Sexually-transmitted infections (STIs) constitute a major health burden in the U.S., and reported incidence among adolescents is increasing. These diseases are frequently asymptomatic and are most often caused by viruses or bacteria.
| Test Name and Number | Recommended Use | Limitations | Follow Up |
|---|---|---|---|
| Sexually Transmitted Disease Panel 1 2006258 Method: Qualitative Target Amplification Nucleic Acid Probe |
Preferred test for detecting C. trachomatis, N .gonorrhoeae, and T. vaginalis in variety of specimens Refer to Sample Collection for the Diagnosis of STD Using Nucleic Acid Amplification Tests for optimal specimen types and collection instructions Highly sensitive and specific |
Testing of oral and rectal specimens is not recommended |
|
| Chlamydia trachomatis and Neisseria gonorrhoeae by Transcription-Mediated Amplification (TMA) 0060241 Method: Qualitative Target Amplification Nucleic Acid Probe |
Preferred test for detecting C. trachomatis and N. gonorrhoeae in variety of specimens Positive results are confirmed using an alternative nucleic acid target in according with CDC guidelines Refer to Sample Collection for the Diagnosis of STD Using Nucleic Acid Amplification Tests for optimal specimen types and collection instructions Highly sensitive and specific |
Culture may be required in certain clinical contexts for diagnosing C. trachomatis and N. gonorrhoeae infections to meet applicable laws and regulations |
|
| Chlamydia trachomatis and Neisseria gonorrhoeae by Transcription-Mediated Amplification (TMA), M4/UTM 0060774 Method: Qualitative Target Amplification Nucleic Acid Probe |
Viral transport media (eg, M4/UTM) are not preferred for C. trachomatis and N. gonorrhoeae by Amplified Detection (APTIMA) Refer to Sample Collection for the Diagnosis of STD Using Nucleic Acid Amplification Tests for optimal specimen types and collection instructions |
Specimen collection and transportation can affect sensitivity; use of transport media other than the manufacturer's collection kit may result in reduced sensitivity Culture may be required in certain clinical contexts for diagnosing C. trachomatis and N. gonorrhoeae infections to meet applicable laws and regulations |
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| Chlamydia trachomatis and Neisseria gonorrhoeae by Transcription-Mediated Amplification (TMA), ThinPrep 0060734 Method: Qualitative Target Amplification Nucleic Acid Probe |
Can be used to detect C. trachomatis and N. gonorrhoeae in ThinPrep specimens For optimal sensitivity, vaginal swabs are recommended Positive results are confirmed using an alternative nucleic acid target in according with CDC guidelines Refer to Sample Collection for the Diagnosis of STD Using Nucleic Acid Amplification Tests for optimal specimen types and collection instructions |
Culture may be required in certain clinical contexts for diagnosing C. trachomatis and N. gonorrhoeae infections to meet applicable laws and regulations | |
| Chlamydia trachomatis and Neisseria gonorrhoeae by Transcription-Mediated Amplification (TMA), SurePath 2001551 Method: Qualitative Target Amplification Nucleic Acid Probe |
Can be used to detect C. trachomatis and N. gonorrhoeae in SurePath specimens For optimal sensitivity, vaginal swabs collected and transported using the manufacturers’ collection kits are recommended Positive results are confirmed using an alternative nucleic acid target in accordance with CDC guidelines Refer to Sample Collection for the Diagnosis of STD Using Nucleic Acid Amplification Tests for optimal specimen types and collection instructions |
Use of transport media other than the manufacturer's collection kit may result in reduced sensitivity Culture may be required in certain clinical contexts for diagnosing C. trachomatis and N. gonorrhoeae infections to meet applicable laws and regulations Test not recommended for patients <13 years |
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| Trichomonas vaginalis by Transcription-Mediated Amplification (TMA) 2005506 Method: Qualitative Target Amplification Nucleic Acid Probe |
Diagnose infection with T. vaginalis from genitourinary sources Refer to Sample Collection for the Diagnosis of STD Using Nucleic Acid Amplification Tests for optimal specimen types and collection instructions |
Performance of test on self-collected vaginal swab specimens and those from pregnant women has not been evaluated |
|
| Chlamydia trachomatis by Transcription-Mediated Amplification (TMA) 0060243 Method: Qualitative Target Amplification Nucleic Acid Probe |
Use to detect C. trachomatis; in individuals at risk for N. gonorrhoeae, preferred test is one of the combined nucleic acid amplification tests (NAAT) Highly sensitive and specific Positive results are confirmed using an alternative nucleic acid target in according with CDC guidelines Refer to Sample Collection for the Diagnosis of STD Using Nucleic Acid Amplification Tests for optimal specimen types and collection instructions |
Culture may be required in certain clinical contexts for diagnosing C. trachomatis and N. gonorrhoeae infections to meet applicable laws and regulations | |
| Neisseria gonorrhoeae by Transcription-Mediated Amplification (TMA) 0060244 Method: Qualitative Target Amplification Nucleic Acid Probe |
Use to detect N. gonorrhoeae Preferred test is one of the combined nucleic acid amplification tests (NAAT) Highly sensitive and specific Positive results are confirmed using an alternative nucleic acid target in according with CDC guidelines Refer to Sample Collection for the Diagnosis of STD Using Nucleic Acid Amplification Tests for optimal specimen types and collection instructions |
Culture may be required in certain clinical contexts for diagnosing C. trachomatis and N. gonorrhoeae infections to meet applicable laws and regulations or for use in suspected failure of therapy | |
| Chlamydia trachomatis DFA 0060287 Method: Direct Fluorescent Antibody Stain |
Not recommended for detecting C. trachomatis Preferred test is one of the nucleic acid amplification tests (NAAT) Diagnose infection with C. trachomatis |
Relatively low sensitivity compared to NAAT Sensitivity of this method is dependent on adequacy of smear |
|
| Chlamydia trachomatis Culture 0060850 Method: Cell Culture/Immunofluorescence |
Not recommended for routine detection of C. trachomatis Use to detect C. trachomatis in medicolegal settings and to assess suspected treatment failure May be considered for anatomic locations for which amplified testing has not been validated High specificity Diagnose infection with C. trachomatis Culture should be ordered in cases of suspected sexual abuse or suspected failure of therapy Historically the gold standard for diagnosis |
Less sensitive than nucleic acid amplification tests Two to three days required for results Amplified DNA testing is recommended for detection of C. trachomatis from endocervical or urethral specimens; refer to C. trachomatis by Amplified Detection (APTIMA®) Culture may be required in certain clinical contexts for diagnosing C. trachomatis and N. gonorrhoeae infections to meet applicable laws and regulations |
|
| Gonorrhea Culture 0060110 Method: Culture/Identification |
May be used to detect N. gonorrhoeae, especially if NAAT has not been validated for a particular specimen type Preferred test to diagnose N. gonorrhoeae is one of the combined nucleic acid amplification tests (NAAT) |
Sensitivity is dependent on transport time; N. gonorrhoeae is fastidious, and viability declines rapidly during transport |