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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

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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