Medical Diagnostic Laboratories, L.L.C.2439 Kuser Road • Hamilton, NJ 08690-3303www.mdlab.com • Toll Free 877 269 0090

One Vial... Multiple Pathogens

OneSwab ®

Simple & Convenient Multipurpose Specimen Collection

150 Actinomyces europaeus143 Actinomyces israelii

149 Actinomyces turicensis182 Aerobic Vaginitis (AV) Panel (GBS, S. aureus, E.coli, E. faecalis)

142 Atopobium vaginae 166 Bacterial Vaginosis Panel [A. vaginae, BVAB2, G. vaginalis,

Megasphaera species (Type 1 & 2)] (with Lactobacillus Profiling by qPCR)

164 Bacterial Vaginosis Associated Bacteria 2 (BVAB2)125 Bacteroides fragilis

147 Bacteroides ureolyticus551 Candida albicans

581 Candida albicans fluconazole resistance576 Candida dubliniensis

559 Candida glabrata582 Candida glabrata fluconazole resistance578 Candida kefyr

566 Candida krusei577 Candida lusitaniae558 Candida parapsilosis583 Candida parapsilosis fluconazole resistance557 Candida tropicalis584 Candida tropicalis fluconazole resistance560 Candida Vaginitis Panel (C. albicans, C. glabrata, C. parasilosis, C. tropicalis)105 Chlamydia trachomatis (**Reflex to Azithromycin Resistance by Pyrosequencing)207 Cytomegalovirus (CMV) (Reflex to Ganciclovir Resistance by Pyrosequencing)175 Eggerthella species 153 Enterococcus faecalis141 Escherichia coli 132 Gardnerella vaginalis 115 Genital Ulcer Disease Panel [H. ducreyi, HSV-1, HSV-2,T. pallidum (syphilis)]1112 Group A Streptococcus127 Group B Streptococcus (GBS)137 Group B Streptococcus (GBS) Antibiotic Resistance122 Haemophilus ducreyi126 Herpes subtype (HSV-1, HSV-2)

152 Human Papillomavirus (HPV) Type-Detect® 2.0 (Reflex to HPV-16 Risk Assessment Status)

190 HPV-16 and HPV-18 by Multiplex Real-Time PCR172 Klebsiella species (Reflex to Speciation by Pyrosequencing)

121 Leukorrhea Panel (N. gonorrhoeae*, C. trachomatis**, T. vaginalis*)136 Lymphogranuloma venereum (LGV)

165 Megasphaera species (Type 1 and Type 2)124 Mobiluncus mulieris and M. curtisii

128 Molluscum contagiosum virus129 Mycoplasma genitalium

130 Mycoplasma hominis335 Mycoplasma penetrans

167 Neisseria gonorrhoeae (*Reflex to antibiotic resistance)109 N. gonorrhoeae* & C. trachomatis**

362 Prevotella Species Group 1 (P. bivia, P. disiens, P. intermedia, P. melaninogenica)363 Prevotella Species Group 2 (P. corporism, P. albensis)

