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Mohammad Al-Ghoul Joe Lyons Marian Tully CDD Updates on Specimen Collection & Processing.

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Presentation on theme: "Mohammad Al-Ghoul Joe Lyons Marian Tully CDD Updates on Specimen Collection & Processing."— Presentation transcript:

1 Mohammad Al-Ghoul Joe Lyons Marian Tully CDD Updates on Specimen Collection & Processing

2 Center for Disease Detection Mohammad Al-Ghoul

3 Agenda New tests implemented by CDD New HIV testing algorithm 4th generation HIV test HIV-1/HIV-2 Discriminatory assay (Multispot test) CT/GC testing using cobas 4800 system Toxicology testing process and test changes Recent changes with CDD processes and tubes used Tips for optimal sample collection List of tests available Q & A

4 HIV New Testing Algorithm Advantages of using the fourth generation HIV assay Advantages of using the HIV-1/HIV-2 Discriminatory assay (Multispot test) Explain the new testing algorithm

5 Ability to Detect HIV Infection Earlier 4th Generation HIV Assay FDA-approved in June 2010 The first diagnostic assay that: Detects HIV antibodies and HIV-1 p24 antigen Can be used on children ≥ 2 years A new testing algorithm that replaces WB test with Multispot

6 Viral Load by HIV RNA or other NAAT 4 th – generation (p24 Ag+Ab Combination) EIA HIV Antibody 3 rd gen days, Infection Undetectable: No tests to close the gap HIV Abs HIV RNA HIV p24 Ag Acute retroviral symptoms 4 th generation improvement days 50% of new HIV infections acquired from persons with Acute HIV Infection (Day 0 – Day 20) (Days) 4 th Generation HIV Assay Detects Infection in Acute Phase

7 Advantages of 4th Gen. Assay Detects HIV-1/-2 antibodies and HIV-1 p24 antigen simultaneously Identifies HIV infection 2-20 days earlier than HIV antibody tests alone Detects acute, as well as latent infections using a time and cost-saving strategy.

8 Western Blot Vs. Multispot Western BlotMultispot HIV-1 Positive: Preliminary positive for HIV-1 Ab HIV-1 Negative: No Ab detected for HIV-1 Indeterminate: Repeat testing or collect another specimen and send for NAAT testing HIV-1 Positive: Preliminary Positive for HIV-1 Antibodies and HIV-1 P24 Ag HIV-2 Positive: Preliminary positive for HIV-2 antibodies Indeterminate: Collect another specimen and send for NAAT testing HIV Positive (Undifferentiated) Additional testing recommended

9 Limitations of Current Algorithm Antibody tests do not detect infection in ~10% of infected persons at highest risk of transmission Cannot detect acute infections and misclassifies approximately 60% of HIV-2 infections as HIV-1, based on HIV-1 WB results. Three day turnaround time for confirmation Detection of Acute HIV Infection in Two Evaluations of a New HIV Diagnostic Testing Algorithm — United States, 2011–2013, CDC, MMWR June 21, 2013 / 62(24);

10 Characteristics of an Ideal HIV Diagnostic Algorithm Detects HIV acute and latent infections Differentiates HIV-1 from HIV-2 Eliminates indeterminate results due to cross reactivity of HIV-2 Ab with HIV-1 WB Reduces the diagnostic window Faster turnaround times

11 A1: 4 th generation HIV-1/2 immunoassay A2: HIV-1/HIV-2 differentiation immunoassay (Multispot) A1(-) Negative for HIV-1 and HIV- 2 antibodies and p24 Ag A1+ HIV-1 + HIV-1 antibodies detected Initiate care HIV-2 + HIV-2 antibodies detected Initiate care HIV-1&2 (-) RNA RNA+ Acute HIV-1 infection Initiate care RNA (-) Negative for HIV-1 Proposed in March 2010 CDC APHL HIV Diagnostic conference Repeat in duplicate New HIV Diagnostic Algorithm

12 Conclusion Earlier detection of infection Differentiation between HIV-1 and HIV-2 Faster turnaround times for reports

13 Agenda New tests implemented by CDD New HIV testing algorithm 4th generation HIV test HIV-1/HIV-2 Discriminatory assay (Multispot test) CT/GC testing using cobas 4800 system Toxicology testing process and test changes Recent changes with CDD processes and tubes used Tips for optimal sample collection Test List Q & A

14 CT/GC Testing: New Methodology The cobas 4800 system recently approved by the FDA to test for HPV and CT/GC Increased Sensitivity/Specificity Provides inhibitory control

15 Sexually Transmitted Diseases Treatment Guidelines, 2010; CDC, December 17, Vaginal swabs: preferred specimen type for testing using NAAT Urine: preferred specimen type for testing males using NAAT CDC Screening Recommendations CT/NG Specimen Types

16 Testing for CT/GC by the Following Vaginal Swab (Clinical Setting) Collector Stability (RT 365 days) Urine Collector Stability (RT 365 day) PreservCyt (ThinPrep) Collector Stability (RT 21 days) CT/GC results are reported within 24 hours of specimen receipt

17 Vaginal Swab Rejection Criteria 10% 5% 2.5% No Blood Reject cobas ® vaginal swab specimens for CT/NG testing if the whole blood concentration is >10.0% (dark red or brown coloration).

18 Urine Rejection Criteria 0.35% 0.175% 0.083% No Blood Reject cobas ® Urine specimens for CT/NG testing if whole blood concentration is >0.35%.

19 PreservCyt (ThinPrep) Rejection Criteria 1.5%0.75%0.037%No Blood Compare PreserveCyt ® specimens to the images above. Reject specimens for CT/GC testing if whole blood concentration is >1.5%.

