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CHLAMYDIA TRACHOMATIS TEST What are the other names for this test? Chlamydia Nucleic Acid Amplification Test, Chlamydia/GC STD Panel, Chlamydia NAAT Test, Chlamydia Culture, Chlamydia test What is a chlamydia trachomatis test? The Chlamydia trachomatis test helps to see chlamydia in your fluid sample from your body. Chlamydia is one of the significant sexually transmitted infections (STIs) developed by the chlamydia trachomatis bacteria. Chlamydia is most common in the US and often spreads through vaginal, oral, and anal sex. If chlamydia is left untreated, it may result in health problems, such as infertility and inflammation in your pelvis. Many tests are available to detect chlamydia, such as molecular testing known as Nucleic Acid Amplification Test (NAAT) and cell culture. NAAT is the most common procedure for identifying a chlamydia infection. This test helps to diagnose the genetic material (DNA or RNA) of chlamydia trachomatis. What is the purpose of this test? A chlamydia trachomatis test screens and diagnoses the chlamydia through the samples, such as urine and fluid swabs from the vagina, throat, eyes, rectum, or cervix. Your provider collects your sample that depends on where the infection is present. This test may also perform after three months of treatment to observe for re-infection. In women, chlamydia may indicate cervicitis, swelling, and inflammation in the cervix. The cervix is the part of the lower and narrow end of the uterus that creates a waterway between the uterus and the vagina. Infected women with chlamydia may also develop endometriosis. This condition leads to the production of cells similar to the lining of the uterus outside the uterus. Babies may have a lung or eye infection if mothers have an infection. In men, chlamydia may lead to urethritis. It is a condition of urethra swelling and the rare chance of blood in the urine. When do I need to take this test? Most people infected with chlamydia do not have symptoms. Your healthcare provider depends on screening to identify most cases of chlamydia. Screening may perform based on your sexual activity and health. According to the Centers for Disease and Control Prevention (CDC), this test specifically recommends for sexually active people aged 15 to 24 at least once a year. This test may also suggest to those who have: A new sex partner or having more than one. Sex partners who involve in sex with other persons Sex from an infected person with STD Diagnosed with HIV infection Sex with the same genders or sex with other people with a penis. Become pregnant under age 25 and above 25 with high risks of chlamydia infection. Your healthcare provider may recommend a chlamydia trachomatis test if your sex partner experiences chlamydia. Some symptoms of chlamydia develop in women may include: Pain during sex Difficulty or pain while urinating Pain in the rectum Stomach pain Abnormal discharge or bleeding from the vagina Symptoms of chlamydia in men may include: Difficulty or pain while urinating Discharge from your penis Swelling in the scrotum Pain in the rectum Pain in your testicles Your provider will ask you to test for chlamydia after three months of treatment to see for a new infection. It is because repeat infections are often common in people. You can review your test result with an online meetup from your provider. What is the procedure for this test? Your provider will ask for a fluid sample from your infected body’s part for a chlamydia trachomatis test. Two ways are available to collect fluid sample are: A first-catch urine sample A sterile cup requires you to collect urine from the first part of the urine stream. You may need to stop urinating before the test for at least two hours to receive accurate results. A swab sample Your provider will collect cells from your genital area (the urethra or the vagina) with a special swab. You may feel some discomfort. Your rectum, throat, cervix, or eyes may swab. Your provider may ask you to swab yourself with specific instructions. You may receive your test results within a day. Some chlamydia trachomatis tests may provide results within 90 minutes or less. If you have symptoms of chlamydia, you may order an online test for chlamydia. You can also order a swab or urine sample at home. You can send the sample to your laboratory after collecting the sample. You should avoid testing at home if you see symptoms of chlamydia or your sex partner experiences chlamydia. You need to consult with a provider about taking a chlamydia test. How do I need to prepare for this test? You may need preparation for a chlamydia trachomatis test that depends on the sample type. You should avoid antibiotic medicines and vaginal creams for 24 hours before your test. You can ask your provider about the specific preparation required for this test. Are there any risks involved in this test? A chlamydia trachomatis test does not have any risk. What do the test results indicate? The test results depend on many factors, such as age, gender, and medical history. The test results may also slightly differ among laboratories. It is because each lab may use different methods for examination. The negative results indicate that you have no chlamydia in your fluid sample. A positive test result means that you have an infection with chlamydia bacteria. When you have a positive test result, your provider will give you antibiotics to cure your infection. You need to follow specific instructions provided by your doctor to ensure that you have no chlamydia. What additional tests do I need along with this test? Your healthcare provider may suggest taking other tests because chlamydia symptoms may confuse with other STI symptoms. These STIs are: Syphilis Hepatitis B HIV/AIDS Gonorrhea Trichomoniasis What else do I need to know about a chlamydia trachomatis test? This test may help eliminate health problems and resist the disease from spreading. You may avoid or prevent chlamydia or any STD by not doing oral, vaginal, or anal sex. You can eliminate your risk of chlamydia if: You are sexually active with only one partner and possess negative test results for STD You use condoms each time you do sex.