146 Proteus mirabilis174 Pseudomonas aeruginosa

177 Serratia marcescens184 Staphylococcus aureus

1118 Staphylococcus aureus methicillin resistance (MRSA)1119 Panton-Valentine Leukocidin (PVL)

151 Staphylococcus saprophyticus110 Treponema pallidum (syphilis)

111 Trichomonas vaginalis (*Reflex to Metronidazole Resistance) 178 Ureaplasma parvum

320 Ureaplasma urealyticum131 Urogenital Mycoplasma Panel (M. genitalium, M. hominis)

134 Urogenital Mycoplasma & Ureaplasma Panel (M. genitalium, M. hominis, U. urealyticum)215 Varicella-zoster Virus (VZV)

GENETIC CARRIER SCREENING1213 Ashkenazi Jewish Carrier Screening Panel (Canavan disease, Cystic Fibrosis, Familial Dysautonomia, Tay Sach’s disease)1214 Ashkenazi Jewish Carrier Screening Expanded Panel (Bloom Syndrome, Canavan disease, Cystic Fibrosis, Familial Dysautonomia, Fanconi Anemia Type C, Gaucher disease, Mucolipidosis Type IV, Niemann-Pick disease Type A, Tay Sach’s disease)1207 Bloom Syndrome1209 Canavan Disease1201 Cystic Fibrosis Gene Carrier Screening1220 Factor V Leiden and Factor II Prothrombin1217 Factor XI Deficiency1210 Familial Dysautonomia1205 Fanconi Anemia Type C1211 Gaucher Disease1203 Huntington’s Disease1218 Kennedy’s Disease1212 Mucolipidosis Type IV1206 Niemann-Pick Disease Type A1216 Sickle Cell Anemia by SNP Genotyping1208 Tay-Sachs Disease1215 Torsion Dystonia

The introduction of molecular techniques, such as the Polymerase Chain Reaction (PCR) method, offers a superior route of pathogen detection with a high diagnostic specificity and sensitivity. MDL offers a number of assays for the detection of multiple pathogens associated with sexually transmitted diseases and gynecologic infections. The unrivaled sensitivity and specificity of the Real-Time PCR method in detecting infectious agents provides the clinician with an accurate and rapid means of diagnosis, with a turnaround time of 24-48 hours. This valuable diagnostic tool will assist the clinician with diagnosis, early detection, patient stratification, drug prescription, and prognosis. Tests currently available utilizing the OneSwab ® specimen collection platform are listed to the side.

MULTIPLE PATHOGENSOneSwab

®

• One vial, multiple pathogens• DNA amplification via PCR technology• Microbial drug resistance profiling• High precision robotic accuracy• High diagnostic sensitivity & specificity• 24 - 48 hour turnaround time• Specimen viability up to 5 days• Test additions available up to 30 days• No refrigeration required before or after collection• Blood and excess mucus will not affect results

Available Exclusively at MDLBacterial Vaginosis (BV) Panel with

Lactobacillus ProfilingMeasure the relative concentration of Lactobacillus species

detected in relation to BV-associated microorganisms

Receive a graphical representation of relative vaginal microflora composition on the result report…

Bacterial Vaginosis Panel by Real-Time PCR• Atopobium vaginae • BVAB2 (Bacterial Vaginosis Associated Bacteria 2)• Gardnerella vaginalis• Megasphaera species Type 1 • Megasphaera species Type 2

o Ability to monitor response to antibiotic therapy

Before Therapy After 1 week course of metronidazole

MEDICAL DIAGNOSTIC LABORATORIES L.L.C.2439 KUSER ROAD

HAMILTON, NJ 08690-3303

TL: 609-570-1000 FX: 609-570-1050 TF: 877-269-0090

www.mdlab.com

Date Reported:Date Processed:Patient ID:

NPI:

Physician Copy

Ordering Physician/Lab:DOB:SSN:Patient Information:

MDL#: Test ResultsFinal

4005618

XXX-XX-3333 1/2/1970

DOES, JANE

45 LIBERTY DRIVE

DAYTON, NJ 08810

Home: (555) 555-5555

1234567890

JOHN DOE MD

JOHN DOE, MD202 ANY STREET

BROOKLYN, MN 11214

Tel: 555-555-5551

Fax: 555-555-5555

1222112 2/14/2012 2/16/2012

Results faxed to:JANE DOE HOSPITAL

Reference/Units/CommentsAbnormalResults

Normal

Date Collected

CommentSpecimenTest

Gardnerella vaginalis by Real-Time PCR 2/13/2012 Positive

132 Verified 2/15/2012 Swab - 2

Vaginal*

Atopobium vaginae by Real-Time PCR 2/13/2012 Positive

142 Verified 2/16/2012 Swab - 2

Vaginal*

Bacterial Vaginosis Associated Bacteria 2

(BVAB2) by Real-Time PCR

2/13/2012 Positive

164 Verified 2/16/2012 Swab - 2

Vaginal*

Megasphaera species (Type 1 and Type 2) by

Real-Time PCR

2/13/2012 Positive

165 Verified 2/15/2012 Swab - 2

Type1

Vaginal*

Indicative of Abnormal microflora.

Suggestive of Bacterial Vaginosis.

