working together to bring you the latest advances in ...all tests performed onsite at medical...
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All tests performed onsite at Medical Diagnostic Laboratories, L.L.C.
Working together to bring you the latest advances in molecular diagnostic testing…
• Comprehensive,fullcolorreportincludedwitheachresult• Patient-specifichistorytrendreports• Highlyskilled,boardcertifiedpathologists• Over30moleculardiagnostictestsavailableofftheThinPrep®
• Over70moleculardiagnostictestsavailableofftheOneSwab®
• 24-72hourturnaroundtime• Automaticallygenerated,monthlyPapresultsummaryreports
MedicalDiagnosticLaboratories,L.L.C.
Upd:7/2018
and
MEDICAL DIAGNOSTIC LABORATORIES L.L.C. 2439 KUSER ROAD HAMILTON, NJ 08690-3303TL: 609-570-1000 FX: 609-570-1050 TF: 877-269-0090
www.mdlab.com
11/5/2013Date Reported:11/5/2013Date Processed:
SSN:Patient Information: 5/16/1983 (Age:30)DOB:
DOE, JANE
CLINICAL INFORMATION5 PRINCETON MEADOWS ROAD
BROOKLYN, NY 11214
1301 - Liquid Pap TestTest Type:
1167176Patient ID:
Site of Collection: Cervical
LMP Date: 10/1/2013
1234567890NPI:Ordering Physician/Lab:
Date of Collection: 11/4/2013
JOHN DOE MD
Clinical History: Depo Provera
MOHYUDDIN ZAHRA, MD
Previous Results: Normal
202 ANY STREET
YOUNG AMERICA, NJ 55555
Tel: 555-555-5551
Fax: 609-570-1050 JANE DOE HOSPITALResults Faxed To:PATHOLOGY RESULTS
Physician CopyMDL#: 4891008 Test ResultsFinal
SATISFACTORY FOR EVALUATION.SPECIMEN ADEQUACY:
EPITHELIAL CELL ABNORMALITY.DIAGNOSTIC CATEGORY:
ATYPICAL SQUAMOUS CELLS OF UNDETERMINED SIGNIFICANCE FAVOR
HPV EFFECT.
INTERPRETATION /
DIAGNOSIS:
Previous Accession(s): 1. 13-G008403a 8/21/2013A: Epithelial Cell Abnormality..Atypical squamous cells, cannot exclude high-grade squamous
intraepithelial lesion (ASC-H).; Bacteria morphologically consistent with Actinomyces species .; Mild estrogen effect..
Case#: 13-G016261a
The Pap Test is a cytology-based cancer screening which is a highly effective test in
diagnosing cancer. However, because the Pap Test is inherently prone to sample-quality
variation, subjective interpretation error, and false-negative sampling, physicians should
utilize the test results in conjunction with other clinical best practices. This liquid-based
ThinPrep® pap test was screened with the assistance of the Hologic Duo image-guided
system. For more information please go to our website: www.mdlab.com/papsmear.
Hong-Guang Gao, M.D., FCAP
Pathologist
MOLECULAR RESULTSReference/Units/CommentsSpecimenDate Collected Source Normal Abnormal
105
Verified 11/5/2013
*
Thin-Prep - 1 VaginalPositive
Chlamydia trachomatis by Real-Time PCR (Reflex to
Azithromycin Resistance by Pyrosequencing)11/4/2013
A2058C mutation detected. Suggestive of
macrolide resistance.
111
Verified 11/5/2013
*
Thin-Prep - 1 VaginalNegative
Trichomonas vaginalis by Real-Time PCR (Reflex to
metronidazole resistance)11/4/2013
152
Verified 11/5/2013
*
Thin-Prep - 1 VaginalDetected
HPV Type-Detect 2.0 by Bio-Plex Analysis (Reflex to
HPV-16 Status by Real-Time PCR)11/4/2013
Subtypes HPV:16(HR). See explanation below.
Viral Status: Mixed, Viral Load: 2, Variant: EP.
See attached.
167
Verified 11/5/2013
*
Thin-Prep - 1 VaginalPositive
Neisseria gonorrhoeae by Real-Time PCR (Reflex to
Antibiotic Resistance by Bio-Plex Analysis)11/4/2013
Resistant to CFM, and PEN.
Sensitive to CIP, TET, AZM, and SPC.
*This test was developed and its performance characteristics determined by Medical Diagnostic Laboratories, L.L.C. It has not been cleared or approved by the U.S. Food and Drug Administration. The FDA
has determined that such clearance or approval is not necessary.