"Clinical Significance Chlamydia trachomatis RNA, TMA, Throat - Chlamydia trachomatis may infect the oral/pharyngeal cavity of sexually active individuals. Detection of this organism may be important for determining the risk for disease progression or transmission. Preferred Specimen(s) Throat swab in APTIMA® Combo 2 Transport Media Collection Instructions Note: Results from the APTIMA® Combo 2 Assay should be interpreted in conjunction with other laboratory and clinical data available to the clinician. The APTIMA® Combo 2 Assay is not intended for the evaluation of suspected sexual abuse or for other medico-legal indications. For a complete list of assay limitations we recommend that you review the manufacturers package insert, https://www.hologic.com/package-inserts/diagnostic-products/aptima-combo-2-assay-ctng Use the ATPIMA® Unisex Swab Specimen Collection kit (white label) or APTIMA® Vaginal Swab Specimen Collection kit (orange label). Using a tongue depressor, insert the small, blue shafted collection swab (Unisex kit, NOT the larger white shafted cleansing swab) or the small pink shafted collection swab (Vaginal kit) and vigorously rub the tonsils and the posterior pharynx. Carefully remove the swab without touching any area of the mouth. Remove the cap from the swab specimen transport tube and immediately place the swab into the transport tube. Carefully break the swab shaft at the score line. Re-cap the swab specimen transport tube tightly, label and ship to the lab. IMPORTANT: Please review the Specimen Collection instructions SPECIMEN COLLECTION GUIDES FOR APTIMA for this test Transport Container APTIMA® Transport Tube Transport Temperature Room temperature Specimen Stability Room temperature: 30 days Refrigerated: 30 days Frozen: 30 days Reject Criteria Transport tubes with 2 swabs • Transport tubes with non-APTIMA® swabs • Specimens in broken containers • Swab submitted in M4 transport media • Swabs submitted in Viral Culture Media (V-C-M) Methodology Transcription-Mediated Amplification (TMA) Assay Category The analytical performance characteristics of this assay have been determined by Quest Diagnostics. The modifications have not been cleared or approved by the FDA. This assay has been validated pursuant to the CLIA regulations and is used for clinical purposes. Reference Range(s) Not detected Alternative Name(s) CT APTIMA®,CT TMA
"Clinical Significance Chlamydia trachomatis RNA, TMA, Urogenital - C. trachomatis infections are the leading cause of sexually transmitted diseases in the united states. C. trachomatis is known to cause cervicitis, pelvic inflammatory disease (PID), epididymitis and proctitis. It is also the most frequent cause of non-gonococcal urethritis in men. Among women, the consequences of chlamydial infections are severe if left untreated. Approximately half of chlamydial infections are asymptomatic. Preferred Specimen(s) 1 vaginal swab in Aptima® Transport Tube 1 endocervical or urethral swab in Aptima® Transport Tube 2 mL urine in Aptima® Transport Tube 1 mL liquid cytology (PreservCyt®) preservative (ThinPrep®) in Aptima® Transfer Tube 0.5 mL SurePath™ preservative fluid in Aptima® Transfer Tube Minimum Volume 1 vaginal swab in Aptima® Transport Tube 1 endocervical or urethral swab in Aptima® Transport Tube 2 mL urine in Aptima® Transport Tube 1 mL PreservCyt® (ThinPrep®) in Aptima® Transfer Tube 0.5 mL SurePath™ fluid in Aptima® Transfer Tube Collection Instructions Vaginal Swab: Follow instructions in the Aptima® Vaginal Swab Collection or Multitest Collection Kit (orange label). Endocervical or Urethral Swab: Follow instructions in the Aptima® Unisex Swab Specimen Collection Kit (white label). In females, to ensure collection of cells infected with C. trachomatis, columnar epithelial cells lining the endocervix should be obtained. Excess mucus should be removed prior to sampling. Urine: Direct patient to provide a first-catch urine (a maximum of 20-30 mL of the initial urine stream) into a urine collection cup free of any preservatives. 2 mL of urine specimen must be transferred into the Aptima® Specimen Transport within 24 hours of collection and before being assayed. Use the tube provided in the urine specimen collection kit. The fluid (urine plus transport media) level in the urine transport tube must fall within the clear pane of the tube label. Labs performing cytology: Aliquot PreservCyt® ThinPrep® solution before performance of liquid based cytology testing. PreservCyt® ThinPrep®: Transfer 1 mL PreservCyt® ThinPrep® solution into Aptima® Specimen Transfer Tube (green label) or Aptima® Vaginal Collection or Multitest Collection Tube (orange label) or Unisex Swab Specimen Collection Kit (white label). SurePath™: SurePath™ fluid must be transferred to Aptima® tube within 4 days of collection. Transfer 0.5 mL SurePath™ solution into Aptima® Specimen Transfer Tube (green label) or Aptima® Vaginal Collection or Multitest Collection Tube (orange label) or Unisex Swab Specimen Collection Kit (white label). Note: Results from the Aptima® combo 2 assay should be interpreted in conjunction with other laboratory and clinical data available to the clinician. The Aptima® combo 2 assay is not intended for the evaluation of suspected sexual abuse or for other medico-legal indications. For a complete list of assay limitations we recommend that you review the manufacturers