All

USPS

Yes All NoFinal

4/18/2012

MDL#: 4005618

Fax: ManualMail:

View:

Yes YesVer. 5.18

Page 1 of 5 M

MEDICAL DIAGNOSTIC LABORATORIES L.L.C.2439 KUSER ROAD

HAMILTON, NJ 08690-3303

TL: 609-570-1000 FX: 609-570-1050 TF: 877-269-0090

www.mdlab.com

Date Reported:Date Processed:Patient ID:

NPI:

Physician Copy

Ordering Physician/Lab:DOB:SSN:Patient Information:

MDL#: Test ResultsFinal

4011220

XXX-XX-3333 1/2/1970

DOES, JANE

45 LIBERTY DRIVE

DAYTON, NJ 08810

Home: (555) 555-5555

1234567890

JOHN DOE MD

JOHN DOE, MD202 ANY STREET

BROOKLYN, MN 11214

Tel: 555-555-5551

Fax: 555-555-5555

1222112 3/30/2012 3/31/2012

Reference/Units/CommentsAbnormalResults

Normal

Date Collected

CommentSpecimenTest

Gardnerella vaginalis by Real-Time PCR 3/29/2012 Negative

132 Verified 3/30/2012 Swab - 1

Not Indicated*

Atopobium vaginae by Real-Time PCR 3/29/2012 Negative

142 Verified 3/30/2012 Swab - 1

Not Indicated*

Bacterial Vaginosis Associated Bacteria 2

(BVAB2) by Real-Time PCR

3/29/2012 Negative

164 Verified 3/31/2012 Swab - 1

Not Indicated*

Megasphaera species (Type 1 and Type 2) by

Real-Time PCR

3/29/2012 Negative

165 Verified 3/31/2012 Swab - 1

Not Indicated*

Indicative of Normal microflora.

Negative for Bacterial Vaginosis.

All

USPS

Yes All NoFinal

4/18/2012

MDL#: 4011220

Fax: ManualMail:

View:

Yes YesVer. 5.18

Page 1 of 5 M

1213 Ashkenazi Jewish Carrier Screening Panel (Canavan disease, Cystic Fibrosis, Familial Dysautonomia, Tay Sach’s disease)

1214 Ashkenazi Jewish Carrier Screening Expanded Panel (Bloom Syndrome, Canavan disease, Cystic Fibrosis, Familial Dysautonomia, Fanconi Anemia Type C, Gaucher disease, Mucolipidosis Type IV, Niemann-Pick disease Type A,

Tay Sach’s disease)1207 Bloom Syndrome1209 Canavan Disease1201 Cystic Fibrosis Gene Carrier Screening1220 Factor V Leiden and Factor II Prothrombin1217 Factor XI Deficiency1210 Familial Dysautonomia1205 Fanconi Anemia Type C1211 Gaucher Disease1203 Huntington’s Disease1218 Kennedy’s Disease1212 Mucolipidosis Type IV1206 Niemann-Pick Disease Type A1216 Sickle Cell Anemia by SNP Genotyping1208 Tay-Sachs Disease1215 Torsion Dystonia

MDL is pleased to announce the availability of genetic carrier testing on the OneSwab®

platform. OneSwab® technology provides a minimally invasive collection method that provides sufficient sample quantities obtained from a cervicovaginal or buccal swab with a rapid turnaround time of only 24 – 48 hours. Testing is now available for nine commonly inherited disorders included in the 2004 American College of Obstetricians and Gynecologists (ACOG) recommendations for all couples of Ashkenazi Jewish ancestry.

• Cervicovaginal or buccal swab• No refrigeration required before or after collection• Rapid turnaround time of only 24-48 hours• Test additions available for up to 30 days• Specimen viability up to five (5) days

Tests currently available on the OneSwab®

Genetic Carrier Screening

An Even Better Choice…HPV Type-Detect® 2.0 by Bio-Plex Analysis

Simple & Convenient Specimen Collection

• Differentiates between 14 HR and 5 LR HPVs

• Determines patient’s specific HPV type(s)

Liquid DNA bead-based technology

• Detects newly acquired HPV infections

• Detects multiple infections

• No cross-reaction with other HPV types

• Not affected by blood & excess mucus

• Detects as few as 100 copies per reaction

Medical Diagnostic Laboratories, L.L.C.www.mdlab.com

877.269.0090

The only testthat offers type specific detection of

High-risk

Low-risk

High-risk/High prevalency

19 HPV subtypes in a single vial

HPV-16 Risk Assessment

at no additional cost!

