Genomic DNA was extracted from the submitted specimen and amplified by a multiplex polymerase chain reaction (PCR) using primers specific for the pLGV440 cryptic plasmid of region of Chlamydia trachomatis and pJD1 plasmid of Neisseria gonorrhea. Concurrently, the integrity of the extracted DNA is evaluated by the amplification of a common human housekeeping gene. PCR product identification is carried out by means of 3% agarose gel electrophoresis. This assay was developed by Access Genetics and its performance characteristics determined by West Coast Pathology Labs. It has not been cleared or approved by the U.S. Food and Drug Administration. The FDA has determined that such clearance is not necessary. This test is used for clinical purposes. It should not be regarded as investigational or for research. This laboratory is regulated under the Clinical Laboratory Improvement Amendment (CLIA) of 1988 as qualified to perform high complexity clinical testing.

The Herpes Simplex Virus (HSV) Detection and Genotyping Assay by Polymerase Chain Reaction:
HSV Detection and Genotyping Assay by PCR is a qualitative assay for the detection of HSV types 1 and 2. Detection is by Polymerase Chain Reaction (PCR) amplification of target viral DNA. A negative result may not preclude infection because results are dependent on adequate specimen collection, absence of inhibitors, and sufficient viral DNA to be detected.

Chlamydia & Gonorrhea (CT-NG):
Genomic DNA was extracted from the submitted specimen and amplified by a multiplex polymerase chain reaction (PCR) using primers specific for the pLGV440 cryptic plasmid of region of Chlamydia trachomatis and pJD1 plasmid of Neisseria gonorrhea. Concurrently, the integrity of the extracted DNA is evaluated by the amplification of a common human housekeeping gene. PCR product identification is carried out by means of 3% agarose gel electrophoresis. This assay was developed by Access Genetics and its performance characteristics determined by West Coast Pathology Labs. It has not been cleared or approved by the U.S. Food and Drug Administration. The FDA has determined that such clearance is not necessary. This test is used for clinical purposes. It should not be regarded as investigational or for research. This laboratory is regulated under the Clinical Laboratory Improvement Amendment (CLIA) of 1988 as qualified to perform high complexity clinical testing.

HPV Detection (HPV DET):
Genomic DNA was extracted from the submitted specimen and amplified by the polymerase chain reaction (PCR) using consensus oligonucleotide primers specific for the L1 region of the human papillomavirus (HPV) genome. Concurrently, the integrity of the extracted DNA was evaluated by the amplification of beta-globin, a common housekeeping gene. HPV DNA positive PCR products were subjected to digestion by the restriction endonucleases Hae III, Pst 1, and Rsa 1. Digested DNA fragments were separated on a 5% polyacrylamide gel and visualized by ethidium bromide intercalation. A digital image of the gel was captured and the specific HPV type was determined by matching the restriction fragment patterns of the respective specimens to that of known HPV restriction fragment patterns. This assay was developed by Access Genetics and its performance characteristics determined by West Coast Pathology Labs. It has not been cleared or approved by the U. S. Food and Drug Administration. The FDA has determined that such clearance is not necessary. This test is used for clinical purposes. It should not be regarded as investigational or for research. This laboratory is regulated under the Clinical Laboratory Improvement Amendment (CLIA) of 1988 as qualified to perform high complexity clinical testing.

HPV Identification (HPV ID):
Genomic DNA was extracted from the submitted specimen and amplified by the polymerase chain reaction (PCR) using consensus oligonucleotide primers specific for the L1 region of the human papillomavirus (HPV) genome (CPT code 87621). Concurrently, the integrity of the extracted DNA was evaluated by the amplification of beta-globin, a common housekeeping gene. HPV DNA positive PCR products were subjected to digestion by the restriction endonucleases Hae III, Pst 1, and Rsa 1 (CPT code 83892x3). Digested DNA fragments were separated on a 5% polyacrylamide gel (CPT code 83894x3) and visualized by ethidium bromide intercalation. A digital image of the gel was captured and the specific HPV type was determined by matching the restriction fragment patterns of the respective specimens to that of known HPV restriction fragment patterns (CPT code 83903) prior to issuance of the final report (CPT code 83912). This assay was developed by Access Genetics and its performance characteristics determined by West Coast Pathology Labs. It has not been cleared or approved by the U. S. Food and Drug Administration. The FDA has determined that such clearance is not necessary. This test is used for clinical purposes. It should not be regarded as investigational or for research. This laboratory is regulated under the Clinical Laboratory Improvement Amendment (CLIA) of 1988 as qualified to perform high complexity clinical testing.

Cystic Fibrosis (CF):
Genomic DNA extracted from the submitted sample was tested for 29 mutations located within the Cystic Fibrosis Transmembrane Regulator (CFTR) Gene.Tested mutations are detected by ARMS Allele Specific Amplification Technology (tm). Four multiplexed primer sets are subjected to polymerase chain reaction whereby a product is generated only if a mutation is present, except in the case of the??F508 normal allele. PCR product identification is carried out by means of gel electrophoresis and digital image capture. The image is analyzed for the presence of CF mutations D1152H, 1717-1G>A, G542X, W1282X, N1303K,??F508(M), 3849+10kbC>T, 621+1G>T, R553X, G551D, R117H, R1162X,??F508(N), R334W, A455E, 2183AA>G, 3659delC, 1078delT,??I507, R347P, S1251N, E60X, 3120+1G>A, 2789+5G>A, 1898+1G>A, 711+1G>T, G85E, 2184delA, 394delTT, and R560T prior to issuance of the final report. The Analyte Specific Reagents (ASRs) were developed by Orchid Diagnostics, a U.S. Food and Drug Administration (FDA) registered manufacturer of ASR's. This clinical test was developed in consultation with Access Genetics and its performance characteristics determined by Access Genetics. It has not been cleared or approved by the U.S. Food and Drug Administration. Clearance or approval for such tests is not required by the U.S. Food and Drug Administration.

Inherited Thrombophilia (IHT):
Total genomic DNA was extracted (CPT code 83890) from the submitted specimen (CPT code 83891X3) and tested for the Factor V Leiden G1691A, Prothrombin G20210A and 5, 10-methylenetetrahydrofolate reductase (MTHFR) C677T point mutations by ARMS(TM) allele specific amplification technology (CPT code 83896X4 nucleic acid technology). Two multiplexed primer sets are subjected to polymerase chain reaction (PCR) (CPT code 83901X6) to create either a normal and/or a mutation product when present. Amplified DNA fragments (CPT code 83898) were separated by electrophoresis (CPT code 83894x6, 82664X2, 83892X2) on a 3% agarose gel and visualized by ethidium bromide intercalation and a digital image was captured for review and interpretation. Each sample is analyzed for presence of normal and mutant alleles (CPT code 83903x6) prior to issuance of the final report (CPT code 83912). PCR reagents were manufactured by Tepnel Lifecodes Corporation, a U.S. Food and Drug Administration (FDA) registered manufacturer of analyte specific reagents (ASRs). This clinical test was developed and its performance characteristics determined by West Coast Pathology against testing standards in the genetic testing community and in cooperation with its participating laboratories. It has not been cleared or approved by the U.S. Food and Drug Administration. Clearance or approval for such tests is not required by the U.S. Food and Drug Administration.

Updated On: 07/26/2007