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USAFSAMEpidemiology
Laboratory Service
Distribution Statement A: Approved for Public release; distribution is unlimited. 311 ABG/PA No. 10-084, 12 Mar 2010
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Microbiology• Virology• Bacteriology• Parasitology
Immunodiagnostics• HIV, Hepatitis• Infectious Disease Serology
Molecular DiagnosticsLIS
• CST (Customer Service Team)• LIS (Lab Information Systems)• COPS (Central Operations)
Programs• Influenza Surveillance• USAF HIV Testing/Repository• USAF Recruit Health Testing• Clinical Infections Disease Testing
• LRN Reference Lab
DoD’s only Clinical Reference Laboratory
220+ DoD Customers
2.0+ Million Tests per Year
USAFSAM “EPI Lab”
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Laboratory Information Systems
Customer Service Team (CST)
Lab Information Systems (LIS)
Central Operations (COPS)
Personnel = 3 CST, 3 LIS, 20 COPS
Handle customer/specimen problems
Customer newsletters
Customer satisfaction surveys
Generate customer feedback reports
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Central Operations
Boxes arrive in lab Boxes opened, specimens sorted
Information verifiedAccessioned into CHCSSpecimens delivered to sections
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Receive ~ 5000 specimens/ 8 hr day (~2.0 million/year)
Could easily ramp up to ~ 3x that volume by adding shifts
Boxes usually arrive at ~ 0800
Delivered to testing sections in batches every half hour
Central Operations
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EpiLab Web site
https://kx.afms.mil/epi/
Shipping Instructions
Shipping Material Ordering Information
Lab Guide
Import certificate
CLIP and CAP certificates
List of tests
Training videos
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EpiLab Web site
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BIOPLEX 2200
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Immunodiagnostics
Tests Performed:
ANA – Positive Screen Reflexes to SSA, SSB, Sm, RNP, dsDNA, and Centromere
Syphilis – Reactives Sent to IFA Section for Confirmation by VDRL and FTA-ABS
EBV IgG, IgM, EBNA IgG - No Reflex or Confirmation Testing Performed
NEW: HSV-1 & HSV-2 IgG (Moved to Bioplex on 22 Dec 2009)
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EIAHelicobacter pylori IgG –Discontinue serum test replacing with stool test 1April 10
Cytomegalovirus (CMV) IgG, IgM
Lyme Disease (Borrelia burgdorferi)
Mumps IgG
Measles (Rubeola) IgG
Varicella IgG DSX instrumentManual tests include:
Cardiolipin IgG, IgM – Discontinued test 1 Oct 09
Coccidioides Immunodiffusion Test
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IFA & MANUAL
Autoantibody Profile (AMA, ASMA, APCA)
Mycoplasma pneumoniae IgM
Cytomegalovirus (CMV) IgM
Lyme Disease (Borrelia burgdorferi) IgG, IgM Western Blot
Rickettsia IgM
Q Fever (Coxiella burnetti) IgG, IgM
VDRL Slide Test
FTA-ABS Double Stain (performed on non-reactive VDRL’s)
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HIV
Tests Performed:
HIV 1/2/O
HIV Type 1 Western Blot (manual)
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Siemens Centaur XP
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Total HIV ScreensJAN 35999FEB 31858
MAR 34502APR 35803MAY 32275JUN 33686JUL 33842
AUG 29410SEP 32169OCT 31004NOV 25054DEC 30004
TOTALS385606
Positive Screens
580Screen
Positivity Rate0.15%
Positive Western Blots
131WB Positivity
Rate0.03%
Western Blot Average Percentage RateNegative 70.2%
Indeterminate 7.2%Positive 14.7%
Prev/Conf 7.9%
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Hepatitis Testing
Tests Performed:
Hep A Virus AB IgM (HAV-M)
Hep A Virus AB Total (HAV-T)
Hep B Total Core AB (HBcAb-T)
Hep B Core AB IgM (HBcAb-IgM)
Hep C (HCV) AB
Hep B Surface AG (HBsAg)
AB to Hep B Surface AG(HBsAb)
Hepatitis B Envelope Ab, Ag (manual test)
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Siemens ADVIA
Centaur
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Immunodiagostics
Additional tests performed on the Centaur:
Rubella IgG, IgM
Toxoplasma IgG, IgM
Thyroid Panel
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Changes in Immunodiagnostics