Candida Vaginitis (CV)• Candidaalbicans• Candidaglabrata• Candidaparapsilosis• Candidatropicalis

Diagnostic Advantages…• One vial, multiple pathogens• DNA amplification via PCR technology• Microbial drug resistance profiling for Candida• High precision robotic accuracy• High diagnostic sensitivity & specificity• 24 - 48 hour turnaround time• Specimen viability up to 5 days• Test additions available up to 30 days• No refrigeration required before or after collection• Blood and excess mucus will not affect results

The ABC’s of Vaginal Health…

Aerobic Vaginitis (AV)• Group B Streptococcus (GBS)• Staphylococcusaureus• Escherichiacoli• Enterococcusfaecalis

Bacterial Vaginosis (BV)• Atopobiumvaginae• Bacterial Vaginosis Associated Bacteria 2 (BVAB2)• Gardnerellavaginalis• Megasphaeraspecies (Type 1 and Type 2)• Lactobacillus Profiling by qPCR

Comparison of Multiple Assay Systems for the Detection of Gynecological Pathogens

=Unless otherwise noted, all specimens are swabs.a

=Calculated data.b

Herpes simplex virus (HSV)

PCR194 59 100 100 100 100 (3)104 53 100 100 100 100 (4)

Culture 194 48 81 100 100 85.1 (3)104 41 78 98 96.4 86.5 (4)

EIA 194 39 65 98.7 96.9 81.5 (3)104 27 56 93 74.8 85.1 (4)

Test N Prevalence (%)

Sensitivity (%)

Specificity (%)

PPV (%)

NPV (%) Referencesa

Neisseria gonorrhoeae

PCR 100 7.8 100 99.4 93.4 100 (9)Amplicor 2238 5.2 96.3 98.7 80.2 99.8 (10)AptimaCombo 2

1479 8.6 99.2 98.7 88.1 99.9 (13)

BD ProbeTec 1411 8.1 97.2 99.4 91.6 99.6 (14)GEN-PROBE (Pace 2) 1750 8.7 97.1 99.1 90.6 99.8 (11)

Culture 866 4.5 50.0 97.1 40.0 98.0 (12)

Test N Prevalence (%)

Sensitivity (%)

Specificity (%)

PPV (%)

NPV (%) Referencesa

Chlamydia trachomatis

Test N Prevalence (%)

Sensitivity (%)

Specificity (%)

PPV (%)

NPV (%) Referencesa

PCR 1000 12.9 98 100 100 100 (6)Amplicor 2254 7.5 96.9 98.6 84.9 99.7 (7)Aptima Combo 2 1389 15.0 94.2 97.6 87.4 99.0 (13)

BD ProbeTec 1419 9.9 98.7 97.8 84.8 99.1 (14)GEN-PROBE (Pace 2) 940 3.9 75.5 97.0 50.5 99.0 (8)

b b b

b b b

References:12. Skulnick M, Chua R, Simor AE, et al. (1994). Diagn. Microbiol.

Infect. Dis. 20:195-201.13. Crotchfelt KA, Welsh LE, DeBonville D, et al. (1997). J. Clin

Microbiol. 35:1536-1540.14. 510(k) Summary, http://www.fda.gov/cdrh/pdf/k974503.pdf.