package insert, https://www.hologic.com/package-inserts/diagnostic-products/aptima-combo-2-assay-ctng. IMPORTANT: Please review the Specimen Collection instructions SPECIMEN COLLECTION GUIDES FOR APTIMA for this test Transport Container Aptima® Transport Tube Transport Temperature Room temperature Specimen Stability PreservCyt(R) (ThinPrep®) in Aptima® Transport Tube Room temperature: 14 days Refrigerated: 30 days Frozen: 1 year Liquid cytology (PreservCyt® Preservative (ThinPrep®)) Room temperature: 30 days Refrigerated: 30 days Frozen: 1 year SurePath™ Preservative Fluid Room temperature: 14 days Refrigerated: 14 days Frozen: Unacceptable Urine in Aptima® Transport Medium Room temperature: 30 days Refrigerated: 30 days Frozen: 1 year Swabs in Aptima® Transport Room temperature: 60 days Refrigerated: 60 days Frozen: 1 year Methodology Transcription-Mediated Amplification (TMA) Assay Category The analytical performance characteristics of this assay have been determined by Quest Diagnostics. The modifications have not been cleared or approved by the FDA. This assay has been validated pursuant to the CLIA regulations and is used for clinical purposes. Reference Range(s) Not detected Alternative Name(s) CT APTIMA®,CT TMA
"Clinical Significance Chlamydia trachomatis, TMA (Alternate Target), Urogenital - Several methods are available for the detection of C. trachomatis in clinical specimens, including giemsa staining of tissue, fluorescent antibody staining, culture, and nucleic acid detection. Although culture is very specific, it lacks sensitivity, so recommendations have been put forth to include multiple tests in assisting with a diagnosis of infection, including tests such as the CT/NG APTIMA® TMA Assay. Preferred Specimen(s) 1 vaginal, endocervical or urethral swab collected in an APTIMA® Vaginal Swab Specimen Collection kit or Multi-Test collection kit, or Unisex swab specimen collection kit or 2 mL urine with no preservative transferred into an APTIMA® urine collection kit or 1 mL PreservCyt® (ThinPrep®) transferred into APTIMA® Specimen Transfer tube (green label) or APTIMA® Vaginal Swab Specimen Collection kit or Multi-Test collection kit Collection tube (orange label) Collection Instructions Swabs: Swab must be submitted in APTIMA® Vaginal Swab Specimen Collection kit or Multi-Test collection kit, or Unisex Swab Specimen Collection tube. Follow instructions in the APTIMA® Specimen Collection Kits for Vaginal, Endocervical and Urethral Swab Specimens package insert. In females, to ensure collection of an adequate specimen, columnar epithelial cells lining the endocervix should be obtained. To that effect, excess mucus should be removed prior to sampling by using the white shaft cleaning swab which is discarded after use. Collection Container: APTIMA® Vaginal Swab Specimen Collection kit or Multi-Test collection kit, or Unisex Swab Specimen Collection Kit. Urine: Urine must be submitted in APTIMA® Urine Specimen Collection tube within 24 hours of collection. The patient should not have urinated for at least one hour prior to specimen collection. Direct patient to provide a first-catch urine (approximately 20-30 mL of the initial urine stream) into a urine collection cup free of any preservatives. Collection of larger volumes of urine may result in specimen dilution that may reduce test sensitivity. Female patients should not cleanse the labial area prior to providing the specimen. Thus, a urine sample collected from a female for Chlamydia/GC TMA cannot be collected at the same voiding event as that urine which would be intended for bacterial culture. Remove the cap of the APTIMA® Urine Specimen Collection tube and transfer 2 mL of urine into the urine specimen transport tube using the disposable pipette provided. The correct volume of urine has been added when the fluid level is between the black lines within the clear pane on the urine specimen transport tube label. Collection Container: APTIMA® Urine Specimen Collection Kit. PreservCyt® (ThinPrep®): Transfer 1 mL of PreservCyt® (ThinPrep®) solution into APTIMA® Specimen Transfer tube (green label) or APTIMA® Vaginal Swab Specimen Collection Kit or Multi-Test collection kit Collection tube (orange label). IMPORTANT: Please review the Specimen Collection instructions SPECIMEN COLLECTION GUIDES FOR APTIMA for this test Transport Container APTIMA® transport tube Transport Temperature Room temperature Specimen Stability Endocervical, urethral and vaginal swabs Room temperature: 60 days Refrigerated: 60 days Frozen: 1 year Urine in APTIMA® urine collection kit Room temperature: 30 days Refrigerated: 30 days Frozen: 1 year PreservCyt® solution specimen in APTIMA® Room temperature: 14 days Refrigerated: 30 days Frozen: 1 year Reject Criteria Transport tubes with 2 swabs • Non-APTIMA® transport tubes and swabs • Transport tubes containing white cleaning swabs • Over or underfilled APTIMA® urine tubes Methodology Dual Kinetic Assay (DKA) • Target Capture • Transcription-Mediated Amplification (TMA) Reference Range(s) Not detected Alternative Name(s) CT APTIMA®,CT TMA
