← Product Code [MKZ](/submissions/MI/subpart-d%E2%80%94serological-reagents/MKZ) · K080739

# ABBOTT REALTIME CT/NG ASSAY AND MULTI-COLLECT SPECIMEN COLLECTION KIT (K080739)

_Abbott Molecular, Inc. · MKZ · Jul 10, 2008 · Microbiology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/MKZ/K080739

## Device Facts

- **Applicant:** Abbott Molecular, Inc.
- **Product Code:** [MKZ](/submissions/MI/subpart-d%E2%80%94serological-reagents/MKZ.md)
- **Decision Date:** Jul 10, 2008
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 866.3120
- **Device Class:** Class 1
- **Review Panel:** Microbiology

## Indications for Use

The Abbott RealTime CT/NG assay is an in vitro polymerase chain reaction (PCR) assay for the direct, qualitative detection of the plasmid DNA of Chlamydia trachomatis and the genomic DNA of Neisseria gonorrhoeae. The assay may be used to test the following specimens from symptomatic individuals: clinician-collected vaginal swab and male urethral swab specimens; patient-collected vaginal swab specimens; and female and male urine specimens. The assay may be used to test the following specimens from asymptomatic individuals: male and female urine. The Abbott multi-Collect Specimen Collection Kit is intended for the collection and transportation of male and female swab and urine specimens for the detection of Chlamydia trachomatis and Neisseria gonorrheae per instructions provided. Self-collected vaginal swab specimens are an option for screening women when a pelvic exam is not otherwise indicated. The Abbott multi-Collect Specimen Collection Kit is not intended for home use.

## Device Story

Abbott RealTime CT/NG is an in vitro PCR assay for qualitative detection of Chlamydia trachomatis (plasmid DNA) and Neisseria gonorrhoeae (genomic DNA). The Abbott multi-Collect Specimen Collection Kit stabilizes DNA in swab or urine samples using guanidine thiocyanate buffer. Samples are processed on the m2000 System (m2000sp for sample prep, m2000rt for amplification/detection). The system uses real-time fluorescence detection to identify target sequences. Used in clinical settings by healthcare professionals; not for home use. Results assist clinicians in diagnosing chlamydial and gonococcal infections, facilitating appropriate treatment and partner notification. Benefits include high sensitivity/specificity compared to culture, aiding in management of asymptomatic and symptomatic patients.

## Clinical Evidence

Multi-center clinical study (n=3,832) across 16 US sites (private practice, STD clinics, ER). Compared Abbott RealTime CT/NG against reference NAATs and NG culture. Primary endpoints: sensitivity and specificity. For CT, sensitivity ranged 92.5-97.8% and specificity 98.3-99.7% across specimen types. For NG, sensitivity ranged 87.0-100% and specificity 99.6-100%. Study included symptomatic and asymptomatic populations.

## Technological Characteristics

Uses real-time PCR amplification and fluorescence detection on the Abbott m2000 System. Specimen collection kit uses guanidine thiocyanate buffer for DNA stabilization. Automated sample preparation and amplification. Qualitative assay.

## Regulatory Identification

Chlamydia serological reagents are devices that consist of antigens and antisera used in serological tests to identify antibodies to chlamydia in serum. Additionally, some of these reagents consist of chlamydia antisera conjugated with a fluorescent dye used to identify chlamydia directly from clinical specimens or cultured isolates derived from clinical specimens. The identification aids in the diagnosis of disease caused by bacteria belonging to the genus Chlamydia and provides epidemiological information on these diseases. Chlamydia are the causative agents of psittacosis (a form of pneumonia), lymphogranuloma venereum (a venereal disease), and trachoma (a chronic disease of the eye and eyelid).

## Predicate Devices

- GEN-PROBE® APTIMA® Combo 2 Assay ([K043224](/device/K043224.md))
- Becton Dickenson ProbeTec™ ET Chlamydia trachomatis /Neisseria gonorrhoeae Amplified DNA Assay ([K012351](/device/K012351.md))
- Gen-Probe® APTIMA™ Unisex Swab Specimen Collection Kit ([K043224](/device/K043224.md))
- Gen-Probe APTIMA Urine Specimen Collection Kit ([K043144](/device/K043144.md))
- Gen-Probe APTIMA Vaginal Swab Specimen Collection Kit ([K032554](/device/K032554.md))
- BD ProbeTec ET Urine Processing Kit ([K052224](/device/K052224.md))

## Submission Summary (Full Text)

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>
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510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION
DECISION SUMMARY

A. 510(k) Number:
K080739

B. Purpose for Submission:
New device

C. Analyte:
Chlamydia trachomatis
Neisseria gonorrhoeae
Type of Test:
Nucleic Acid Amplification
Applicant:
Abbott Molecular Inc.
Proprietary and Established Names:
Abbott RealTime CT/NG

D. Regulatory Information:
1. Regulation section:
866.3120
866.3390
2. Classification:
I, II
3. Product Code:
MKZ, LSL
4. Panel:
Microbiology 083

Intended Use:
5. Intended use(s):
The Abbott RealTime CT/NG assay is an in vitro polymerase chain reaction (PCR) assay for the direct, qualitative detection of the plasmid DNA of Chlamydia trachomatis and the genomic DNA of Neisseria gonorrhoeae. The assay may be used to test the following specimens from symptomatic individuals: clinician-collected vaginal swab and male urethral swab specimens; patient-collected vaginal swab specimens; and female and male urine specimens. The assay may be used to test the following specimens from asymptomatic individuals: male and female urine.
6. Indication(s) for use:
Same as intended use
7. Special condition for use statement(s):
NA

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8. Special instrument Requirements:
Abbott m2000 System

Device Description:
Abbott RealTime CT/NG consists of two reagent kits:
- Abbott RealTime CT/NG Amplification Reagent Kit (List No. 8L07-90)
- Abbott RealTime CT/NG Control Kit (List No. 8L07-80)
The Abbott RealTime CT/NG assay uses PCR technology with homogenous real-time fluorescence detection on the m2000 System. The Abbott m2000 System consists of the Abbott m2000sp and Abbott m2000rt instruments. The Abbott m2000 System integrates sample preparation with nucleic acid amplification and detection to generate assay results. The Abbott m2000sp is used for processing samples and the Abbott m2000rt is used for amplification and detection.

The Abbott multi-Collect Specimen Collection Kit can be used to collect either a swab or a urine specimen. Each Abbott multi-Collect Specimen Collection Kit (List No. 9K12) contains:
- One Transport Tube containing 1.2 mL Specimen Transport Buffer
- One Individually Packaged Sterile Specimen Collection Swab (Part No. CD650)
- One disposable transfer pipette.
The Specimen Transport Buffer consists of guanidine thiocyanate, a chaotropic salt, in Tris buffer and is used to stabilize DNA until sample preparation. The individually packaged sterile Specimen Collection Swab is used for swab sample collection and placed directly into the Transport Tube. The transfer pipette is used to add approximately 3 mL of urine to the Transport Tube. The Abbott multi-Collect Specimen Collection Kit is for single use only.

E. Substantial Equivalence Information:

1. Predicate device name(s):
GEN-PROBE® APTIMA® Combo 2 Assay (Assigned 510(k) No. K043224);
Becton Dickenson ProbeTec™ ET Chlamydia trachomatis /Neisseria gonorrhoeae Amplified DNA Assay (Assigned 510(k) No. K012351);
Gen-Probe® APTIMA™ Unisex Swab Specimen Collection Kit for Endocervical and Urethral Swab Specimens (K043224);
Gen-Probe APTIMA Urine Specimen Collection Kit for Male and Female Urine (Assigned 510(k) No. K043144);
Gen-Probe APTIMA Vaginal Swab Specimen Collection Kit (Assigned 510(k) No. K032554);
BD ProbeTec ET Urine Processing Kit Assigned 510(k) No. (K052224).