15. Vlaspolder F, Mutsaers JA, Blog F, et al. (1993). J. Clin. Microbiol.31:107-110.

16. Donders GG, Van Gerven V, de Wet HG, et al. (1996). Scand. J. Infect. Dis. 28:559-562.

17. Gaydos CA, Quinn TC, Willis D, et al. (2003). J. Clin. Microbiol.41:304-309.

18. Van Der Pol B, Ferrero DV, Buck-Barington L, et al. (2001). J. Clin. Microbiol. 39:1008-1016.

1. Hong IS, Marshalleck J, Williams RH, et al. (2002). Acta Cytol. 46: 828-34.2. Lie AK, Skjeldestad FE, Hagen B. et al. (1997). APMIS. 105:115-120.3. Slomka MJ, Emery L, Munday PE, et al. (1998). J. Med. Virol. 55:177-183.4. Burrows J, Nitsch A, Bayly B, et al. (2002). BMC Microbiol. 2:12.5. Mayta H, Gilman RH, Calderon MM, et al. (2000). J. Clin. Microbiol. 38:

2683-2687.6. Patel SR, Wiese W, Patel SC, et al. Infect Dis Obstet Gynecol. (2000)7.

Transm Infect. 74:136-139.8. Jalal H, Al-Suwaine A, Stephen H, et al. (2007). J Med Microbiol. 56:320-22.9. 510(k) Summary, http://www.fda.gov/cdrh/pdf/k973707.pdf. Accessed

06/2007.10. Blanding J. Hirsch L, Stranton N, et al. (1993). J. Clin. Microbiol. 31:1622-

1625.11. Clarke LM, Sierra MF, Daidone BJ, et al. (1993). J. Clin. Microbiol. 31:968-

971.

Paterson BA, Tabrizi SN, Garland SM, et al. (1998). Sex8:248-257.

Accessed 06/2007.

Trichomonas vaginalis

PCR372

8.3 100 99.7 81.9 100(5)

Culture 6.5 83.3 98.0 74.3 98.8PCR

9,9828.3 95.0 98.0 81.1 99.5

(6)ELISA 6.5 82.0 73.0 17.5 98.3PCR

59015.8 100 ND ND ND

(7)Pap smear 8.6 59.4 ND ND ND

Test N Prevalence (%)

Sensitivity (%)

Specificity (%)

PPV (%)

NPV (%) References

Human Papillomavirus (HPV)

PCR

Total (n = 596) 37.8

100 100 100 100

Normal Cytology 25.1ASCUS 55.9

Low Grade SIL 68.7High Grade SIL 81.6

Squamous cervical carcinomas 100

HC-II

Total (n = 596) 32.9 78.7 89.2 78.12 89.52

Normal Cytology19.5

(14.3 HR) 70.0 80.8 46.90 91.75

ASCUS 52.9 (41.1)

87.3 97.5

97.51 87.24Low Grade SIL 64.5 (59.4) 98.45 80.86High Grade SIL 81.6 99.36 63.39

Sqaumous cervical carcinoma 100 100 -

Test Specimen Prevalence (%)

Sensitivity (%)

Specificity (%)

PPV (%)

NPV (%) References

(1, 2)

(1, 2)

1. HongIS,MarshalleckJ,WilliamsRH,et al.(2002).Acta Cytol.46:828-34.

2. LieAK,SkjeldestadFE,HagenB.et al.(1997).APMIS.105:115-120.3. SlomkaMJ,EmeryL,MundayPE,et al.(1998).J Med Virol.55:177-183.4. BurrowsJ,NitschA,BaylyB,et al.(2002).BMC Microbiol.2:12.5. PatersonBA,TabriziSN,GarlandSM,et al.(1998).Sex Transm Infect.

74:136-139.6. PasternackR,VuorinenP,PitkajarviT,et al.(1997)J Clin Microbiol.35:

402-405.7. 510(k)Summary,http://www.fda.gov/cdrh/pdf/k973707.pdfAccessed

06/2007.8. BlandingJ.HirschL,StrantonN,et al.(1993).J Clin Microbiol.31:1622-

1625.9. CrotchfeltKA,WelshLE,DeBonvilleD,et al.(1997).J Clin Microbiol.

35:1536-1540.

References:10. 510(k)Summary,http://www.fda.gov/cdrh/pdf/k974503.pdf.Accessed

06/2007.11. VlaspolderF,MutsaersJA,BlogF,et al.(1993).J Clin Microbiol.