"Clinical Significance Chlamydia/Neisseria gonorrhoeae RNA, TMA, Rectal - Both Chlamydia trachomatis and Neisseria gonorrhoeae may infect the anal/rectal canal of sexually active individuals. Detection of this organism may be important for determining the risk for disease progression or transmission. Preferred Specimen(s) 1 rectal swab in Aptima® Transport Tube Minimum Volume 1 rectal swab in Aptima® Transport Collection Instructions Use the Aptima® Unisex Swab Specimen Collection Kit (white label) or Aptima® Vaginal Swab Specimen Collection Kit or Multi-test Collection Kit (orange label). Insert the small, blue-shafted collection swab (unisex kit, not the larger white-shafted cleansing swab) or the small, pink-shafted swab (vaginal kit) approximately 3-5 cm into the rectum. Rotate swab against the rectal wall at least 3 times. Withdraw the swab carefully. Swabs that are grossly contaminated with feces should be discarded and the collection repeated. Remove the cap from the swab specimen transport tube and immediately place the swab into the transport tube. Carefully break the swab shaft at the score line. Re-cap the swab specimen transport tube tightly, label and ship to the lab. Note: Results from the Aptima® Combo 2 Assay should be interpreted in conjunction with other laboratory and clinical data available to the clinician. The Aptima® Combo 2 Assay is not intended for the evaluation of suspected sexual abuse or for other medico-legal indications. For a complete list of assay limitations we recommend that you review the manufacturers package insert, https://www.hologic.com/package-inserts/diagnostic-products/aptima-combo-2-assay-ctng IMPORTANT: Please review the Specimen Collection instructions SPECIMEN COLLECTION GUIDES FOR APTIMA for this test Transport Container Aptima® transport tube Transport Temperature Room temperature Specimen Stability Room temperature: 30 days Refrigerated: 30 days Frozen: 30 days Reject Criteria Transport tubes with 2 swabs • Transport tubes with non-Aptima® swabs • Swab transport tubes with no swab • Specimens in broken containers • Swabs submitted in viral transport media Methodology Transcription-Mediated Amplification (TMA) Assay Category The analytical performance characteristics of this assay have been determined by Quest Diagnostics. The modifications have not been cleared or approved by the FDA. This assay has been validated pursuant to the CLIA regulations and is used for clinical purposes. Reference Range(s) C. trachomatis TMA, Rectal Not detected N. gonorrhoeae TMA, Rectal Not detected Alternative Name(s) CT/NG Aptima,CT/GC Aptima,CT/GC TMA,CT/NG TMA
"Clinical Significance Chlamydia/Neisseria gonorrhoeae RNA, TMA, Throat - Both Chlamydia trachomatis and Neisseria gonorrhoeae may infect the oral/pharyngeal cavity of sexually active individuals. Detection of this organism may be important for determining the risk for disease progression or transmission. Preferred Specimen(s) 1 throat swab in Aptima® Transport Tube Minimum Volume 1 throat swab in Aptima® Transport Tube Collection Instructions Use the Aptima® Unisex Swab Specimen Collection Kit (white label) or Aptima® Vaginal Swab Specimen Collection Kit or Multi-test Collection Kit (orange label). Using a tongue depressor, insert the small, blue-shafted collection swab (unisex kit, not the white-shafted cleansing swab) or the small pink-shafted collection swab (vaginal or multi-test kit) and vigorously rub the tonsils and the posterior pharynx. Carefully remove the swab without touching any area of the mouth. Remove the cap from the swab specimen transport tube and immediately place the swab into the transport tube. Carefully break the swab shaft at the score line. Re-cap the swab specimen transport tube tightly, label and ship to the lab. Note: Results from the Aptima® Combo 2 Assay should be interpreted in conjunction with other laboratory and clinical data available to the clinician. The Aptima® Combo 2 Assay is not intended for the evaluation of suspected sexual abuse or for other medico-legal indications. For a complete list of assay limitations we recommend that you review the manufacturers package insert, https://www.hologic.com/package-inserts/diagnostic-products/aptima-combo-2-assay-ctng IMPORTANT: Please review the Specimen Collection instructions SPECIMEN COLLECTION GUIDES FOR APTIMA for this test Transport Container Aptima® Transport Tube Transport Temperature Room temperature Specimen Stability Room temperature: 30 days Refrigerated: 30 days Frozen: 30 days Reject Criteria Transport tubes with 2 swabs • Transport tubes with non-Aptima® swabs • Swab transport tubes with no swab • Specimens in broken containers • Swab submitted in transport media Methodology Transcription-Mediated Amplification (TMA) Assay Category The analytical performance characteristics of this assay have been determined by Quest Diagnostics. The modifications have not been cleared or approved by the FDA. This assay has been validated pursuant to the CLIA regulations and is used for clinical purposes. Reference Range(s) C. trachomatis TMA, Throat Not detected N. gonorrhoeae TMA, Throat Not detected Alternative Name(s) CT/NG Aptima,CT/GC Aptima,CT/GC TMA,CT/NG TMA