2. Predicate K number(s):
K043224, K012351, K043224, K043144, K032554, K052224

3. Comparison with predicate:

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|  Feature | Current Application
Abbott RealTime CT/NG | Amplified Nucleic Acid Predicate Devices
Gen-Probe Aptima Combo 2 | Becton Dickenson ProbeTec ET  |
| --- | --- | --- | --- |
|  Assay Type | • Qualitative | • Qualitative | • Qualitative  |
|  CT Analyte Targets | • CT cryptic plasmid DNA | • CT ribosomal RNA | • CT cryptic plasmid DNA  |
|  NG Analyte Targets | • NG genomic DNA | • NG ribosomal RNA | • NG genomic DNA  |
|  Input Sample Types | • Self-collected vaginal swab specimens
• Clinician-collected vaginal swab specimens
• Male urethral swab specimens
• Male and female urine specimens | • Endocervical swab specimens
• Self-collected vaginal swab specimens
• Clinician-collected vaginal swab specimens
• Male urethral swab specimens
• Male and female urine specimens
• PreservCyt liquid Pap specimens | • Endocervical swab specimens
• Male urethral swab specimens
• Male and female urine specimens  |
|  Sample Preparation Procedure | • Automated | • Semi-automated/automated | • Manual/ semi-automated  |
|  Amplification Technology | • Real-time PCR | • TMA | • SDA  |
|  Assay Controls | • Negative Control
• Cutoff Control
• Internal Control | • Negative Control
• Positive Control | • Negative Control
• Positive Control
• Optional Amplification Control  |
|  Feature | Current Application
Abbott multi-Collect Specimen Collection Kit | Predicate Devices for Urine Specimens
Gen-Probe Aptima Urine Specimen Collection Kit | BDProbeTec Urine Processing Kit  |
| --- | --- | --- | --- |
|  Device Description | Contains a transfer pipette for adding approximately 3.0 mL of urine to the Transport Tube. The Transport Tube contains 1.2 mL of Specimen Transport Buffer and is used to stabilize DNA until sample preparation. | Contains a disposable transfer pipette for adding approximately 2 mL of urine to a Specimen Transport Tube containing 2.0 mL of Transport Buffer. | Contains a disposable transfer pipette for adding approximately 2.5 to 3.5 mL of urine to one Urine Preservative Transport or Urine Processing Pouch.  |
|  Feature | Current Application
Abbott multi-Collect Specimen Collection Kit | Predicate Device for Male Urethral Swab Specimens
Gen-Probe Aptima Unisex Swab Specimen Collection Kit for Endocervical and Male Urethral Swab Specimens  |
| --- | --- | --- |
|  Device Description | Contains an individually packaged sterile Specimen Collection Swab that is placed into the Transport Tube after swab sampling. The Transport Tube contains 1.2 mL of Specimen Transport Buffer and is used to stabilize DNA until sample preparation. | Contains an individually packaged sterile Endocervical Cleaning Swab and an individually packaged sterile Specimen Collection Swab that is placed into the Transport Tube after swab sampling. The Transport Tube contains 2.9 mL of Specimen Transport Buffer and is used to stabilize DNA until sample preparation. The Gen-Probe Aptima Unisex Swab Specimen Collection Kit can be used to collect either Endocervical or Male Urethral Swab specimens.  |

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|  Feature | Current Application
Abbott multi-Collect Specimen Collection Kit | Predicate Device for Vaginal Swab Specimens
Gen-Probe Aptima Vaginal Swab Specimen Collection Kit  |
| --- | --- | --- |
|  Device Description | The Abbott multi-Collect Specimen Collection Kit contains a transfer pipette for adding approximately 3.0 mL of urine to the Transport Tube and an individually packaged sterile Specimen Collection Swab that is placed into the Transport Tube after swab sampling. The Transport Tube contains 1.2 mL of Specimen Transport Buffer and is used to stabilize DNA until sample preparation. The Abbott multi-Collect Specimen Collection Kit can be used to collect either a swab or a urine specimen. | The Gen-Probe Aptima Vaginal Swab Specimen Collection Kit contains an individually packaged sterile Specimen Collection Swab that is placed into the Transport Tube after swab sampling. The Transport Tube contains 2.9 mL of Specimen Transport Buffer and is used to stabilize DNA until sample preparation. The Gen-Probe Aptima Vaginal Swab Specimen Collection Kit is used to collect Vaginal Swab Specimens.  |

Standard/Guidance Document Referenced (if applicable): NA

Test Principle: See H. Device Description

## F. Performance Characteristics (if/when applicable):

### 1. Analytical performance:

#### Analytical Sensitivity

The analytical sensitivity of the Abbott RealTime CT/NG assay was determined by testing dilutions of *Chlamydia trachomatis* (CT) target DNA and *Neisseria gonorrhoeae* (NG) target DNA. Testing was performed with three lots of amplification reagents on three *m*2000 Systems. Probit analysis of the data determined that the concentration of CT DNA detected with 95% probability was 39 copies/assay (95% CI 33 - 51), and the concentration of NG DNA detected with 95% probability was 192 copies/assay (95% CI 176-220).

The limit of detection (LoD) claim for the RealTime CT/NG assay is 320 copies of CT target DNA and 320 copies of NG target DNA per assay. The limit of detection (LoD) is defined as the CT and NG DNA concentration detected with a probability of 95% or greater.

The CT/NG assay targets the *Chlamydia* cryptic plasmid (present at approximately 7 to 10 copies per *Chlamydia* organism) and the multicopy opacity gene of *Neisseria gonorrhoeae* (repeated up to 11 times per organism). Thus, 320 copies of target DNA translates to approximately 30 to 40 organisms per assay.

The claimed LOD for the Abbott RealTime CT/NG assay was confirmed by testing a ample containing 320 copies of CT target DNA and 320 copies of NG target DNA per assay. The detection rate was 100% (403/403) for both CT and NG in the assay. A study was conducted to challenge the performance of the Abbott RealTime CT/NG assay in samples containing high target numbers of either CT or NG in the presence of low target numbers of the opposite analyte. The detection rate of 320 copies of CT DNA in the presence of high NG target was 100% (400/400). The detection rate of 320 copies of NG DNA in the presence of high CT target was 98.5% (398/404).

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The analytical sensitivity of the Abbott RealTime CT/NG assay for detecting *Chlamydia trachomatis* serovars A through L was determined by testing dilutions of each serovar. Serovars A through K, L1, and L2 were detected at less than 1 Inclusion Forming Units (IFU) per assay and serovar L3 was detected at less than 3 IFU/assay. The analytical sensitivity of the Abbott RealTime CT/NG assay for detecting 28 different isolates of *Neisseria gonorrhoeae* was determined by testing dilutions of each isolate. All isolates were detected at less than 1 Colony Forming Unit (CFU)/assay.

## Evaluation of Potential Cross-Reactants

A total of 111 strains of bacteria, viruses, parasites, yeast, and fungi were tested for potential cross reactivity in the Abbott RealTime CT/NG assay (table below). These included organisms that are phylogenetically related to CT and NG, and those that can be found in the urogenital tract. Purified DNA or RNA was diluted to a final concentration of $1 \times 10^{7}$ copies/assay. HBV DNA and HCV RNA were added directly into the PCR reaction at approximately $3 \times 10^{5}$ and $9 \times 10^{6}$ copies per reaction, respectively. All results were negative for both CT and NG.

A total of 32 culture isolates were tested for potential cross reactivity in the Abbott RealTime assay. These included 27 organisms listed in table below, and *Neisseria cinerea*, *Neisseria lactamica*, *Neisseria sicca*, Ca Ski cells containing HPV 16, and Hela cells containing HPV 18. Ca Ski cells containing HPV 16 and Hela cells containing HPV 18 were tested at $10^{5}$ cells per assay, *C. pneumoniae* and *C. psittaci* were tested at $10^{6}$ EB per assay, HSV-1 and HSV-2 were tested at $10^{6}$ genomes per assay, and the rest of the organisms were tested at $10^{6}$ Colony Forming Units (CFU) per assay. All results were negative for both CT and NG.

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|  Microorganism/Virus  |   |   |
| --- | --- | --- |
|  Achromobacter xerosis | Haemophilus ducreyi* | Proteus vulgaris  |
|  Acinetobacter calcoaceticus | Haemophilus influenzae | Providencia stuartii  |
|  Acinetobacter lwoffii | Helicobacter pylori | Pseudomonas aeruginosa*  |
|  Actinomyces israelii | Hepatitis B virus (HBV) | Pseudomonas putida  |
|  Aerococcus viridans | Hepatitis C virus (HCV) | Rahnella aquatilis  |
|  Aeromonas hydrophila | Herpes Simplex Virus, type I* | Rhizobium radiobacter  |
|  Alcaligenes faecalis | Herpes Simplex Virus, type II* | Rhodospirillum rubrum  |
|  Arcanobacterium pyogenes | Human immunodeficiency virus (HIV-1) | Ruminococcus productus  |
|  Bacillus subtilis | Human Papilloma Virus 16 | Salmonella choleraesuis  |
|  Bacteroides fragilis | Human Papilloma Virus 18 | Salmonella typhimurium  |
|  Bacteroides urealyticus | Kingella denitrificans | Serratia marcescens*  |
|  Bifidobacterium adolescentis | Kingella kingae | Staphylococcus aureus*  |
|  Bifidobacterium breve | Klebsiella oxytoca | Staphylococcus epidermidis*  |
|  Brevibacterium linens | Klebsiella pneumoniae | Staphylococcus saprophyticus*  |
|  Campylobacter jejuni | Lactobacillus acidophilus* | Streptococcus agalactiae*  |
|  Candida albicans* | Lactobacillus brevis* | Streptococcus bovis  |
|  Candida glabrata | Lactobacillus delbrueckii subsp. lactis | Streptococcus mitis  |
|  Candida parapsilosis | Lactobacillus jensenii | Streptococcus mutans  |
|  Candida tropicalis | Legionella pneumophila | Streptococcus pneumoniae  |
|  Chlamydia pneumoniae* | Listeria monocytogenes | Streptococcus pyogenes  |
|  Chlamydia psittaci* | Micrococcus luteus* | Streptococcus salivarius  |
|  Chromobacterium violaceum | Mobiluncus mulieris | Streptococcus sanguinis  |
|  Chryseobacterium meningosepticum | Moraxella (Branhamella) catarrhalis | Streptomyces griseinus  |
|  Citrobacter freundii | Moraxella lacunata | Trichomonas vaginalis  |
|  Clostridium sporogenes | Moraxella osloensis | Ureaplasma urealyticum  |
|  Corynebacterium genitalium* | Morganella morganii | Veillonella parvula  |
|  Corynebacterium xerosis | Mycobacterium gordonae | Vibrio parahaemolyticus  |
|  Cryptococcus neoformans | Mycobacterium smegmatis* | Weissella paramesenteroides  |
|  Cytomegalovirus | Mycoplasma genitalium | Yersinia enterocolitica  |