31:107-110.12. DondersGG,VanGervenV,deWetHG,et al.(1996).Scand J Infect

Dis.28:559-562.13. GaydosCA,QuinnTC,WillisD,et al.(2003).J Clin Microbiol.41:304-

309.14. VanDerPolB,FerreroDV,Buck-BaringtonL,et al.(2001).J Clin Micro-

biol.39:1008-10115. AndreaSB,ChapinKC.(2011).J Clin Microbiol 49:866-9.

Test N Prevalence(%)

Sensitivity(%)

Specificity(%)

PPV(%)

NPV(%) References

PCR590

15.8 ND ND ND ND(5)

Pap smear 8.6 59.4 ND ND NDAffirm 766 3.4 63.4 99.9 96.3 98.0 (15)

Founded in 1998, Medical Diagnostic Laboratories, L.L.C. (MDL) serves mainly as a reference laboratory for molecular diagnostic based testing to laboratories, hospitals and physicians worldwide. The success of MDL is attributed directly to client retention through our ability to customize our unique services to specifically address the individual needs of our clients. Enhanced turn-around time, cost effectiveness, and the capability to tailor services to best suit the needs and budgets of our clients gives MDL a distinct advantage over its competitors.

MDL specializes in high complexity, state-of-the-art, automated DNA-based molecular analysis. By utilizing molecular techniques, MDL is able to provide clinicians from many different specialties valuable diagnostic information to assist in the detection, diagnosis, evaluation, and treatment of bacterial, viral and fungal infections as well as genetic based testing and cancer diagnostics. For example, the unique testing MDL offers for the specialties of Urology, Gynecology and Pediatric Medicine enables the detection of multiple pathogens from a single swab by Polymerase Chain Reaction (PCR) testing. MDL’s primary focus is in the fields of infectious disease testing for Women’s Health and Gynecology, Pediatric Respiratory Infections, Urology, Vector-borne Diseases, Mycology and chronic illnesses.

Laboratory Licenses and PermitsMDL is recognized for its continued excellence in participation of the proficiency testing programs administered by both the College of American Pathologists (CAP) as well as the New York State Department of Health. MDL is licensed in multiple states, including New York, Florida, and California. As a result, MDL is regularly inspected by the New York Department of Health, New Jersey Department of Health and the federal CLIA program and must adhere to strict regulations and quality control guidelines. MDL has continually maintained exemplary ratings by these agencies.

The testing offered by Medical Diagnostic Laboratories, L.L.C. is developed and validated by MDL’s Research & Development Department. The R&D Department performs studies on sensitivity, specificity, interference, optimization, accuracy, and precision prior to offering testing for a specific pathogen by PCR. These studies are used to establish the ability of the PCR method to detect specific genetic sequences of a target pathogen within a given clinical specimen.

New Jersey - Clinical Laboratory License - ID #0000875Florida - Clinical Laboratory License - ID #800014396New York - Clinical Laboratory Permit - PFI #7469Maryland - Medical Laboratory Permit - ID #1133

Pennsylvania - Clinical Laboratory Permit - ID #026538Rhode Island - Clinical Laboratory License - ID #LCO00420California - Clinical Laboratory License - ID #COS800136CLIA - ID #31D0938156

Medical Diagnostic Laboratories, L.L.C.

The proper specimen collection technique is very important in identifying pathogens from DNA. Medical Diagnostic Laboratories, L.L.C. provides the OneSwab®, and UroSwab® specimen collection platforms for your convenience. For women, the sequence of Pap testing in relation to other cervical or vaginal specimens does not appear to influence Pap test results or their interpretation. Therefore, when other specimens are collected for gynecological testing, the Pap test can be obtained last.

Collecting samples with OneSwab®

Step 1. Firmly, yet gently, sample the endocervical canal with the sterile swab rotating it 360° for 10 to 30 seconds to ensure adequate sampling. When sampling a crusted over lesion, moisten the swab in sterile saline prior to taking the sample.

Step 2. Remove the swab and place into the vial. Break the shaft at scored break point and insert into transport medium.

Step 3. To prevent leakage, be sure the swab fits into the vial prior to capping. Tightly cap the vial and label with a minimum of two patient identifiers such as name and date of birth. For packaging and shipping instructions, please refer to MDL’s catalog of services.

