratory approval, and on non-respiratory specimens (requires approval of Laboratory Director).

Use of this test does not eliminate the need for AFB culture. If specimen quantities are limited, culture will receive priority.

Final Report: 24-72 hours