* Tested with purified DNA or RNA and with culture isolates.

2. Comparison studies:
a. Method comparison with predicate device:
NA
b. Matrix comparison:
NA

3. Clinical studies:

Precision Study

A precision study was performed at three sites, two external and one internal. Each site was provided with a nine-member panel that was prepared targeting different combinations of CT and NG concentrations. The targeted concentration for CT ranged from 0 to 4,500 IFU/assay and for NG from 0 to 2,000 CFU/assay. Five replicates of each panel member were tested in each run. Thirty runs (10 per site) were performed for a total of 150 replicates of each panel member. The study included three amplification reagent lots. Each site tested two amplification reagent lots. A variance components analysis for a

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nested model was performed on delta cycle (DC) values, and the results are summarized in tables below.

|  Panel Member' | No. Testedb | No. Positive | Mean Delta Cycle | Within-Run Component SD' | Between-Run Component SD' | Between-Lot Component SD' | Between Site Component SD' | Total SD ,d  |
| --- | --- | --- | --- | --- | --- | --- | --- | --- |
|  1 | 150 | 150 | 14.78 | 0.300 | 0.194 | 0.066 | 0.137 | 0.388  |
|  2 | 149 | 149 | 15.15 | 0.385 | 0.139 | 0.285 | 0.000 | 0.499  |
|  3 | 149 | 149 | 3.21 | 0.591 | 0.241 | 0.000 | 0.047 | 0.640  |
|  4 | 150 | 150 | 8.89 | 0.385 | 0.156 | 0.169 | 0.162 | 0.477  |
|  5 | 148 | 0 | ... | ... | ... | ... | ... | ...  |
|  6 | 148 | 148 | 16.88 | 0.167 | 0.207 | 0.149 | 0.215 | 0.373  |
|  7 | 150 | 0 | ... | ... | ... | ... | ... | ...  |
|  8 | 149 | 1 | 0.67 | ... | ... | ... | ... | ...  |
|  9 | 148 | 103 | 1.09 | 0.201 | 0.000 | 0.192 | 0.000 | 0.665  |

${}^{a}$  CT concentrations were targeted approximately to 4500 IFU/assay in members 1,2,and 6 and to 45 IFU/assay in member 4. Member 3 was targeted approximately to 0.75 IFU/assay and member 9 to 0.2 IFU/assay both below the claimed assay LOD. Members 5,7,and 8 did not contain any CT organisms.
b Invalid replicates were excluded from the analysis.

The SD is based on positive replicates only. For member 9, analysis of all replicates with a cycle number  $(n = 133)$ , including those beyond the assay cutoff, resulted in a total SD of 0.966.

The total variability contains within-run, between-run, between-lot, and between-site variability.

Precision Study: NG Results

|  Panel Member' | No. Testedb | No. Positive | Mean Delta Cycle | Within-Run Component SD' | Between-Run Component SD' | Between-Lot Component SD' | Between Site Component SD' | Total SD e,d  |
| --- | --- | --- | --- | --- | --- | --- | --- | --- |
|  1 | 150 | 150 | 13.43 | 0.382 | 0.172 | 0.000 | 0.147 | 0.444  |
|  2 | 149 | 149 | 7.89 | 0.430 | 0.064 | 0.097 | 0.166 | 0.475  |
|  3 | 149 | 149 | 8.24 | 0.270 | 0.149 | 0.057 | 0.060 | 0.319  |
|  4 | 150 | 0 | ... | ... | ... | ... | ... |   |
|  5 | 148 | 148 | 7.80 | 0.231 | 0.198 | 0.040 | 0.185 | 0.358  |
|  6 | 147 | 0 | ... | ... | ... | ... | ... |   |
|  7 | 150 | 150 | 13.59 | 0.539 | 0.191 | 0.000 | 0.205 | 0.608  |
|  8 | 149 | 0 | ... | ... | ... | ... | ... |   |

# Summary of Clinical Studies

Performance characteristics of the Abbott RealTime CT/NG assay were established in a multi-center clinical study conducted in the United States. Specimens were prospectively collected from subjects at 16 geographically diverse sites that included physician private practices, public and private STD clinics, and a hospital emergency room. A total of 3,832 male and female, asymptomatic and symptomatic subjects were enrolled. Study subjects were classified as symptomatic if the subject reported STD-related symptoms.

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Specimens collected from each female subject included urine, endocervical swabs, self-collected vaginal swab, and clinician-collected vaginal swabs. Specimens collected from each male subject included urine and urethral swabs. Specimen testing methods included the Abbott RealTime CT/NG assay, two commercially available nucleic acid amplification tests (NAAT) for CT and NG, and culture for NG. The NAATs and the NG culture were used as reference assays in the clinical study.

For females, self-collected vaginal swab and urine specimens were collected first, followed by endocervical swab for culture. Remaining swab specimen collection was randomized to minimize bias. For males, urethral swab for culture was collected first. Remaining swab specimen collection was randomized to minimize bias. Urine specimen was collected after the swab specimens.

For each subject, a patient infected status was determined based on the combined results from the reference assays. A female subject was categorized as infected for CT or NG if a minimum of two positive results (at least one from each reference NAAT) were reported. A male subject was categorized as infected for CT or NG if a minimum of two positive results were reported. If the reference NG culture assay result was positive, the subject was categorized as infected regardless of NAAT results.

A female subject was categorized as not infected with CT or NG if at least one of the If patient infected status could not be determined due to missing and/or indeterminate results from the reference assays, the subject was excluded from the analysis. Patient infected status could not be determined for 33 subjects for CT and 35 subjects for NG.

The tables below summarize the clinical trial data.

Chlamydia trachomatis Clinical Sensitivity and Specificity
Female Specimens

|  Specimen | Symptoms | n | True Pos | False Pos | True Neg | False Neg | Sensitivity (95% C.I.) |   | Specificity (95% C.I.)  |   |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
|  Clinician-Collected Vaginal Swab | Symptomatic | 732 | 74 | 8 | 644 | 6 | 92.5 | (84.4, 97.2) | 99.8 | (97.6, 99.5)  |
|  Self-Collected Vaginal Swab | Symptomatic | 699 | 71 | 6 | 618 | 4 | 94.7 | (86.9, 98.5) | 99.0 | (97.9, 99.6)  |
|  Urine | Symptomatic | 746 | 75 | 3 | 662 | 6 | 92.6 | (84.6, 97.2) | 99.5 | (98.7, 99.9)  |
|   | Asymptomatic | 692 | 44 | 5 | 641 | 2 | 95.7 | (85.2, 99.5) | 99.2 | (98.2, 99.7)  |

Chlamydia trachomatis Clinical Sensitivity and Specificity
Male Specimens

|  Specimen | Symptoms | n | True Pos | False Pos | True Neg | False Neg | Sensitivity (95% C.I.) |   | Specificity (95% C.I.)  |   |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
|  Urethral Swab | Symptomatic | 825 | 167 | 11 | 635 | 12 | 93.3 | (88.6, 96.5) | 98.3 | (97.0, 99.1)  |
|  Urine | Symptomatic | 839 | 178 | 2 | 654 | 5 | 97.3 | (93.7, 99.1) | 99.7 | (98.9, 100.0)  |
|   | Asymptomatic | 659 | 89 | 2 | 566 | 2 | 97.8 | (92.3, 99.7) | 99.6 | (98.7, 100.0)  |