"Clinical Significance Chlamydia/Neisseria Gonorrhoeae RNA, TMA, Urine - C. trachomatis infections are the leading cause of sexually transmitted diseases in the United States. C. trachomatis is known to cause cervicitis, pelvic inflammatory disease (PID), epididymitis and proctitis. It is also the most frequent cause of non-gonococcal urethritis in men. Among women, the consequences of chlamydial infections are severe if left untreated. Approximately half of chlamydial infections are asymptomatic. Neisseria gonorrhoeae (gonococci) is the causative agent of gonorrhea. In men, this disease generally results in anterior urethritis accompanied by purulent exudate. In women, the disease is most often found in the cervix, but the vagina and uterus may also be infected. Preferred Specimen(s) 2 mL random urine submitted in Aptima® transport tube Minimum Volume 2 mL Collection Instructions 2 mL of urine specimen must be transferred into the Aptima® specimen transport within 24 hours of collection. Use tube provided in the urine specimen collection kit for urine specimens. The fluid (urine plus transport media) level in the urine transport tube must fall within the clear pane on the tube label. Note: Results from the Aptima® Combo 2 assay should be interpreted in conjunction with other laboratory and clinical data available to the clinician. The Aptima® Combo 2 assay is not intended for the evaluation of suspected sexual abuse or for other medico-legal indications. For a complete list of assay limitations we recommend that you review the manufacturer's package insert, https://www.hologic.com/package-inserts/diagnostic-products/aptima-combo-2-assay-ctng Transport Container Aptima® Urine Collection kit Transport Temperature Room temperature Specimen Stability Room temperature: 30 days Refrigerated: 30 days Frozen: 1 year Includes Chlamydia trachomatis, RNA, TMA Neisseria gonorrhoeae, RNA, TMA Patient Preparation Patient should not have urinated within one hour prior to collection. Female patients should not cleanse the labial area prior to providing the specimen. Direct patient to provide a first-catch urine (a maximum of 20-30 mL of the initial urine stream) into a urine collection cup free of any preservatives. Methodology Target Capture Reference Range(s) C. trachomatis RNA, TMA Not detected N. gonorrhoeae RNA, TMA Not detected
"Clinical Significance Chlamydia/Neisseria gonorrhoeae RNA, TMA, Urogenital (REFL) - C. trachomatis infections are the leading cause of sexually transmitted diseases in the United States. C. trachomatis is known to cause cervicitis, pelvic inflammatory disease (PID), epididymitis and proctitis. It is also the most frequent cause of non-gonococcal urethritis in men. Among women, the consequences of Chlamydial infections are severe if left untreated. Approximately half of Chlamydial infections are asymptomatic. Neisseria gonorrhoeae (gonococci) is the causative agent of gonorrhea. In men, this disease generally results in anterior urethritis accompanied by purulent exudate. In women, the disease is most often found in the cervix, but the vagina and uterus may also be infected. Preferred Specimen(s) 1 vaginal swab in Aptima® Transport Tube or 1 endocervical or urethral swab in Aptima® Transport Tube or 2 mL urine in Aptima Transport Tube or 1 mL liquid cytology (PreservCyt®) Preservative (ThinPrep®) in Aptima® Transfer Tube or 0.5 mL SurePath™ Preservative Fluid in Aptima® Transfer Tube Minimum Volume 1 vaginal swab in Aptima® Transport • 1 endocervical or urethral swab in Aptima® Transport • 2 mL urine in Aptima® Transport • 1 mL PreservCyt® (ThinPrep®) in Aptima® Transfer Tube • 0.5 mL SurePath™ fluid in Aptima® Transfer Tube Collection Instructions Vaginal swab: Follow instructions in the Aptima® Vaginal Swab Collection or Multitest Collection Kit (orange label). Endocervical or urethral swab: Follow instructions in the Aptima® Unisex Swab Specimen Collection Kit (white label). In females, to ensure collection of cells infected with N. gonorrhoeae/C. trachomatis, columnar epithelial cells lining the endocervix should be obtained. Excess mucus should be removed prior to sampling. Urine: Direct patient to provide a first-catch urine (a maximum of 20-30 mL of the initial urine stream) into a urine collection cup free of any preservatives. 2 mL of urine specimen must be transferred into the Aptima® Specimen Transport within 24 hours of collection and before being assayed. Use the tube provided in the urine specimen collection kit. The fluid (urine plus transport media) level in the urine transport tube must fall within the clear pane of the tube label. Labs performing cytology: Aliquot PreservCyt® solution before performance of liquid based cytology testing. PreservCyt®: Transfer 1 mL PreservCyt® solution into Aptima® Specimen Transfer Tube (green label) or Aptima® Vaginal Collection or Multitest Collection Tube (orange label) or Unisex Swab Specimen Collection Kit (white label). SurePath™: SurePath™ fluid must be transferred to APTIMA® tube within 4 days of collection. Transfer 0.5 mL SurePath™ solution into Aptima® Specimen Transfer Tube (green label) or Aptima® Vaginal Collection or Multitest Collection Tube (orange label) or Unisex Swab Specimen Collection Kit (white label). Note: Results from the Aptima® Combo 2 Assay should be interpreted in conjunction with other laboratory and clinical data available to the clinician. The Aptima® Combo 2 Assay is not intended for the evaluation of suspected sexual abuse or for other medico-legal indications. For a complete list of assay limitations we recommend that you review the manufacturers package insert, https://www.hologic.com/package-inserts/diagnostic-products/aptima-combo-2-assay-ctng Transport Container Aptima® Transport Tube Transport Temperature Room temperature Specimen Stability