Thin-Prep-1;152:HPV Type-Detect 2.0 by Bio-Plex Analysis (Reflex to HPV-16 Status by Real-Time PCR);HPV-16 high-riskis the most common type among cervical cancer cases. It accounts for about half of all cases of squamous cell carcinoma worldwide. It is also the second most prevalent type in patients with cervical
adenocarcinomas. The presence of HPV-16 places a woman at 38 times the risk for the development of cervical cancer compared to those who are HPV negative. In accordance with ACOG
recommendations, women with a negative cytology screen who test positive for HPV-16 should have another cytology screen, and HPV test in 6 to 12 months. A vaccine that prevents persistent infection
with this virus is now commercially available. For additional information please refer to web site: www.mdlab.com.
Thin-Prep-1;167:Neisseria gonorrhoeae by Real-Time PCR (Reflex to Antibiotic Resistance by Bio-Plex Analysis)The specimen was tested for antibiotic resistance to Cefixime(CFM), Penicillin(PEN), Ciprofloxacin(CIP), Tetracycline(TET), Azithromycin(AZM), and Spectinomycin(SPC). Resistant isolates to injectable
Ceftriaxone have not yet been reported in the United States. For additional information regarding result interpretation please refer to web site www.mdlab.com.Detected mutations: G545S(penA),
Asp345A(penA)
Thin-Prep-1;105:Chlamydia trachomatis by Real-Time PCR (Reflex to Azithromycin Resistance by Pyrosequencing)The A2058C mutation within the 23S rRNA gene has been identified as one mechanism of macrolide resistance (Misyurina OY et al. Anti Microb Agents and Chemother. 2004). A negative result does not rule
out the possibility of resistance in all instances.
A positive result is provided for bacteria , virus, and/or fungal species when PCR amplification (real-time PCR), sequence information (Pyrosequencing), and/or signal detection (Bio- Plex Analysis) occurs
above cut-off levels established by the laboratory . Pertinent reference intervals for the tests reported above are available from the laboratory upon request.
NGONP/HPV16P
Overnight
YesAll
YesMail:
View:
Ver. 9.43Manual
NoAll
YesFax: 11/5/2013Final
MDL#: 4891008 13800Page 1 of 1 M M
MedicalDiagnosticLaboratories,L.L.C.www.mdlab.com•877.269.0090
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Actinomyces europaeusActinomyces israelii
Actinomyces turicensisAerobic Vaginitis (AV) Panel (GBS, S. aureus, E.coli, E. faecalis)
Atopobium vaginae Bacterial Vaginosis Panel [A. vaginae, BVAB2, G. vaginalis, Megasphaera species (Type 1 & 2)]
(with Lactobacillus Profiling)Bacterial Vaginosis Associated Bacterium 2 (BVAB2)
Bacteroides fragilisBacteroides ureolyticus
Candida albicansCandida albicans fluconazole resistance
Candida dubliniensisCandida glabrata
Candida glabrata fluconazole resistanceCandida kefyr
Candida kruseiCandida lusitaniae
Candida parapsilosisCandida parapsilosis fluconazole resistance
Candida tropicalisCandida tropicalis fluconazole resistance
Candida Vaginitis Panel (C. albicans, C. glabrata, C. parasilosis, C. tropicalis)Chlamydia trachomatis (**Reflex to Azithromycin Resistance)
Cytomegalovirus (CMV) (Reflex to Ganciclovir Resistance)Eggerthella species
Gardnerella vaginalis Genital Ulcer Disease Panel [H. ducreyi, HSV-1, HSV-2, T. pallidum (syphilis)]Group A Streptococcus
Group B Streptococcus (GBS)Group B Streptococcus (GBS) Antibiotic Resistance