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## Neisseria gonorrhoeae Clinical Sensitivity and Specificity
### Female Specimens

|  Specimen | Symptoms | n | True Pos | False Pos | True Neg | False Neg | Sensitivity (95% C.I.) |   | Specificity (95% C.I.)  |   |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
|  Clinician-Collected Vaginal Swab | Symptomatic | 733 | 30 | 1 | 701 | 1 | 96.8 | (83.3, 99.9) | 99.9 | (99.2, 100.0)  |
|  Self-Collected Vaginal Swab | Symptomatic | 700 | 29 | 2 | 688 | 1 | 96.7 | (82.8, 99.9) | 99.7 | (98.9, 100.0)  |
|  Urine | Symptomatic | 746 | 30 | 2 | 712 | 2 | 93.8 | (79.2, 99.2) | 99.7 | (99.0, 100.0)  |
|   |  Asymptomatic | 693 | 20 | 3 | 667 | 3 | 87.0 | (66.4, 97.2) | 99.6 | (98.7, 99.9)  |

## Neisseria gonorrhoeae Clinical Sensitivity and Specificity
### Male Specimens

|  Specimen | Symptoms | n | True Pos | False Pos | True Neg | False Neg | Sensitivity (95% C.I.) |   | Specificity (95% C.I.)  |   |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
|  Urethral Swab | Symptomatic | 829 | 234 | 4 | 589 | 2 | 99.2 | (97.0, 99.9) | 99.3 | (98.3, 99.8)  |
|  Urine | Symptomatic | 840 | 237 | 3 | 597 | 3 | 98.8 | (96.4, 99.7) | 99.5 | (98.5, 99.9)  |
|   |  Asymptomatic | 658 | 11 | 0 | 647 | 0 | 100.0 | (71.5, 100.0) | 100.0 | (99.4, 100.0)  |

## CT Clinical Sensitivity and Specificity by Clinical Testing Site

|  Specimen | Testing Site | n | True Pos | False Pos | True Neg | False Neg | Sensitivity (95% C.I.) |   | Specificity (95% C.I.)  |   |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
|  Clinician-Collected Vaginal Swab | 1 | 391 | 41 | 4 | 342 | 4 | 91.1 | (78.8 – 97.5) | 98.8 | (97.1 – 99.7)  |
|   |  2 | 229 | 22 | 2 | 203 | 2 | 91.7 | (73.0 – 99.0) | 99.0 | (96.5 – 99.9)  |
|   |  3 | 112 | 11 | 2 | 99 | 0 | 100.0 | (71.5 – 100.0) | 98.0 | (93.0 – 99.8)  |
|   |  All | 732 | 74 | 8 | 644 | 6 | 92.5 | (84.4 – 97.2) | 98.8 | (97.6 – 99.5)  |
|  Self-Collected Vaginal Swab | 1 | 373 | 38 | 4 | 329 | 2 | 95.0 | (83.1 – 99.4) | 98.8 | (97.0 – 99.7)  |
|   |  2 | 220 | 22 | 1 | 195 | 2 | 91.7 | (73.0 – 99.0) | 99.5 | (97.2 – 100.0)  |
|   |  3 | 106 | 11 | 1 | 94 | 0 | 100.0 | (71.5 – 100.0) | 98.9 | (94.3 – 100.0)  |
|   |  All | 699 | 71 | 6 | 618 | 4 | 94.7 | (86.9 – 98.5) | 99.0 | (97.9 – 99.6)  |
|  Female Urine | 1 | 751 | 74 | 4 | 669 | 4 | 94.9 | (87.4 – 98.6) | 99.4 | (98.5 – 99.8)  |
|   |  2 | 388 | 28 | 1 | 357 | 2 | 93.3 | (77.9 – 99.2) | 99.7 | (98.5 – 100.0)  |
|   |  3 | 299 | 17 | 3 | 277 | 2 | 89.5 | (66.9 – 98.7) | 98.9 | (96.9 – 99.8)  |
|   |  All | 1438 | 119 | 8 | 1303 | 8 | 93.7 | (88.0 – 97.2) | 99.4 | (98.8 – 99.7)  |

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CT Clinical Sensitivity and Specificity by Clinical Testing Site

|  Specimen | Testing Site | n | True Pos | False Pos | True Neg | False Neg | Sensitivity (95% C.I.) |   | Specificity (95% C.I.)  |   |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
|  Male Urethral Swab | 1 | 574 | 124 | 6 | 440 | 4 | 96.9 | (92.2 – 99.1) | 98.7 | (97.1 – 99.5)  |
|   |  2 | 115 | 23 | 2 | 82 | 8 | 74.2 | (55.4 – 88.1) | 97.6 | (91.7 – 99.7)  |
|   |  3 | 136 | 20 | 3 | 113 | 0 | 100.0 | (83.2 – 100.0) | 97.4 | (92.6 – 99.5)  |
|   |  All | 825 | 167 | 11 | 635 | 12 | 93.3 | (88.6 – 96.5) | 98.3 | (97.0 – 99.1)  |
|  Male Urine | 1 | 936 | 184 | 1 | 746 | 5 | 97.4 | (93.9 – 99.1) | 99.9 | (99.3 – 100.0)  |
|   |  2 | 221 | 40 | 3 | 177 | 1 | 97.6 | (87.1 – 99.9) | 98.3 | (95.2 – 99.7)  |
|   |  3 | 341 | 43 | 0 | 297 | 1 | 97.7 | (88.0 – 99.9) | 100.0 | (98.8 – 100.0)  |
|   |  All | 1498 | 267 | 4 | 1220 | 7 | 97.4 | (94.8 – 99.0) | 99.7 | (99.2 – 99.9)  |

NG Clinical Sensitivity and Specificity by Clinical Testing Site

|  Specimen | Testing Site | n | True Pos | False Pos | True Neg | False Neg | Sensitivity (95% C.I.) |   | Specificity (95% C.I.)  |   |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
|  Clinician-Collected Vaginal Swab | 1 | 391 | 13 | 0 | 378 | 0 | 100.0 | (75.3 – 100.0) | 100.0 | (99.0 – 100.0)  |
|   |  2 | 230 | 13 | 1 | 215 | 1 | 92.9 | (66.1 – 99.8) | 99.5 | (97.4 – 100.0)  |
|   |  3 | 112 | 4 | 0 | 108 | 0 | 100.0 | (39.8 – 100.0) | 100.0 | (96.6 – 100.0)  |
|   |  All | 733 | 30 | 1 | 701 | 1 | 96.8 | (83.3 – 99.9) | 99.9 | (99.2 – 100.0)  |
|  Self-Collected Vaginal Swab | 1 | 376 | 12 | 0 | 364 | 0 | 100.0 | (73.5 – 100.0) | 100.0 | (99.0 – 100.0)  |
|   |  2 | 219 | 13 | 2 | 203 | 1 | 92.9 | (66.1 – 99.8) | 99.0 | (96.5 – 99.9)  |
|   |  3 | 105 | 4 | 0 | 101 | 0 | 100.0 | (39.8 – 100.0) | 100.0 | (96.4 – 100.0)  |
|   |  All | 700 | 29 | 2 | 668 | 1 | 96.7 | (82.8 – 99.9) | 99.7 | (98.9 – 100.0)  |
|  Female Urine | 1 | 754 | 26 | 4 | 720 | 4 | 86.7 | (69.3 – 96.2) | 99.4 | (98.6 – 99.8)  |
|   |  2 | 388 | 18 | 1 | 368 | 1 | 94.7 | (74.0 – 99.9) | 99.7 | (98.5 – 100.0)  |
|   |  3 | 297 | 6 | 0 | 291 | 0 | 100.0 | (54.1 – 100.0) | 100.0 | (98.7 – 100.0)  |
|   |  All | 1439 | 50 | 5 | 1379 | 5 | 90.9 | (80.0 – 97.0) | 99.6 | (99.2 – 99.9)  |