Collecting samples for Vaginal Group B Strep (GBS) with OneSwab®

Obtaining specimens for the diagnosis of GBS infection from both the anorectum and the distal vagina increases the sensitivity by a considerable percentage (5% to 25%) over vaginal swabbing alone. Within the genital tract, the highest isolation rates are reported from introitus and the lowest from the cervix.Pregnancy does not influence colonization.

PCR Testing For Best Results

Collecting samples of loose stool specimens with OneSwab®

Step 1. Utilize the swab provided to obtain a sample of loose stool and insert into the vial.Step 2. Break the shaft at scored break point and insert into transport medium. Step 3. To prevent leakage, be sure the swab fits into the vial prior to capping. Tightly cap the

vial and label with a minimum of two patient identifiers such as name and date of birth. For packaging and shipping instructions, please refer to MDL’s catalog of services.

Collecting samples with UroSwab®

Step 1. Urine collection should be at least one hour between voids.Step 2. Have the patient collect a urine sample in a urine container. Step 3. Dip the sponge into the urine container. Step 4. Place the sponge into the vial. To prevent leakage, tightly cap the vial. Label with a

minimum of two patient identifiers such as name and date of birth. For packaging and shipping instructions, please refer to MDL’s catalog of services.

An Even Better Choice…HPV Type-Detect® 2.0 by Bio-Plex Analysis

Simple & Convenient Specimen Collection

• Differentiates between 14 HR and 5 LR HPVs

• Determines patient’s specific HPV type(s)

Liquid DNA bead-based technology

• Detects newly acquired HPV infections

• Detects multiple infections

• No cross-reaction with other HPV types

• Not affected by blood & excess mucus

• Detects as few as 100 copies per reaction

Medical Diagnostic Laboratories, L.L.C.www.mdlab.com

877.269.0090

The only testthat offers type specific detection of

High-risk

Low-risk

High-risk/High prev. 19 HPV subtypes in a single vial

Simple 1-2-3-4 Process

Collect RecapDip Package

Urinary tract infections are a major cause of morbidity in the United States. They are the second most common infection after respiratory infections, and largely affect women. Approximately 11% of women suffer from a UTI, 60% of women will have at least one UTI during their lifetime, 25% of UTIs will recur within six months of the initial infection. Although UTIs are not sexually transmitted, they frequently occur in young, sexually active women, although they are by no means confined to this population. Medical Diagnostic Laboratories, L.L.C., (MDL) has developed sensitive and specific Real-Time PCR tests to detect these pathogens in UroSwab® specimens from female patients to assist the physician in the diagnosis of UTI. Benefits of this system include:

• Real-Time PCR• Simple, Convenient & Non-invasive sample collection• No refrigeration required before or after collection• Specimen viability up to five (5) days• Test additions available up to 30 days• 24-48 hour turnaround time, and 72 hours for antibiotic reflex testing

Available on the UroSwab®...

Urinary Tract Infections

• amoxicillin-clavulanic acid• cephalothin (cephalexin) • trimethoprim-sulfamethoxazole• nitrofurantoin• ciprofloxacin • fosfomycin

• ampicillin• nitrofurantoin • ciprofloxacin• fosfomycin• doxycycline• linezolid

E. coli, Klebsiella species, Proteus mirabilis:

Enterococcus faecalis,Enterococcus faecium

153 Enterococcus faecalis 154 Enterococcus faecium 141 Escherichia coli127 GroupBStreptococcus(GBS)137 GroupBStreptococcus(GBS)AntibioticResistance172 Klebsiella species(ReflextoSpeciationbyPyrosequencing)146 Proteus mirabilis 174 Pseudomonas aeruginosa151 Staphylococcus saprophyticus176 UrinaryPathogensAntibioticResistanceTesting(E. coli, Enterococcus faecalis, Enterococcus faecium, Klebsiellaspecies,Proteus mirabilis)

Urinary Pathogens Antibiotic Resistance

Tests available by Real-Time PCR:

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The introduction of molecular techniques, such as the Polymerase Chain Reaction (PCR) method, offers a superior route of pathogen detection with a high diagnostic specificity and sensitivity. MDL offers a number of assays for the detection of multiple pathogens associated with urological infections and sexually transmitted infections. The unrivaled sensitivity and specificity of the Real-Time PCR method in detecting infectious agents provides the clinician with an accurate and rapid means of diagnosis, with a turnaround time of 24-48 hours. This valuable diagnostic tool will assist the clinician with diagnosis, early detection, patient stratification, drug prescription, and prognosis. Tests currently available utilizing the UroSwab ® specimen collection platform are listed to the side.

