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IPP Program Update *APTIMA Test

IPP Program Update *APTIMA Test. Oregon Infertility Prevention Project Oregon State Public Health Lab Department of Human Services June, 2009. Update Outline. The following presentation will address the following program components :

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IPP Program Update *APTIMA Test

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  1. IPP Program Update *APTIMA Test Oregon Infertility Prevention Project Oregon State Public Health Lab Department of Human ServicesJune, 2009

  2. Update Outline The following presentation will address the following program components: • 1) Nucleic Acid Amplification Testing (NAAT) - Transition to APTIMA • 2) Dual-Test – includes both CT and GC screening • 3) 3% Overall CT Positivity • 4) Client Eligibility Requirements for IPP

  3. Introducing the new CT/GC Test • IPP will be switching to a second-generation NAAT testing system. This test is called the APTIMA Combo 2 Assay and is produced by Gen-Probe • Like current platform, this assay can test for CT and GC using only one sample but it allows sites more flexibility for transport and specimen types.

  4. Male Urethral Swabs Female Urines Male Urines Endocervical Swabs Vaginal Swabs – Clinician collected Vaginal Swabs – Patient collected The New Test (continued)This test is FDA approved for the following specimen types:

  5. Once in the collection tube - transport time and temperature for all specimens is extended to 30 days at room temperature (but please send them sooner). The New Test (continued)

  6. Specimen Collection Guidelines • Vaginal Specimen Collection • Urine Specimen Collection • Endocervical Swab specimen collection

  7. REMEMBER • The better the specimen you collect, the better the result you get back. Nucleic Acid Amplification Tests are very sensitive to contamination. Please use good technique such as not setting caps down on the countertop and not saving urines to aliquot all at one time as this increases the risk of cross-contamination and potential false positive results.

  8. Vaginal Swab Collection The following steps should be closely followed by patients and providers: 1. Open the vaginal swab collection kit -included: 1 vaginal specimen collection swab, and 1 tube containing Gen-Probe APTIMA swab transport media

  9. Vaginal Swab Collection 2. Remove tube from package and place in test tube rack. Remove cap from test tube without touching the inside of the cap or tube, set the removed cap upside down on the counter until placing it back on the test tube Note: tube must remain upright until capped

  10. Vaginal Swab Collection 3. Remove swab package from collection kit 4. Open the swab package from collection kit

  11. Vaginal Swab Collection 5. Remove the swab; do not touch the soft tip or lay the swab down 6. Hold the swab as shown:

  12. Vaginal Swab Collection 7. Insert the swab into your vagina about two inches as shown: 8. Gently rotate the swab for 10 to 30 sec in the vagina

  13. Vaginal Swab Collection 9. Withdraw the swab without touching the skin 10. Place the swab into the test tube so that the tip of the swab is visible as shown:

  14. Vaginal Swab Collection 11. Break the swab shaft against the side of the test tube as shown; use care to avoid splashing the contents of the tube. If tube is dropped, contents spilled, or if the swab flips out of the tube, notify clinic staff

  15. Vaginal Swab Collection 12. Re-cap the tube tightly as shown:

  16. Collection and Storage Swab specimens must be transported to the laboratory in the swab specimen transport medium and tube. Swab specimens must be transported to the laboratory at 2°C to 30°C (35.6°F to 80°F) and tested within 30 days of collection

  17. Female/Male Urine Collection The following steps should be closely followed by providers:

  18. Female/Male Urine Collection *Note: Collection of larger volumes of urine than suggested may result in specimen dilution that may reduce test sensitivity. Female patients should not cleanse labial area prior to providing specimen *Note: The patient should NOT have urinated for at least 1 hour prior to specimen collection

  19. Female/Male Urine Collection 1. Direct patient to provide first catch urine (approx. 15 to 30 ml of initial urine stream) into a urine collection cup free of any preservatives.

  20. Female/Male Urine Collection 2. Remove cap from urine specimen transport tube and transfer 2 ml of urine into urine specimen transport tube using disposable pipette provided. The correct volume of urine has been added when fluid level is between black fill lines on urine tube label

  21. Female/Male Urine Collection 3. Re-cap urine specimen transport tube tightly. This is now known as the “processed urine specimen”

  22. Female/Male Urine Collection *Note: Do not remove or puncture the foil seal on top of the test tube lid. This is only removed by the lab during sample testing

  23. Collection and Storage Urine specimens can be transported to the laboratory at 2°C to 30°C (35.6°F to 80°F) in the urine specimen transport tube. Urine specimens must be transferred into the APTIMA specimen transport tube within 24 hours of collection; however, it is RECOMMENDED that urine be transferred within 1 hr after collection. After transfer, urine specimens can be stored at 2°C to 30°C for up to 30 days after collection

  24. Endocervical Swab Collection The following steps should be closely followed by providers: 1. Remove excess mucus from cervical os and surrounding mucosa using cleaning swab (white shaft in package with red printing). *Discard this swab

  25. Endocervical Swab Collection 2. Insert specimen collection swab (blue shaft swab in package with green printing) into endocervical canal.

  26. Endocervical Swab Collection 3. Gently rotate swab clockwise for 10 to 30 seconds in endocervical canal to ensure adequate sampling. 4. Withdraw swab carefully; avoid any contact with vaginal mucosa.