Tests moving to Bioplex 2200 pending FDA approval:
Mumps IgG
Measles (Rubeola) IgG
Varicella IgG
Cytomegalovirus (CMV) IgG, IgM
Rubella IgG, IgM
Toxoplasma IgG, IgM
Lyme Disease (Borrelia burgdorferi)
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TAT-HIV
Days
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TAT-Hepatitis
0
0.5
1
1.5
2
2.5
3
Jan Feb Mar Apr May Jun July Aug Sept Oct Nov DEC
CY08 CY09
Days
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TAT-EIA
Days
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Parasitology
Manual testing
Specimen = Stool
Ova & Parasites• Trichrome Stains• Concentrations• Turn-around- time – 9 hours
Worm Identification• Turn-around-time < 24 hours
Trichuris trichiura ova
Schistosoma haematobium ova
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Parasitology
Enzyme immunoassay (EIA) for:• Giardia Specific Antigen• Crytosporidium Specific Antigen• Turn around time – 9 hours
Acid Fast Stain for:• Cyclospora species• Isospora species• Turn around time – 9 hours
Pinworm Identification• Turn around time – 9 hours
Giardia lamblia (trophozoite)
Enterobius vermicularis (ova)
E. vermicularis (adult worm)
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Virology
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Herpes Simplex Virus testing - ELVIS
Enzyme Linked Virus Inducible System A culture-based test for HSV only
ELVIS results in ~ 17 hrs
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Virology
Routine clinical specimens for viral detection
Tissue culture and fluorescent antibody stains
TAT = 2-14 days
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Influenza virus AInfluenza virus BAdenovirusParainfluenza virus 1-3Respiratory Syncytial VirusEnterovirus
TAT = 2-10 days
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Detection in tissue culture
Confirming by FA stain
Positive influenza isolates sent to Molecular Diagnostics for sequencing
Respiratory Viral Cultures
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The “Swine Flu” Team to the Rescue
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Chlamydia/GC Testing
Nucleic Acid Amplification Testing (NAAT)
Three TIGRIS walk away instruments
(Gen-Probe, Inc.)
~18,000 month (36,000 reportable results)
All positives confirmed by a supplemental test that detects a different target
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Days
TAT – GC/Chlamydia
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Molecular DiagnosticsMolecular Diagnostics
Nasal wash specimens preferred:
Allows for concurrent molecular and culture analysis
Allows for enough leftover specimen for archiving - additional testing may be requested by the CDC
Also, original specimens may be requested by the CDC for use as potential seed virus for influenza vaccine production
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Automated: easyMAG
Off board lysis (safer)
Excellent in side by side comparisons with other automated extractors (especially with stool)
Manual: RNA Ambion
Nucleic Acid Extraction Nucleic Acid Extraction
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Target Detection Target Detection
Real time RT PCR
- 7500 DX (New Norovirus)
Traditional RT PCR
- 9700 (for Sequencing)
Multiplex PCR (xTag RVP)
- Luminex (not currently utilized)
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Strain AnalysisStrain Analysis
Sanger Sequencing
Pyrosequencing
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Influenza Surge Testing
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Currently, limited bacteriology service
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Helicobacter pylori stool antigen test
Bacteriology
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H. pylori: Introduction
Isolated by Warren and Marshall from gastric biopsies in 1983
Gram-negative organism, produces urease
Prevalence varies depending on age, socioeconomic class, issues related to sanitation and hygiene, and country of origin
Causes 75% to 80% of peptic ulcer disease
Approximately 20% of people under 40 and 50% of people over 60 are infected
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H. pyloriDisease Overview
DISEASE CONTRIBUTORY ROLE FOR H. PYLORI?