UroSwab ®

MULTIPLE PATHOGENS

• One vial, multiple pathogens• DNA amplification via PCR technology• Simple & Convenient Specimen Collection• High precision robotic accuracy• High diagnostic sensitivity & specificity• 24 - 48 hour turnaround time• Specimen viability up to 5 days• Test additions available up to 30 days• No refrigeration required before or after collection

369 Acinetobacter baumannii 150 Actinomyces europaeus

149 Actinomyces turicensis 222 Adenovirus

147 Bacteroides ureolyticus 551 Candida albicans

576 Candida dubliniensis 559 Candida glabrata

578 Candida kefyr 566 Candida krusei

577 Candida lusitaniae 558 Candida parapsilosis

557 Candida tropicalis 574 Candida utilis 554 Cryptococcus neoformans 207 Cytomegalovirus (CMV) (Reflex to Ganciclovir Resistance by Pyrosequencing)205 Epstein-Barr virus (EBV) 152 Human Papillomavirus (HPV) Type-Detect® 2.0 by BioPlex Analysis190 HPV-16 and HPV-18 by Multiplex Real-Time PCR 318 Legionella pneumophila 136 Lymphogranuloma venereum (LGV) 129 Mycoplasma genitalium 130 Mycoplasma hominis 335 Mycoplasma penetrans 362 Prevotella Species Group 1 (P. bivia, P. disiens, P. intermedia, P. melaninogenica) 363 Prevotella Species Group 2 (P. corporism, P. albensis) 138 Polyomavirus BK 139 Polyomavirus JC 111 Trichomonas vaginalis (*Reflex to Metronidazole Resistance) 178 Ureaplasma parvum320 Ureaplasma urealyticum

575 Urogenital Candidiasis Panel (C. albicans, C. glabrata, C. parapsilosis, C. tropicalis)131 Urogenital Mycoplasma Panel (M. genitalium, M. hominis)

134 Urogenital Mycoplasma & Ureaplasma Panel (M. genitalium, M. hominis, U. urealyticum)

215 Varicella-zoster Virus (VZV)

URINARY TRACT INFECTIONS (male and female specimens)153 Enterococcus faecalis

154 Enterococcus faecium 141 Escherichia coli

127 Group B Streptococcus (GBS)137 Group B Streptococcus (GBS) Antibiotic Resistance

172 Klebsiella species (Reflex to Speciation by Pyrosequencing)146 Proteus mirabilis

174 Pseudomonas aeruginosa151 Staphylococcus saprophyticus 176 Urinary Pathogens Antibiotic Resistance Testing (E. coli, Enterococcus faecalis, Enterococcus faecium,

Klebsiella species, Proteus mirabilis)

SEXUALLY TRANSMITTED DISEASE TESTING (male and female specimens)105 Chlamydia trachomatis (**Reflex to Azithromycin Resistance by Pyrosequencing) ‡

121 Leukorrhea Panel (N. gonorrhoeae*, C. trachomatis**, T. vaginalis*)‡167 Neisseria gonorrhoeae (*Reflex to antibiotic resistance) ‡109 N. gonorrhoeae* & C. trachomatis**‡111 Trichomonas vaginalis (*Reflex to Metronidazole Resistance) ‡

‡ Applicable for adolescent females who are not candidates for pelvic exams.

MALE SPECIMENS ONLY:

One Vial... Multiple Pathogens

UroSwab ®

Simple & Convenient Urine Specimen Collection

Medical Diagnostic Laboratories, L.L.C.2439 Kuser Road • Hamilton, NJ 08690-3303www.mdlab.com • Toll Free 877 269 0090