20 Agenda New tests implemented by CDD New HIV testing algorithm 4th generation HIV test HIV-1/HIV-2 Discriminatory assay (Multispot test) CT/GC testing using cobas 4800 system Toxicology testing process and test changes Recent changes with CDD processes and tubes used Tips for optimal sample collection Test List Q & A

21 More than 70% of lab errors are due to specimen collection issues Reliability and Validity of Urine Toxicology Specimen

22 Urine Drug Testing Limitation Urine drug testing only indicates prior use Not useful for determining: Time since last use Extent/frequency of use Additional use since last positive test Current impairment

23 Testing Methods Screening: Enzyme Immunoassay (EIA) Confirmation: Gas Chromatography/Mass Spectrometry (GC/MS) “Gold-Standard” for Drug Testing NO BIOLOGICAL FALSE POSITIVES

24 Negative screening results are released the same day the specimen is received at CDD NEW Toxicology orders now have their own accession numbers. Test Menu and Turnaround Times Job Corps Toxicology Panel AMP/Meth-AMP Panel (72h) Cannabinoids (48h) Cocaine (48h) Opiates (72h) PCP (48h)

25 Spice/K2 K2 or Spice is a mixture of herbs, spices or shredded plant material that is typically sprayed with a synthetic compound chemically similar to THC At least 41 states and Puerto Rico have legislatively banned synthetic cannabinoids

26 JWH-133 JWH-018 "People who use it are idiots.” "You don't know what it's going to do to you." John W. Huffman, PhD

27 Spice Test (Synthetic Cannabinoids) Current test detects three metabolites JWH-018 M5 JWH-018 M6 JWH-073 M6

28 New Spice Test Screening Detected / Non detected Confirmation for 16 separate metabolites AM2201, AM694, JWH 018, JWH 019, JWH 073, JWH 081, JWH 122, JWH 203, JWH210, JWH 250, JWH 398, MAM 2201, RCS-4, 2XUR-144, XLR11

29 Agenda New tests implemented by CDD New HIV testing algorithm 4th generation HIV test HIV-1/HIV-2 Discriminatory assay (Multispot test) CT/GC testing using cobas 4800 system Toxicology testing process and test changes Recent changes with CDD processes and tubes used Tips for optimal sample collection Test List Q & A

30 Center for Disease Detection Joe Lyons

31 Sample Collection Devices Blood Collectors Urine Collectors Swab Collection Device

32 7.5 mL Tiger Top No Fill Line Mark Additive – serum clot activator Blood Collection Devices

33 Fill Mark 10% Above 10% Below 4 mL SST and Red Top Additive – serum clot activator Blood Collection Devices

34 Fill Mark 10% Above 10% Below 3 mL Purple Top CBC, H/H Sample Fill Line Additive - Ethylenediaminetetraacetic acid (EDTA) Blood Collection Devices

35 Yellow Top TOX and NY CT/GC Sample fill line No Additive No fill requirement other than amount necessary to run test Fill Mark Urine Collection Devices

36 Red and Yellow Top Sample fill lines (stay within lines) Additive – urine preservative Do Not Exceed this line Do Not fill lower than this line Urine Collection Devices

37 cobas® PCR Urine collector Sample fill lines (stay within lines) Additive – PCR media A drop DOES NOT make a difference Do not exceed this line Do not fill lower than this line Urine Collection Devices

38 cobas® PCR Female Swab Patient collected Sample fill lines NOT used Additive – PCR media Discard extra swab Swab down (bacteria in media) Swab Collection Device

39 The best result begins with the SPECIMEN Women – Vaginal specimenMen – Urine Specimen Does not require use of the cleaning swab Discard one swab Insert one swab approximately 2 inches into the vagina Gently turn the swab for about 30 seconds while rubbing the swab against the wall of the vagina Remove swab and place into the cobas® PCR media tube Break shaft at etch mark and recap tube Note: Swab must be at bottom of tube Patient should not urinate 1 hour prior to sampling Collect urine at the beginning of the urine stream. This is not a mid- stream collection. Collect first 10 to 50 mL of urine, additional volume may begin to dilute the specimen Transfer appropriate volume of urine to the cobas® PCR media tube

40 Place arm in a downward position. Phlebotomy Tips

41 Use an insertion angle of 10 to 20 degrees. Phlebotomy Tips

42 A frequent cause of no blood flow is that the tip is no longer in the vein lumen. Phlebotomy Tips

43 Make a fist, do not pump (pumping increases potassium) Avoid tapping the venipuncture site Warm the venipuncture site Wait an extra few seconds when it appears blood flow has stopped Ensure all additive tubes are gently rocked 8-10 times

44 Phlebotomy Tips To avoid Hemolysis Do not apply tourniquet too tightly or for too long. Do not shake the sample instead gently rock it 8-10 times. Do not delay separation of cells from serum by centrifugation(>3 hours) Too long or too high centrifugation

45 Agenda New tests implemented by CDD New HIV testing algorithm 4th generation HIV test HIV-1/HIV-2 Discriminatory assay (Multispot test) CT/GC testing using cobas 4800 system Toxicology testing process and test changes Recent changes with CDD processes and tubes used Tips for optimal sample collection Test List Q & A

46 Center for Disease Detection Marian Tully

47 Account Managers Barbara Castro, Account Manager (888) , Ext. 236 Veronica Rodriguez, Account Manager (888) , Ext. 250 Marian Tully, Sr. Account Manager (888) , Ext. 208

48 Note: The Department of Labor is only contracted for Chlamydia, HIV and Toxicology. List of Tests

49 Helpful Links

50 Thank You


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