EFFECT OF H. PYLORI ERADICATION
Peptic ulcer disease Yes Reduces ulcer recurrence rate
Gastric adenocarcinoma Yes Uncertain
MALT lymphoma Yes Partial or complete remission in more than half of patients
Uninvestigated dyspepsia Yes, in some patients Symptom improvement in some
Iron-deficiency anemia Likely May lead to anemia resolution when H. pylori is the cause
Idiopathic thrombocytopenic purpura Yes, in some patients Platelet count improves after eradication
Nonulcer dyspepsia Controversial Little effect, if any
NSAID-induced ulcer Controversial; perhaps only in naïve NSAID users
May reduce ulcer incidence in Asian naïve NSAID users
GERD Unlikely, at least for most patients; H. pylori may protect against GERD
Uncertain
Pancreatic cancer Uncertain Unknown
Coronary artery disease Unlikely Probably none
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* Assuming a 20% H. pylori prevalence
ACG Guidelines
The AGA released new guidelines for managing dyspepsia in 2005… and the American College of Gastroenterology revised their guidelines in 2007.
In 2007, the American College of Gastroenterology revised their guidelines to include:
"Patients 55 years of age or younger without alarm features should receive H. pylori test and treatment followed by acid suppression if symptoms remain. H. pylori testing is optimally performed by a stool antigen test or 13C urea breath test."
The test and treatment strategy for H. pylori infection is a proven management strategy for patients with uninvestigated dyspepsia who are under the age of 55 yr and have no "alarm features“.
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Both AGA and ACG now recommend that serology testing no longer be performed to test for H. pylori because it only tests for the antibody and does not test for “active” infection
The AGA and ACG guidelines do recommend using Stool Antigen Test or Urea Breath Test for the detection of H. pylori
50% of patients that have a positive serology test do not have “active” infection (false positive for active infection)
ACG Guidelines
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Why Not Serology?
Serology does not test for “active” infection - tests for antibody not antigenA patient with a false positive serology test or with positive serology but an inactive infection can lead to:
• Unnecessary treatment (and expense)• Increased antibiotic resistance• Increased incidence of side effects from
treatment• Increased patient anxiety over implications of
a positive test
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H. pylori Antigen Test
Freeze unpreserved stool specimens immediately store upon receipt at -20 C and ⁰ship frozen
Minimum volume: 5gms/5mL
Order in CHCS - Helicobacter pylori Ag
Validation contact – Ms. Annette Compton (DSN 240- 6622)
Turnaround time – 24 hours
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BRAC
Seamless transition to customers
Relocation of Immunodiagnostics first
Phase 1 – ADVON team (June & Oct 2010)
Phase 2 – December 2010
Phase 3 – January 2011
Complete relocation: May-Sep 2011
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BRAC
Upfront plans completed prior to relocation
Interop CHCS test files
Contracts – Equipment (new and reagent rental, Personnel, Supplies)
Accreditations (CAP, CDC, etc.)
OIs/SOPs, Policies, Procedures
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BRAC
Lab – Open construction of entire lab space
Design facilitates movement of specimens
Lab work areas are moveable for mission flexibility
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USAFSAM EPI Lab
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Questions?
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United States School of Aerospace MedicineEpidemiology Laboratory Service(USAFSAM/PHE)2730 Louis Bauer DriveBrooks City-Base, TX 78235-5132
EPI Lab Customer Service TeamDSN: 240-8378Commercial: 210.536.8378Email: [email protected]: https://kx.afms.mil/epi/
Distribution Statement A: Approved for public release; distribution is unlimited. 311 HSW/PA No. 09-062, 12 Feb 2009