Haemophilus ducreyiHerpes subtype (HSV-1, HSV-2)HPV Type-Detect 3.0® (Reflex to HPV-16 Risk Assessment Status) (Positive HPV-16 Only Req.)HPV Type-Detect 3.0® High Risk Subtypes Only (Reflex to HPV-16 Risk Assessment Status) (Positive HPV-16 Only Req.)HPV-16 and HPV-18 Klebsiella species (Reflex to Speciation)Leukorrhea Panel (N. gonorrhoeae*, C. trachomatis**, T. vaginalis♦)Lymphogranuloma venereum (LGV)Megasphaera species (Type 1 and Type 2)Mobiluncus mulieris and M. curtisiiMolluscum contagiosum virusMycoplasma genitalium (ψReflex to azithromycin & fluoroquinolone resistance)Mycoplasma hominisMycoplasma penetrans
Neisseria gonorrhoeae (*Reflex to antibiotic resistance)N. gonorrhoeae* & C. trachomatis**
Prevotella Species Group 1 (P. bivia, P. disiens, P. intermedia, P. melaninogenica)
Prevotella Species Group 2 (P. corporism, P. albensis)Proteus mirabilis
Pseudomonas aeruginosaSerratia marcescens
Staphylococcus aureusStaphylococcus aureus methicillin resistance (MRSA)
Panton-Valentine Leukocidin (PVL)Staphylococcus saprophyticus
Treponema pallidum (syphilis)Trichomonas vaginalis (♦Reflex to Metronidazole Resistance)
Ureaplasma parvum (§Reflex to fluoroquinolone resistance by Pyrosequencing)Ureaplasma urealyticum (§Reflex to fluoroquinolone resistance by Pyrosequencing)
Urogenital Mycoplasma Panel (M. genitaliumψ, M. hominis)Urogenital Mycoplasma & Ureaplasma Panel (M. genitaliumψ, M. hominis, U. urealyticum §)Varicella-Zoster Virus (VZV)
GENETIC CARRIER SCREENINGCystic Fibrosis Core Test (23 major CFTR mutations approved by ACOG/ACMG)
Cystic Fibrosis Comprehensive Test (191 variants of the CFTR gene, including the 23 major mutations approved by ACOG/ACMG)
Cystic Fibrosis Site Specific Analysis Sickle Cell Anemia by SNP Genotyping with Pyrosequencing
Torsion Dystonia by Real-Time PCR
Molecular Diagnostic Testing: ThinPrep®
Actinomyces israeliiAtopobium vaginae
Aerobic Vaginitis (AV) Panel (GBS, S. aureus, E.coli, E. faecalis)Bacterial Vaginosis (BV) Panel PCR [A. vaginae, BVAB2, G. vaginalis, Megasphaera species
(Types 1&2)] (with Lactobacillus Profiling)Bacterial Vaginosis Associated Bacterium 2 (BVAB2)
Bacteroides fragilisCandida albicans
Candida glabrataCandida parapsilosis
Candida tropicalisCandida Vaginitis Panel (C. albicans, C. glabrata, C. parapsilosis, C. tropicalis)
Chlamydia trachomatis (**Reflex to Azithromycin Resistance)Cytomegalovirus (CMV) (Reflex to Ganciclovir Resistance)
Eggerthella speciesEnterococcus faecalis
Escherichia coli Gardnerella vaginalis
Genital Ulcer Disease Panel [H. ducreyi, HSV-1, HSV-2, T. pallidum (syphilis)]Group B Streptococcus (GBS)
Haemophilus ducreyiHerpes subtype (HSV-1, HSV-2)
HPV Type-Detect 3.0® (Reflex to HPV-16 Risk Assessment Status) (Positive HPV-16 Only Req.)
HPV Type-Detect 3.0® High Risk Subtypes Only (Reflex to HPV-16 Risk Assessment Status)
(Positive HPV-16 Only Req.)HPV-16 & HPV-18
Leukorrhea Panel (N. gonorrhoeae*, C. trachomatis**, T. vaginalis♦)Lymphogranuloma venereum (LGV)
Megasphaera species (Type 1 and Type 2)Mobiluncus mulieris and M. curtisii
Molluscum contagiosum virus (MCV)Mycoplasma genitalium (ψReflex to azithromycin & fluoroquinolone resistance)
Mycoplasma hominisNeisseria gonorrhoeae (*Reflex to Antibiotic Resistance)
N. gonorrhoeae* & C. trachomatis**Staphylococcus aureus
Treponema pallidum (syphilis)Trichomonas vaginalis (♦Reflex to Metronidazole Resistance)
Ureaplasma urealyticum (§Reflex to fluoroquinolone resistance by Pyrosequencing)Urogenital Mycoplasma & Ureaplasma Panel (M. genitaliumψ, M. hominis, U. urealyticum§)
GENETIC CARRIER SCREENINGCystic Fibrosis Core Test (23 major CFTR mutations approved by ACOG/ACMG)
Cystic Fibrosis Comprehensive Test (191 variants of the CFTR gene, including the 23 major mutations approved by ACOG/ACMG) Cystic Fibrosis Site Specific Analysis
ThinPrep®
OneSwab®Available off the
Available off the