Liquid cytology (Preservcyt® Preservative (ThinPrep®) Room temperature: 14 days Refrigerated: 30 days Frozen: 12 months SurePath™ Preservative Fluid Room temperature: 14 days Refrigerated: 14 days Frozen: Unacceptable Urine in Aptima® Transport Medium Room temperature: 30 days Refrigerated: 30 days Frozen: 12 months Swabs in Aptima® Transport Room temperature: 60 days Refrigerated: 60 days Frozen: 12 months Reject Criteria Transport tubes with 2 swabs • Transport tubes with Non-Aptima® swabs • Swab transport tubes with no swab • Specimens in broken containers • Swab submitted in viral transport media • Urine samples where the fluid level is not between the black fill lines • PreservCyt® material previously processed for cytology • PreservCyt® with excess mucus Includes This is a client specific reflex test. Reflex criteria has been pre-defined by the ordering physician. Additional testing will be performed at an additional charge. Chlamydia trachomatis RNA, TMA, Urogenital Neisseria gonorrhoeae RNA, TMA, Urogenital Patient Preparation Urine: Patient should not have urinated within one hour prior to collection. Female patients should not cleanse the labial area prior to providing the specimen. Methodology Transcription-Mediated Amplification (TMA) Reference Range(s) C. trachomatis RNA, TMA, Urogenital Not detected N. gonorrhoeae RNA, TMA, Urogenital Not detected
"Clinical Significance Chlamydia/Neisseria gonorrhoeae RNA, TMA with Reflex to Alternate Target, Urogenital - To screen for the infection with Neisseria gonorrhoeae and Chlamydia trachomatis in vaginal, endocervical and urethral swabs or urine from men and women. Preferred Specimen(s) 1 vaginal swab in APTIMA® Transport Tube or 1 endocervical or urethral swab in APTIMA® Transport Tube or 2 mL urine in APTIMA® Transport Tube or 1 mL liquid cytology (PreservCyt®) preservative (ThinPrep®) in APTIMA® Transfer Tube or 0.5 mL SurePath™ preservative fluid in APTIMA® Transfer Tube Minimum Volume 1 vaginal swab in APTIMA® Transport • 1 endocervical or urethral swab in APTIMA® Transport • 2 mL urine in APTIMA® Transport • 1 mL PreservCyt® (ThinPrep®) in APTIMA® Transfer Tube • 0.5 mL SurePath™ fluid in APTIMA® Transfer Tube IMPORTANT: Please review the Specimen Collection instructions SPECIMEN COLLECTION GUIDES FOR APTIMA for this test Specimen Stability Liquid cytology (Preservcyt®) Preservative (ThinPrep®) Room temperature: 14 days Refrigerated: 30 days Frozen: 12 months SurePath™ Preservative Fluid Room temperature: 14 days Refrigerated: 14 days Frozen: Unacceptable Urine in APTIMA® Transport Medium Room temperature: 30 days Refrigerated: 30 days Frozen: 12 months Swabs in APTIMA® Transport Room temperature: 60 days Refrigerated: 60 days Frozen: 12 months Includes Chlamydia trachomatis RNA, TMA, Urogenital Neisseria gonorrhoeae RNA, TMA, Urogenital If either Chlamydia trachomatis RNA, TMA, Urogenital or Neisseria gonorrhoeae RNA, TMA, Urogenital are Detected, then Chlamydia trachomatis, TMA (Alternate Target), Urogenital or Neisseria gonorrhoeae, TMA (Alternate Target), Urogenital will be performed at an additional charge (CPT code(s): 87491 or 87591) Patient Preparation Urine: Patient should not have urinated within one hour prior to collection. Female patients should not cleanse the labial area prior to providing the specimen. Methodology Transcription-Mediated Amplification (TMA) Reference Range(s) C. trachomatis RNA, TMA, Urogenital Not detected N. gonorrhoeae RNA, TMA, Urogenital Not detected
CHLORIDE TEST What are the other names for this test? Chloride blood test, Cl test, Serum Chloride, Chloride urine test, Urinary Chloride test What is a chloride test? A chloride blood test helps to determine chloride levels in your blood. Chloride is a form of electrolyte. Electrolytes are electrically charged minerals that maintain fluid amount and acid-base balance (pH balance). Chloride is often present in table salt as an ingredient. It is a significant mineral that helps your body to balance fluid levels in your blood cells. Abnormal chloride levels may lead to various health problems. The chloride deficiency happens due to diarrhea or vomiting. This test is often conducted with other electrolytes to monitor and diagnose health conditions, including heart problems, liver disease, kidney disease, and high blood pressure. What is the purpose of this test? A chloride blood test helps to see abnormal chloride levels in your blood. This test is a routine test often included in an electrolyte panel. A chloride blood or urine test may help your provider if you experience problems in the kidneys, lungs, liver, and other system parts that involve maintaining the acid-base levels in your body. A chloride test may use to: Determine the reason for acid-base disorders. This condition may indicate another health problem that leads to an acid-base imbalance in your body. Monitor the chloride levels if you are already taking treatment for acid-base imbalance and their root cause, which raises them. The acid-base balance control by your lungs, kidneys, and chemical body processes, leads to small pH changes. You may have acid-base problems if your body does not adjust to these pH changes. Electrolyte tests, like the chloride test, help to see your body’s response required to control acid-base balance. When do I need to take this test? Your healthcare provider may order