NG Clinical Sensitivity and Specificity by Clinical Testing Site

|  Specimen | Testing Site | n | True Pos | False Pos | True Neg | False Neg | Sensitivity (95% C.I.) |   | Specificity (95% C.I.)  |   |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
|  Male Urethral Swab | 1 | 574 | 164 | 3 | 406 | 1 | 99.4 | (96.7 – 100.0) | 99.3 | (97.9 – 99.8)  |
|   |  2 | 116 | 33 | 1 | 81 | 1 | 97.1 | (84.7 – 99.9) | 98.8 | (93.4 – 100.0)  |
|   |  3 | 139 | 37 | 0 | 102 | 0 | 100.0 | (90.5 – 100.0) | 100.0 | (96.4 – 100.0)  |
|   |  All | 829 | 234 | 4 | 589 | 2 | 99.2 | (97.0 – 99.9) | 99.3 | (98.3 – 99.8)  |
|  Male Urine | 1 | 936 | 173 | 3 | 758 | 2 | 98.9 | (95.9 – 99.9) | 99.6 | (98.9 – 99.9)  |
|   |  2 | 222 | 39 | 0 | 183 | 0 | 100.0 | (91.0 – 100.0) | 100.0 | (98.0 – 100.0)  |
|   |  3 | 340 | 36 | 0 | 303 | 1 | 97.3 | (85.8 – 99.9) | 100.0 | (98.8 – 100.0)  |
|   |  All | 1498 | 248 | 3 | 1244 | 3 | 98.8 | (96.5 – 99.8) | 99.8 | (99.3 – 100.0)  |

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CT Analysis According to Patient Infected Status
**INFECTED FEMALE** Subjects

|  NAAT 1 |   |   | NAAT 2 |   | RealTime CT/NG |   |   | No. of Subjects  |   |   |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
|  E | CCV | FU | E | FU | CCV | SCV | FU | Symptomatic (SCV/CCV/U) | Asymptomatic (Urine Only) | Total  |
|  + | + | + | + | + | + | + | + | 53 | 30 | 83  |
|  + | + | + | + | NA | + | + | + | 1 | 0 | 1  |
|  + | + | + | + | NA | + | NA | + | 2 | 0 | 2  |
|  + | + | NA | + | NA | + | + | NA | 0 | 1 | 1  |
|  + | + | + | NA | + | + | + | + | 1 | 0 | 1  |
|  + | + | + | + | + | + | NA | + | 2 | 1 | 3  |
|  + | + | + | + | + | NA | NA | + | 1 | 0 | 1  |
|  + | + | + | + | - | + | + | + | 2 | 2 | 4  |
|  + | + | + | - | + | + | + | + | 2 | 2 | 4  |
|  + | - | + | + | + | + | + | + | 2 | 0 | 2  |
|  + | + | - | + | - | + | + | + | 1 | 0 | 1  |
|  - | + | + | - | + | + | + | + | 1 | 1 | 2  |
|  - | + | - | + | + | + | + | + | 1 | 0 | 1  |
|  - | + | - | + | - | + | + | + | 0 | 1 | 1  |
|  - | - | + | - | + | + | + | + | 0 | 1 | 1  |
|  + | + | + | + | - | + | + | - | 3 | 0 | 3  |
|  + | + | - | + | NA | + | + | - | 1 | 0 | 1  |
|  + | + | - | + | - | + | + | - | 1 | 1 | 2  |
|  - | + | - | + | + | + | + | - | 1 | 0 | 1  |
|  + | + | + | - | + | - | NA | + | 1 | 0 | 1  |
|  - | + | + | - | + | - | + | + | 1 | 0 | 1  |
|  + | - | + | - | + | - | - | + | 1 | 0 | 1  |
|  - | - | + | NA | + | - | - | + | 0 | 1 | 1  |
|  - | - | + | - | + | - | - | + | 3 | 5 | 8  |
|  - | + | - | - | + | + | - | - | 0 | 1 | 1  |

E = Endocervical Swab Specimen; CCV = Clinician-Collected Vaginal Swab Specimen; FU = Female Urine Specimen; SCV = Self-Collected Vaginal Swab Specimen; U = Urine.
NA includes "indeterminate" results from reference assays, specimens not available, or missing results.

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CT Analysis According to Patient Infected Status
**NON-INFECTED FEMALE** Subjects

|  NAAT 1 |   |   | NAAT 2 |   | RealTime CT/NG |   |   | No. of Subjects  |   |   |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
|  E | CCV | FU | E | FU | CCV | SCV | FU | Symptomatic (SCV/CCV/U) | Asymptomatic (Urine Only) | Total  |
|  - | - | - | - | - | - | - | - | 524 | 528 | 1052  |
|  - | - | - | - | NA | - | - | - | 55 | 33 | 88  |
|  - | - | - | - | NA | - | - | NA | 2 | 1 | 3  |
|  - | - | - | - | NA | - | NA | - | 2 | 1 | 3  |
|  - | - | - | - | NA | NA | - | - | 2 | 1 | 3  |
|  - | - | - | - | NA | NA | - | NA | 1 | 0 | 1  |
|  - | - | - | NA | - | - | - | - | 9 | 28 | 37  |
|  - | - | - | NA | - | NA | - | - | 0 | 1 | 1  |
|  - | - | - | NA | - | NA | - | NA | 0 | 1 | 1  |
|  - | - | NA | - | - | - | - | - | 0 | 1 | 1  |
|  - | NA | - | - | - | - | - | - | 0 | 2 | 2  |
|  NA | - | - | - | - | NA | - | - | 0 | 1 | 1  |
|  - | - | - | - | - | - | - | NA | 2 | 7 | 9  |
|  - | - | - | - | - | - | NA | - | 30 | 17 | 47  |
|  - | - | - | - | - | NA | - | - | 6 | 7 | 13  |
|  - | - | - | - | - | - | NA | NA | 3 | 2 | 5  |
|  - | - | - | - | - | NA | - | NA | 1 | 2 | 3  |
|  - | - | - | - | - | NA | NA | - | 11 | 2 | 13  |
|  - | - | - | - | + | - | - | - | 1 | 2 | 3  |
|  - | - | - | NA | + | - | - | - | 1 | 0 | 1  |
|  - | - | - | + | - | - | - | - | 5 | 0 | 5  |
|  - | - | - | + | NA | - | - | - | 0 | 1 | 1  |
|  - | - | - | + | - | NA | - | - | 1 | 0 | 1  |
|  - | - | + | - | - | - | - | - | 0 | 2 | 2  |
|  - | - | + | - | - | NA | NA | - | 1 | 0 | 1  |
|  - | + | - | - | - | - | - | - | 3 | 2 | 5  |
|  - | + | - | - | - | - | NA | - | 0 | 1 | 1  |
|  + | - | - | - | - | - | - | - | 2 | 2 | 4  |
|  + | + | - | - | - | - | - | - | 0 | 2 | 2  |

E = Endocervical Swab Specimen; CCV = Clinician-Collected Vaginal Swab Specimen; FU = Female Urine Specimen; SCV = Self-Collected Vaginal Swab Specimen; U = Urine.
NA includes "indeterminate" results from reference assays, specimens not available, or missing results.

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# CT Analysis According to Patient Infected Status
## NON-INFECTED FEMALE Subjects

|  NAAT 1 |   |   | NAAT 2 |   | RealTime CT/NG |   |   | No. of Subjects  |   |   |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
|  E | CCV | FU | E | FU | CCV | SCV | FU | Symptomatic (SCV/CCV/U) | Asymptomatic (Urine Only) | Total  |
|  - | - | - | - | - | - | - | + | 1 | 1 | 2  |
|  - | - | + | - | - | - | - | + | 0 | 2 | 2  |
|  - | + | + | - | - | - | NA | + | 1 | 0 | 1  |
|  - | - | - | - | NA | - | + | - | 1 | 0 | 1  |
|  - | - | - | - | - | - | + | - | 2 | 1 | 3  |
|  - | + | - | - | - | - | + | - | 0 | 1 | 1  |
|  - | + | - | - | - | NA | + | - | 0 | 1 | 1  |
|  - | - | - | - | NA | + | - | - | 1 | 0 | 1  |
|  - | - | - | - | - | + | - | - | 1 | 1 | 2  |
|  - | - | - | - | - | + | NA | - | 1 | 0 | 1  |
|  - | + | - | - | - | + | NA | - | 1 | 0 | 1  |
|  + | + | - | - | - | + | - | + | 0 | 1 | 1  |
|  - | + | + | - | - | + | NA | + | 1 | 0 | 1  |
|  - | + | - | - | - | + | + | - | 1 | 0 | 1  |
|  + | + | - | - | - | + | + | - | 1 | 3 | 4  |
|  + | + | + | - | - | + | + | NA | 1 | 0 | 1  |
|  + | + | + | - | - | + | + | + | 0 | 1 | 1  |

E = Endocervical Swab Specimen; CCV = Clinician-Collected Vaginal Swab Specimen; FU = Female Urine Specimen; SCV = Self-Collected Vaginal Swab Specimen; U = Urine.
NA includes "indeterminate" results from reference assays, specimens not available, or missing results.