  27. Endocervical Swab Collection 5. Remove cap from swab specimen transport tube and immediately place specimen collection swab into specimen transport tube 6. Carefully break swab shaft at score-line; use care to avoid splashing contents. 7. Re-cap swab specimen transport tube tightly

  28. Collection and Storage Endocervical specimens should be transported and stored in specimen transport tube at 2°C to 30°C (35.6°F to 80°F) until tested. Specimens must be assayed with the APTIMA Assay for CT and GC within 60 days of collection.

  29. Male Urethral Swab Collection The following steps should be closely followed by providers: 1. Insert specimen collection swab (blue shaft swab in package with green printing) 2 to 4 cm into urethra

  30. Male Urethral Swab Collection 2. Gently rotate swab clockwise for 2 to 3 seconds in urethra to ensure adequate sampling. 3. Withdraw swab carefully. 4. Remove cap from swab specimen transport tube and immediately place specimen collection swab into specimen transport tube.

  31. Male Urethral Swab Collection 5. Carefully break swab shaft at scoreline; use care to avoid splashing contents. 6. Re-cap swab specimen transport tube tightly.

  32. Storage and Collection Urethral specimens should be transported and stored in specimen transport tube at 2°C to 30°C (35.6°F to 80°F) until tested. Specimens must be assayed with the APTIMA Assay for CT and GC within 60 days of collection.

  33. Specimen Tube Information As requested by the laboratory: • Do not place labels over the window of the black fill lines where urine volume is shown • Place label vertically along the length of the test tube, rather than around • Write the second patient identifier on the label first, and then place label on the test tube

  34. Important Reminders • Do not allow any fluid to escape from uncapped collection/transport tubes – they should be held upright • Screw cap back onto collection/transport tubes tightly • Do not pierce foil on top of collection device!!

  35. Collection and Storage All samples from the APTIMA test can be transported at room temperature. Refrigeration of samples is also acceptable.

  36. APTIMA Test For those who are interested in the laboratory process, this is a simplified version of how the test works: • 1. Specimens are collected and transported in their respective tubes. Each tube contains a solution that releases the nucleic acid targets and protects the specimen from degrading during transport and storage • 2. At the lab, any target nucleic acid, e.g., CT and GC, is amplified/replicated

  37. APTIMA Test II • 3. Detection: amplified target nucleic acid combines with complementary probes supplied in the kit and results in the formation of RNA:DNA hybrids, which when reacted with another molecule, emit light which is measured by a luminometer. • 4. The luminometer reports a specific wavelength for positive CT result, and a different wavelength for a positive GC result *If you would like more information on the test, visit: http://www.gen-probe.com/pdfs/pi/501011RevD.pdf

  38. Don’t forget your submitter code New Concurrent sex partner section: Is your client having sex with their partner, who might be having sex with someone else? New label section: Don’t tear off. Use either of the first two labels for the test tube and leave any extras. New Lab Form

  39. New Lab Form II • There need to be two identifiers on the specimen. First is the form ID number (on the labels at the bottom of the form), and the second must be filled in by providers. The second identifier can be: • DOB • Name • Patient ID number

  40. New Lab Form III • Do not detach the perforated section of the form that includes the labels with barcodes. The unused barcodes will be sent back to the lab, where they may be used • File the green copy in the client’s medical chart in the “Lab” section. Leave the pink for Ahler’s and the white for the lab.

  41. New Lab Form IV • Do you have a patient that doesn’t meet IPP criteria?? You can now order a GC/Chlamydia test on a non-IPP patient by using our regular Virology/Immunology Request form. The cost will be $16 - $18. For more information, please contact Terry Crandall or Chris Biggs. terry.crandall@state.or.us or christianne.biggs@state.or.us .

  42. Virology / ImmunologyForm • HIV Testing for NON-CTS patients • Hepatitis Testing • Specific Marker • Reason (carrier, prenatal, etc) • GC /CT for non-IPP Clients • Billable Test • Peel-off Barcode Labels

  43. Old Testing Kits • The old PCR and Digene testing kits can no longer be used after APTIMA testing is implemented at your site. The lab will no longer be able to process the old test kits. Any specimens sent to the lab in these old kits will not be processed.

  44. Patient Test Results • Initial Results

  45. Test Results • If the client’s specimen test result is negative, the lab will report the result as Presumptive Negative for CT and/or GC • If a client’s specimen test result is positive, equivocal, or invalid the lab will retest the specimen. Invalid and Equivocal results often resolve when the specimen is retested.

  46. Test Results: Positive or Negative CT and/or GC FirstTest Negative Positive Equivocal Invalid Retest Retest Positive Negative See next slide Presumptive Negative Positive Indeterminate FINAL RESULT

  47. Patient Test Results • Retest Results for Equivocal and Invalid specimens

  48. FINAL Test Results • The final test result will be reported to the IPP partner screening sites as: • Positive • Presumptive Negative • Indeterminate, please recollect • There will be two results, one for CT and a separate result for GC.

  49. Indeterminate Results: CT/GC There are two explanations for an ‘Indeterminate’ test result: • Equivocal or Invalid initial test result that repeats as Equivocal or Invalid on retest. • Initial positive test result that is negative on retest.

  50. Sensitivity and Specificity

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