a chloride blood test if you see symptoms of an acid-base base or fluid imbalance in your body. Symptoms of acid-base imbalances include: Fatigue Nausea Vomiting for a long time Weakness Dehydration Difficulty in breath Your healthcare provider uses this test to see your kidney conditions or other health problems. When you have abnormal chloride levels, you should place a chloride test to identify the hidden health problems. What is the procedure for this test? A chloride test is a blood test that often needs your blood sample. The following are the steps for this test after visiting the laboratory. Sit in front of your provider. Be relaxed and stay in a fixed position. It is difficult for your provider to collect a blood sample if you do the muscle movement. Remove the portion of your cloth from the arm. A small needle will inject into a vein in your arm. A small amount of blood will collect in a test tube. Blood samples will store in the laboratory for examination of an allergy. You can go home for regular activities. This test usually takes five minutes. You may also need a urine sample for a chloride test. Your provider may recommend a 24-hour urine or random urine test. For a 24-hour urine test, the steps include Starting urine in a toilet in the morning without collecting it. Note the time of urinating Put your urine in the container for the next 24 hours Store that urine in a refrigerator or at a cool place Give your container with urine to the lab care as per the guidelines For a random or spot urine sample, your healthcare provider will instruct you to collect all urine at any time. How do I need to prepare for this test? You can inform your provider about medicines, vitamins, and supplements you use. Your provider will guide you on when to stop medication for a few days before the test. You do not need preparation if your provider asks for a urine chloride test. Are there any risks involved in this test? A chloride test has low risks when you give a blood sample. Vein differs from person to person. Some people or children may have difficulty providing a blood sample compared to others. You may experience low risks when the needle injects into your vein include Infection Bruising Extreme Bleeding Slight pain Hematoma (Deposition of blood under the skin) What do the test results indicate? The chloride test results depend on many factors, such as age, gender, and medical history. The test results may also slightly differ among laboratories. It is because each lab may use different methods for examination. The reference range for chloride in adults is about 96 to 106 milliequivalents per liter (mEq/L). The recommended range for chloride in children and newborns is 95 to 108 mEq/L and 96 to 113 mEq/L, respectively. Discuss here with professional healthcare about what your test results mean. High chloride levels in the blood, known as hypochloremia, may develop due to the following reasons: Lung disease Heart failure Vomiting Metabolic alkalosis - a condition of a high base in your blood. This results in muscle cramps, tingling in the fingers and toes, and irritability. Addison disease - a condition in which your adrenal glands do not develop specific hormones, may lead to these symptoms, such as weight loss, dehydration, weakness, and dizziness. Respiratory acidosis - a condition in which breathing disturbance leads to high acidity in the body. Excess sweating High chloride levels in the blood, known as hyperchloremia, may occur due to the following reasons: Kidney disease Dehydration - losing high water amounts from the body Metabolic acidosis - A condition of excess acid in your blood that may lead to fatigue, nausea, and vomiting. Intake of specific medicines Respiratory alkalosis - a condition that involves increased breathing and high alkalinity in the blood. Renal tubular acidosis - a condition in which your kidneys lose the ability to eliminate enough acid from your blood. High chloride levels in urine may occur due to the following conditions A high amount of salt intake in the diet Losing potassium Kidney inflammation Adrenal glands disorder Polyuria - a condition that leads to high urine development. Low chloride levels in urine may occur due to the following conditions Less amount of salt intake in the diet Cushing’s syndrome - a condition in which your body produces a high cortisol hormone amount Fluid loss due to diarrhea, sweating, or vomiting What factors may affect the test results? If your chloride test shows abnormal results, this does not always indicate a medical problem. Test results may change with the amount of fluid intake or loss. You experience low chloride levels when vomiting or losing fluid due to diarrhea. Some drinks that include caffeine may lead to losing water and affect your chloride levels. Specific medicines, like antacids, may also alter your test results. What additional tests do I need along with this test? Your healthcare provider may ask for other tests to measure other electrolytes in your blood, such as sodium and potassium. You may also need to order a urine test for chloride to observe your chloride levels and your blood for blood sugar levels. A basic urinalysis macroscopic test may also perform to discover problems in your kidneys or urinary tract. Creatinine and blood urea nitrogen are tests that may also define the conditions of your kidneys.