# CT Analysis According to Patient Infected Status
## INFECTED MALE Subjects

|  NAAT 1 |   | NAAT 2 | RealTime CT/NG |   | No. of Subjects  |   |   |
| --- | --- | --- | --- | --- | --- | --- | --- |
|  MUS | MU | MU | MUS | MU | Symptomatic (SCV/CCV/U) | Asymptomatic (Urine Only) | Total  |
|  + | + | + | + | + | 144 | 70 | 214  |
|  + | + | NA | + | + | 7 | 2 | 9  |
|  NA | + | + | + | + | 1 | 0 | 1  |
|  + | + | + | NA | + | 3 | 3 | 6  |
|  + | + | - | + | + | 9 | 3 | 12  |
|  + | + | - | + | NA | 1 | 0 | 1  |
|  + | + | - | NA | + | 2 | 0 | 2  |
|  + | - | + | + | + | 1 | 0 | 1  |
|  - | + | + | + | + | 0 | 2 | 2  |
|  + | + | + | + | - | 1 | 0 | 1  |
|  + | + | - | + | - | 3 | 0 | 3  |
|  + | - | + | + | - | 0 | 1 | 1  |
|  + | + | + | - | + | 8 | 3 | 11  |
|  - | + | + | - | + | 3 | 6 | 9  |
|  + | + | - | - | - | 1 | 1 | 2  |

MUS = Male Urethral Swab Specimen; MU = Male Urine Specimen; U = Urine.
NA includes "indeterminate" results from reference assays, specimens not available, or missing results.

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# CT Analysis According to Patient Infected Status
## NON-INFECTED MALE Subjects

|  NAAT 1 |   | NAAT 2 | RealTime CT/NG |   | No. of Subjects  |   |   |
| --- | --- | --- | --- | --- | --- | --- | --- |
|  MUS | MU | MU | MUS | MU | Symptomatic (SCV/CCV/U) | Asymptomatic (Urine Only) | Total  |
|  - | - | - | - | - | 582 | 510 | 1092  |
|  - | - | NA | - | - | 33 | 39 | 72  |
|  - | - | NA | NA | - | 1 | 1 | 2  |
|  - | NA | - | - | - | 2 | 0 | 2  |
|  NA | - | - | NA | - | 1 | 0 | 1  |
|  - | - | - | - | NA | 3 | 2 | 5  |
|  - | - | - | NA | - | 11 | 4 | 15  |
|  - | - | + | - | - | 3 | 2 | 5  |
|  - | + | - | - | - | 4 | 2 | 6  |
|  + | - | - | - | - | 7 | 2 | 9  |
|  + | - | - | NA | - | 0 | 1 | 1  |
|  - | - | - | - | + | 1 | 0 | 1  |
|  - | - | + | - | + | 0 | 1 | 1  |
|  - | + | - | - | + | 0 | 1 | 1  |
|  - | - | - | + | - | 5 | 2 | 7  |
|  - | - | NA | + | - | 0 | 1 | 1  |
|  - | - | + | + | - | 2 | 0 | 2  |
|  + | - | - | + | - | 3 | 2 | 5  |
|  - | - | + | + | + | 1 | 0 | 1  |

MUS = Male Urethral Swab Specimen; MU = Male Urine Specimen; U = Urine.
NA includes "indeterminate" results from reference assays, specimens not available, or missing results.

# NG Analysis According to Patient Infected Status
## INFECTED FEMALE Subjects

|  Culture | NAAT 1 |   |   | NAAT 2 |   | RealTime CT/NG |   |   | No. of Subjects  |   |   |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
|  E | E | CCV | FU | E | FU | CCV | SCV | FU | Symptomatic (SCV/CCV/U) | Asymptomatic (Urine Only) | Total  |
|  + | + | + | + | + | + | + | + | + | 12 | 8 | 20  |
|  + | + | + | + | + | NA | + | NA | + | 1 | 0 | 1  |
|  + | + | + | + | + | + | NA | NA | + | 1 | 0 | 1  |
|  + | + | + | + | + | - | + | + | + | 0 | 1 | 1  |
|  - | + | + | + | + | + | + | + | + | 5 | 8 | 13  |
|  - | + | + | + | + | - | + | + | + | 4 | 0 | 4  |
|  - | + | + | + | - | + | + | + | + | 1 | 0 | 1  |
|  - | NA | + | + | - | + | + | + | + | 0 | 1 | 1  |
|  + | - | + | - | + | + | + | + | + | 1 | 0 | 1  |
|  - | + | + | - | + | NA | + | + | + | 1 | 0 | 1  |
|  - | + | + | - | - | + | + | + | + | 1 | 0 | 1  |
|  - | + | - | + | - | + | + | + | + | 0 | 1 | 1  |
|  - | - | + | - | + | NA | + | + | + | 0 | 1 | 1  |
|  - | - | + | - | + | - | + | + | + | 1 | 0 | 1  |
|  + | + | + | - | + | NA | + | + | - | 0 | 1 | 1  |
|  + | + | + | - | + | - | + | + | - | 0 | 1 | 1  |
|  - | + | + | + | + | - | + | + | - | 1 | 0 | 1  |
|  - | + | + | - | + | - | + | + | - | 1 | 1 | 2  |
|  - | - | - | + | - | + | - | - | + | 1 | 1 | 2  |

E = Endocervical Swab Specimen; CCV = Clinician-Collected Vaginal Swab Specimen; FU = Female Urine Specimen; SCV = Self-Collected Vaginal Swab Specimen; U = Urine.
NA includes "indeterminate" results from reference assays, specimens not available, or missing results.

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# NG Analysis According to Patient Infected Status
## NON-INFECTED FEMALE Subjects

|  Culture | NAAT 1 |   |   | NAAT 2 |   | RealTime CT/NG |   |   | No. of Subjects  |   |   |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
|  E | E | CCV | FU | E | FU | CCV | SCV | FU | Symptomatic (SCV/CCV/U) | Asymptomatic (Urine Only) | Total  |
|  - | - | - | - | - | - | - | - | - | 546 | 538 | 1084  |
|  - | - | - | - | - | NA | - | - | - | 65 | 34 | 99  |
|  - | - | - | - | - | NA | NA | - | - | 2 | 1 | 3  |
|  - | - | - | - | - | NA | - | NA | - | 3 | 0 | 3  |
|  - | - | - | - | - | NA | - | - | NA | 1 | 0 | 1  |
|  - | - | - | - | NA | - | - | - | - | 8 | 27 | 35  |
|  - | - | - | - | NA | - | NA | - | NA | 0 | 1 | 1  |
|  NA | - | - | - | NA | - | - | - | - | 0 | 3 | 3  |
|  NA | - | - | - | NA | - | NA | - | - | 0 | 1 | 1  |
|  - | - | NA | - | - | - | - | - | - | 0 | 2 | 2  |
|  NA | - | NA | - | - | - | - | - | - | 0 | 1 | 1  |
|  - | NA | - | - | - | - | NA | - | - | 0 | 1 | 1  |
|  NA | - | - | - | - | - | - | - | - | 1 | 1 | 2  |
|  - | - | - | - | - | - | - | - | NA | 4 | 8 | 12  |
|  - | - | - | - | - | - | - | NA | - | 31 | 16 | 47  |
|  - | - | - | - | - | - | NA | - | - | 5 | 7 | 12  |
|  - | - | - | - | - | - | - | NA | NA | 3 | 3 | 6  |
|  - | - | - | - | - | - | NA | - | NA | 1 | 4 | 5  |
|  - | - | - | - | - | - | NA | NA | - | 13 | 3 | 16  |
|  - | - | - | - | - | + | - | - | - | 26 | 18 | 44  |
|  - | - | - | - | - | + | - | NA | - | 3 | 1 | 4  |

E = Endocervical Swab Specimen; CCV = Clinician-Collected Vaginal Swab Specimen; FU = Female Urine Specimen; SCV = Self-Collected Vaginal Swab Specimen; U = Urine.
NA includes "indeterminate" results from reference assays, specimens not available, or missing results.

# NG Analysis According to Patient Infected Status
## NON-INFECTED FEMALE Subjects

|  Culture | NAAT 1 |   |   | NAAT 2 |   | RealTime CT/NG |   |   | No. of Subjects  |   |   |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
|  E | E | CCV | FU | E | FU | CCV | SCV | FU | Symptomatic (SCV/CCV/U) | Asymptomatic (Urine Only) | Total  |
|  - | - | - | - | + | - | - | - | - | 2 | 6 | 8  |
|  - | - | - | - | + | NA | - | - | NA | 1 | 0 | 1  |
|  - | - | - | + | - | - | - | - | - | 1 | 1 | 2  |
|  - | - | + | - | - | - | - | - | - | 2 | 0 | 2  |
|  - | + | - | - | - | - | - | - | - | 2 | 1 | 3  |
|  - | + | - | - | - | - | NA | - | - | 1 | 0 | 1  |
|  - | - | - | - | + | + | - | - | - | 0 | 1 | 1  |
|  - | - | - | + | - | - | - | - | + | 0 | 3 | 3  |
|  - | + | + | + | - | - | - | NA | + | 1 | 0 | 1  |
|  - | - | + | - | - | - | - | + | - | 1 | 0 | 1  |
|  - | - | - | - | - | - | + | - | - | 0 | 1 | 1  |
|  - | - | - | - | - | NA | + | - | - | 0 | 1 | 1  |
|  - | - | + | - | - | - | + | - | - | 0 | 1 | 1  |
|  - | + | + | - | - | - | + | - | - | 0 | 1 | 1  |

E = Endocervical Swab Specimen; CCV = Clinician-Collected Vaginal Swab Specimen; FU = Female Urine Specimen; SCV = Self-Collected Vaginal Swab Specimen; U = Urine.
NA includes "indeterminate" results from reference assays, specimens not available, or missing results.

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# NG Analysis According to Patient Infected Status
## INFECTED MALE Subjects

|  Culture | NAAT 1 |   | NAAT 2 | RealTime CT/NG |   | No. of Subjects  |   |   |
| --- | --- | --- | --- | --- | --- | --- | --- | --- |
|  MUS | MUS | MU | MU | MUS | MU | Symptomatic (SCV/CCV/U) | Asymptomatic (Urine Only) | Total  |
|  + | + | + | + | + | + | 169 | 2 | 171  |
|  + | + | + | NA | + | + | 3 | 1 | 4  |
|  + | + | NA | NA | + | NA | 1 | 0 | 1  |
|  + | + | NA | + | + | + | 1 | 0 | 1  |
|  NA | + | + | + | + | + | 6 | 0 | 6  |
|  + | + | + | + | NA | + | 6 | 0 | 6  |
|  + | + | + | - | + | + | 9 | 0 | 9  |
|  + | + | - | + | + | + | 2 | 0 | 2  |
|  - | + | + | + | + | + | 35 | 6 | 41  |
|  - | + | + | + | + | NA | 1 | 0 | 1  |
|  - | + | + | NA | + | + | 2 | 0 | 2  |
|  - | NA | + | + | + | + | 1 | 0 | 1  |
|  - | + | + | - | + | + | 1 | 0 | 1  |
|  + | - | - | + | + | + | 1 | 0 | 1  |
|  - | + | + | + | + | - | 1 | 0 | 1  |
|  + | + | - | - | + | - | 1 | 0 | 1  |
|  + | + | + | + | - | + | 1 | 0 | 1  |
|  - | - | + | + | - | + | 0 | 2 | 2  |
|  + | - | - | - | - | - | 1 | 0 | 1  |

MUS = Male Urethral Swab Specimen; MU = Male Urine Specimen; U = Urine.
NA includes "indeterminate" results from reference assays, specimens not available, or missing results.

# NG Analysis According to Patient Infected Status
## NON-INFECTED MALE Subjects

|  Culture | NAAT 1 |   | NAAT 2 | RealTime CT/NG |   | No. of Subjects  |   |   |
| --- | --- | --- | --- | --- | --- | --- | --- | --- |
|  MUS | MUS | MU | MU | MUS | MU | Symptomatic (SCV/CCV/U) | Asymptomatic (Urine Only) | Total  |
|  - | - | - | - | - | - | 516 | 559 | 1075  |
|  - | - | - | NA | - | - | 40 | 42 | 82  |
|  - | - | - | NA | NA | - | 1 | 1 | 2  |
|  - | - | NA | - | - | - | 1 | 0 | 1  |
|  - | NA | - | - | - | - | 1 | 1 | 2  |
|  - | NA | - | - | NA | - | 1 | 0 | 1  |
|  NA | - | - | - | - | - | 7 | 6 | 13  |
|  - | - | - | - | - | NA | 3 | 4 | 7  |
|  - | - | - | - | NA | - | 8 | 6 | 14  |
|  - | - | - | + | - | - | 16 | 25 | 41  |
|  NA | - | - | + | - | - | 0 | 1 | 1  |
|  - | - | + | - | - | - | 2 | 3 | 5  |
|  - | + | - | - | - | - | 2 | 2 | 4  |
|  - | - | - | - | - | + | 1 | 0 | 1  |
|  - | - | - | - | + | - | 0 | 1 | 1  |
|  - | + | - | - | + | - | 2 | 0 | 2  |
|  - | - | - | + | + | + | 1 | 0 | 1  |
|  - | + | - | - | + | + | 1 | 0 | 1  |

MUS = Male Urethral Swab Specimen; MU = Male Urine Specimen; U = Urine.
NA includes "indeterminate" results from reference assays, specimens not available, or missing results.

{16}

Page 17 of 19

Prevalence of *C. trachomatis* and/or *N. gonorrhoeae* by Collection Site Symptomatic and Asymptomatic Female Urine Specimens

|  Female Urine
% Prevalence (Number Positive/Number Tested)  |   |   |   |   |   |   |
| --- | --- | --- | --- | --- | --- | --- |
|  Site^{a} | CT+/ NG+ |   | CT+/ NG^{-b} |   | CT –/ NG+^{b}  |   |
|  1 | 0.0 | (0/61) | 0.0 | (0/61) | 0.0 | (0/61)  |
|  3 | 1.6 | (3/183) | 4.4 | (8/183) | 1.1 | (2/183)  |
|  4 | 0.0 | (0/50) | 8.0 | (4/50) | 2.0 | (1/50)  |
|  5 | 0.0 | (0/21) | 0.0 | (0/21) | 0.0 | (0/21)  |
|  6 | 0.0 | (0/16) | 6.3 | (1/16) | 6.3 | (1/16)  |
|  7 | 3.1 | (9/295) | 8.5 | (25/295) | 3.7 | (11/295)  |
|  8 | 0.0 | (0/56) | 7.1 | (4/56) | 3.6 | (2/56)  |
|  9 | 4.6 | (3/65) | 16.9 | (11/65) | 6.2 | (4/65)  |
|  10 | 2.4 | (4/168) | 10.7 | (18/168) | 1.8 | (3/168)  |
|  11 | 2.1 | (6/289) | 9.3 | (27/289) | 1.4 | (4/289)  |
|  12 | 0.0 | (0/11) | 0.0 | (0/11) | 0.0 | (0/11)  |
|  13 | 0.0 | (0/71) | 0.0 | (0/71) | 0.0 | (0/71)  |
|  14 | 0.0 | (0/80) | 3.8 | (3/80) | 0.0 | (0/80)  |
|  15 | 1.7 | (1/60) | 0.0 | (0/60) | 0.0 | (0/60)  |
|  16 | 0.0 | (0/25) | 0.0 | (0/25) | 4.0 | (1/25)  |
|  All | 1.8 | (26/1451) | 7.0 | (101/1451) | 2.0 | (29/1451)  |

a No evaluable results were available from Site 2.
b Does not include specimens that were positive for both CT and NG.

Prevalence of *C. trachomatis* and/or *N. gonorrhoeae* by Collection Site: Symptomatic Clinician-Collected and Symptomatic Self-Collected Vaginal Swab Specimens