"Clinical Significance Cholesterol, Total (REFL) - Total LDL and HDL cholesterol, in conjunction with a triglyceride determination, provide valuable information for the risk of coronary artery disease. Total serum cholesterol analysis is useful in the diagnosis of hyperlipoproteinemia, atherosclerosis, hepatic and thyroid diseases. Preferred Specimen(s) 1 mL serum Alternative Specimen(s) Sodium heparin (green-top) tube • Lithium heparin (green-top) tube Minimum Volume 0.5 mL Transport Container Serum separator tube (SST) Transport Temperature Room temperature Specimen Stability Serum Room temperature: 7 days Refrigerated: 7 days Frozen: 90 days Plasma Room temperature: 48 hours Refrigerated: 48 hours Frozen: 6 months Reject Criteria Gross hemolysis • Anticoagulants other than heparin • Moderate to gross icterus Includes This is a client specific reflex test. Reflex criteria has been pre-defined by the ordering physician. Additional testing will be performed at an additional charge. Patient Preparation If a cholesterol measurement is to be performed along with triglycerides, but not part of a lipid panel, then the patient should be fasting 9-12 hours prior to collection. If the cholesterol is ordered as part of a lipid panel, then a fasting sample is not required. The assay manufacturer Beckman Coulter advises: "N-Acetyl Cysteine (NAC), when administered in therapeutic concentrations (for the treatment of acetaminophen overdose), has been...determined to interfere with assays for...cholesterol, uric acid" where "NAC interference may lead to falsely low results." According to Beckman Coulter, the NAC interference should be insignificant by 12 hours after completion of the initial loading dose of an IV infusion treatment regimen consisting of an initial loading dose of 150 mg/kg administered over 1 hour, a second dose of 50 mg/kg administered over 4 hours and a third dose of 100 mg/kg administered over 16 hours. Methodology Spectrophotometry (SP) Reference Range(s) <20 Years <170 mg/dL ≥20 Years <200 mg/dL
"Clinical Significance Cholesterol, Total (REFL) - Total LDL and HDL cholesterol, in conjunction with a triglyceride determination, provide valuable information for the risk of coronary artery disease. Total serum cholesterol analysis is useful in the diagnosis of hyperlipoproteinemia, atherosclerosis, hepatic and thyroid diseases. Preferred Specimen(s) 1 mL serum Alternative Specimen(s) Sodium heparin (green-top) tube • Lithium heparin (green-top) tube Minimum Volume 0.5 mL Transport Container Serum separator tube (SST) Transport Temperature Room temperature Specimen Stability Serum Room temperature: 7 days Refrigerated: 7 days Frozen: 90 days Plasma Room temperature: 48 hours Refrigerated: 48 hours Frozen: 6 months Reject Criteria Gross hemolysis • Anticoagulants other than heparin • Moderate to gross icterus Includes This is a client specific reflex test. Reflex criteria has been pre-defined by the ordering physician. Additional testing will be performed at an additional charge. Patient Preparation If a cholesterol measurement is to be performed along with triglycerides, but not part of a lipid panel, then the patient should be fasting 9-12 hours prior to collection. If the cholesterol is ordered as part of a lipid panel, then a fasting sample is not required. The assay manufacturer Beckman Coulter advises: "N-Acetyl Cysteine (NAC), when administered in therapeutic concentrations (for the treatment of acetaminophen overdose), has been...determined to interfere with assays for...cholesterol, uric acid" where "NAC interference may lead to falsely low results." According to Beckman Coulter, the NAC interference should be insignificant by 12 hours after completion of the initial loading dose of an IV infusion treatment regimen consisting of an initial loading dose of 150 mg/kg administered over 1 hour, a second dose of 50 mg/kg administered over 4 hours and a third dose of 100 mg/kg administered over 16 hours. Methodology Spectrophotometry (SP) Reference Range(s) <20 Years <170 mg/dL ≥20 Years <200 mg/dL
Clinical Significance Cladosporium herbarum (m2) IgE - This allergen-specific IgE antibody test quantifies an individual’s IgE response to Cladosporium herbarum. It is an in vitro quantitative assay that is intended to be used in conjunction with other clinical information to aid in the diagnosis of allergic diseases [1]. While allergen-specific serum IgE testing is considered comparable to skin testing in many instances, both the American Academy of Allergy, Asthma, and Immunology and the American College of Allergy, Asthma, and Immunology recognize that allergen-specific serum IgE testing may be preferred in some clinical situations. These include 1) the presence of widespread skin disease, 2) the recent use of antihistamines or other medications that can affect the results of allergy skin tests, 3) uncooperative patients, and 4) medical history suggesting that allergen skin testing would pose a significant risk for a serious allergic reaction [1]. A definitive clinical diagnosis of allergy should not be based on the results of any single diagnostic method, but should be made by a trained healthcare provider after all clinical and laboratory findings have been evaluated. Preferred Specimen(s) 0.3 mL serum Minimum Volume 0.15 mL/allergen Transport Container Serum Separator Tube (SST®) Transport Temperature Room temperature Specimen Stability Room temperature: 14 days Refrigerated: 14 days Frozen: 30 days
Preferred Specimen(s) 0.3 mL serum Transport Container Serum Separator Tube (SST®) Transport Temperature Room temperature Specimen Stability Room temperature: 14 days Refrigerated: 14 days Frozen: 30 days Methodology Immunoassay - Analyte Specific Reagents Assay Category This test was developed and its analytical performance characteristics have been determined by Quest Diagnostics. It has not been cleared or approved by FDA. This assay has been validated pursuant to the CLIA regulations and is used for clinical purposes. Alternative Name(s) ImmunoCAP®