|  Clinician-Collected Vaginal Swab
% Prevalence (Number Positive/Number Tested) |   |   |   |   |   |   | Self-Collected Vaginal Swab
% Prevalence (Number Positive/Number Tested)  |   |   |   |   |   |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
|  Site^{a} | CT+/ NG+ |   | CT+/ NG^{-b} |   | CT –/ NG+^{b} |   | CT+/ NG+ |   | CT+/ NG^{-b} |   | CT –/ NG+^{b}  |   |
|  1 | 0.0 | (0/23) | 0.0 | (0/23) | 0.0 | (0/23) | 0.0 | (0/24) | 0.0 | (0/24) | 0.0 | (0/24)  |
|  3 | 2.3 | (2/88) | 4.5 | (4/88) | 2.3 | (2/88) | 2.4 | (2/84) | 4.8 | (4/84) | 2.4 | (2/84)  |
|  4 | 0.0 | (0/42) | 9.5 | (4/42) | 2.4 | (1/42) | 0.0 | (0/37) | 10.8 | (4/37) | 2.7 | (1/37)  |
|  5 | 0.0 | (0/15) | 0.0 | (0/15) | 0.0 | (0/15) | 0.0 | (0/15) | 0.0 | (0/15) | 0.0 | (0/15)  |
|  6 | 0.0 | (0/16) | 12.5 | (2/16) | 6.3 | (1/16) | 0.0 | (0/14) | 7.1 | (1/14) | 7.1 | (1/14)  |
|  7 | 3.4 | (7/207) | 10.6 | (22/207) | 3.4 | (7/207) | 3.6 | (7/196) | 10.2 | (20/196) | 4.1 | (8/196)  |
|  8 | 0.0 | (0/47) | 6.4 | (3/47) | 2.1 | (1/47) | 0.0 | (0/49) | 8.2 | (4/49) | 2.0 | (1/49)  |
|  9 | 7.0 | (3/43) | 14.0 | (6/43) | 0.0 | (0/43) | 5.6 | (2/36) | 11.1 | (4/36) | 0.0 | (0/36)  |
|  10 | 2.4 | (3/125) | 11.2 | (14/125) | 1.6 | (2/125) | 2.5 | (3/120) | 12.5 | (15/120) | 1.7 | (2/120)  |
|  11 | 2.9 | (1/34) | 23.5 | (8/34) | 2.9 | (1/34) | 2.9 | (1/34) | 23.5 | (8/34) | 2.9 | (1/34)  |
|  12 | 0.0 | (0/10) | 0.0 | (0/10) | 0.0 | (0/10) | 0.0 | (0/10) | 0.0 | (0/10) | 0.0 | (0/10)  |
|  13 | 0.0 | (0/17) | 0.0 | (0/17) | 0.0 | (0/17) | 0.0 | (0/17) | 0.0 | (0/17) | 0.0 | (0/17)  |
|  14 | 0.0 | (0/38) | 5.3 | (2/38) | 0.0 | (0/38) | 0.0 | (0/36) | 2.8 | (1/36) | 0.0 | (0/36)  |
|  15 | 3.7 | (1/27) | 0.0 | (0/27) | 0.0 | (0/27) | 3.6 | (1/28) | 0.0 | (0/28) | 0.0 | (0/28)  |
|  16 | 0.0 | (0/12) | 0.0 | (0/12) | 0.0 | (0/12) | 0.0 | (0/12) | 0.0 | (0/12) | 0.0 | (0/12)  |
|  All | 2.3 | (17/744) | 8.7 | (65/744) | 2.0 | (15/744) | 2.2 | (16/712) | 8.6 | (61/712) | 2.2 | (16/712)  |

a No evaluable results were available from Site 2.
b Does not include specimens that were positive for both CT and NG.

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Prevalence of *C. trachomatis* and/or *N. gonorrhoeae* by Collection Site Symptomatic Male Urethral Swab

|  Site^{a,b} | Urethral Swab
% Prevalence (Number Positive/Number Tested)  |   |   |   |   |   |
| --- | --- | --- | --- | --- | --- | --- |
|   |  CT+/ NG+ |   | CT+/ NG–^{c} |   | CT–/ NG+^{c}  |   |
|  3 | 14.2 | (17/120) | 13.3 | (16/120) | 19.2 | (23/120)  |
|  4 | 9.0 | (6/67) | 6.0 | (4/67) | 9.0 | (6/67)  |
|  5 | 0.0 | (0/23) | 8.7 | (2/23) | 4.3 | (1/23)  |
|  6 | 0.0 | (0/11) | 18.2 | (2/11) | 9.1 | (1/11)  |
|  7 | 9.5 | (9/95) | 17.9 | (17/95) | 20.0 | (19/95)  |
|  8 | 7.3 | (13/178) | 16.3 | (29/178) | 20.2 | (36/178)  |
|  9 | 12.0 | (20/167) | 13.8 | (23/167) | 37.1 | (62/167)  |
|  10 | 4.9 | (4/81) | 18.5 | (15/81) | 12.3 | (10/81)  |
|  12 | 0.0 | (0/3) | 0.0 | (0/3) | 0.0 | (0/3)  |
|  13 | 0.0 | (0/26) | 3.8 | (1/26) | 0.0 | (0/26)  |
|  14 | 0.0 | (0/15) | 0.0 | (0/15) | 13.3 | (2/15)  |
|  15 | 0.0 | (0/7) | 0.0 | (0/7) | 0.0 | (0/7)  |
|  16 | 3.0 | (1/33) | 0.0 | (0/33) | 18.2 | (6/33)  |
|  All | 8.5 | (70/826) | 13.2 | (109/826) | 20.1 | (166/826)  |

a Male specimens were not collected from Site 1.
b No symptomatic Male Urethral Swab specimens were available from site 2 and 11.
c Does not include specimens that were positive for both CT and NG.

Prevalence of *C. trachomatis* and/or *N. gonorrhoeae* by Collection Site: Symptomatic and Asymptomatic Male Urine Specimens

|  Site^{a} | Urine
% Prevalence (Number Positive/Number Tested)  |   |   |   |   |   |
| --- | --- | --- | --- | --- | --- | --- |
|   |  CT+/ NG+ |   | CT+/ NG–^{b} |   | CT–/ NG+^{b}  |   |
|  2 | 0.0 | (0/6) | 0.0 | (0/6) | 0.0 | (0/6)  |
|  3 | 13.7 | (25/183) | 9.8 | (18/183) | 12.6 | (23/183)  |
|  4 | 4.0 | (4/101) | 5.9 | (6/101) | 6.9 | (7/101)  |
|  5 | 0.0 | (0/34) | 5.9 | (2/34) | 2.9 | (1/34)  |
|  6 | 0.0 | (0/53) | 18.9 | (10/53) | 1.9 | (1/53)  |
|  7 | 6.7 | (12/179) | 16.8 | (30/179) | 10.1 | (18/179)  |
|  8 | 4.8 | (14/291) | 14.8 | (43/291) | 12.7 | (37/291)  |
|  9 | 10.1 | (21/208) | 20.2 | (42/208) | 31.3 | (65/208)  |
|  10 | 2.8 | (4/145) | 21.4 | (31/145) | 6.9 | (10/145)  |
|  11 | 0.0 | (0/2) | 100.0 | (2/2) | 0.0 | (0/2)  |
|  12 | 0.0 | (0/3) | 0.0 | (0/3) | 0.0 | (0/3)  |
|  13 | 0.0 | (0/60) | 1.7 | (1/60) | 0.0 | (0/60)  |
|  14 | 0.0 | (0/75) | 1.3 | (1/75) | 2.7 | (2/75)  |
|  15 | 0.0 | (0/55) | 3.6 | (2/55) | 0.0 | (0/55)  |
|  16 | 0.0 | (0/101) | 2.0 | (2/101) | 5.9 | (6/101)  |
|  All | 5.3 | (80/1496) | 12.7 | (190/1496) | 11.4 | (170/1496)  |

a Male specimens were not collected from Site 1.
b Does not include specimens that were positive for both CT and NG.

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Positive and Negative Predictive Values for Hypothetical Prevalence Rates for Chlamydia trachomatis

|  Prevalence Rate (%) | Sensitivity (%) | Specificity (%) | Positive Predictive Value (%) | Negative Predictive Value (%)  |
| --- | --- | --- | --- | --- |
|  0.5 | 95.0 | 99.2 | 37.4 | 100.0  |
|  1.0 | 95.0 | 99.2 | 54.5 | 99.9  |
|  2.0 | 95.0 | 99.2 | 70.8 | 99.9  |
|  5.0 | 95.0 | 99.2 | 86.2 | 99.7  |
|  10.0 | 95.0 | 99.2 | 93.0 | 99.4  |
|  15.0 | 95.0 | 99.2 | 95.4 | 99.1  |
|  20.0 | 95.0 | 99.2 | 96.7 | 98.8  |
|  25.0 | 95.0 | 99.2 | 97.5 | 98.3  |
|  30.0 | 95.0 | 99.2 | 98.1 | 97.9  |

Positive and Negative Predictive Values for Hypothetical Prevalence Rates for Neisseria gonorrhoeae

|  Prevalence Rate (%) | Sensitivity (%) | Specificity (%) | Positive Predictive Value (%) | Negative Predictive Value (%)  |
| --- | --- | --- | --- | --- |
|  0.5 | 98.0 | 99.7 | 62.1 | 100.0  |
|  1.0 | 98.0 | 99.7 | 76.7 | 100.0  |
|  2.0 | 98.0 | 99.7 | 87.0 | 100.0  |
|  5.0 | 98.0 | 99.7 | 94.5 | 99.9  |
|  10.0 | 98.0 | 99.7 | 97.3 | 99.8  |
|  15.0 | 98.0 | 99.7 | 98.3 | 99.6  |
|  20.0 | 98.0 | 99.7 | 98.8 | 99.5  |
|  25.0 | 98.0 | 99.7 | 99.1 | 99.3  |
|  30.0 | 98.0 | 99.7 | 99.3 | 99.1  |

N. Proposed Labeling:
The labeling is sufficient and it satisfies the requirements of 21 CFR Part 809.10.

O. Conclusion:
The submitted information in this premarket notification is complete and supports a substantial equivalence decision.

---

**Source:** [https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/MKZ/K080739](https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/MKZ/K080739)

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