ABBOTT REALTIME CT/NG ASSAY AND MULTI-COLLECT SPECIMEN COLLECTION KIT

K080739 · Abbott Molecular, Inc. · MKZ · Jul 10, 2008 · Microbiology

Device Facts

• Record ID: K080739
• Device Name: ABBOTT REALTIME CT/NG ASSAY AND MULTI-COLLECT SPECIMEN COLLECTION KIT
• Applicant: Abbott Molecular, Inc.
• Product Code: MKZ · Microbiology
• Decision Date: Jul 10, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.3120
• Device Class: Class 1

Intended 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.

Indications for Use

Indicated for qualitative detection of Chlamydia trachomatis and Neisseria gonorrhoeae DNA in symptomatic individuals (clinician-collected vaginal/male urethral swabs, patient-collected vaginal swabs, female/male urine) and asymptomatic individuals (female/male urine).

Regulatory Classification

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)
• Becton Dickenson ProbeTec™ ET Chlamydia trachomatis /Neisseria gonorrhoeae Amplified DNA Assay (K012351)
• Gen-Probe® APTIMA™ Unisex Swab Specimen Collection Kit (K043224)
• Gen-Probe APTIMA Urine Specimen Collection Kit (K043144)
• Gen-Probe APTIMA Vaginal Swab Specimen Collection Kit (K032554)
• BD ProbeTec ET Urine Processing Kit (K052224)

Submission Summary (Full Text)

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K080739

## 2.0 510(k) Summary

# JUL 1 0 2008

Abbott® RealTime CT/NG assay and an ancillary kit called the Abbott® multi-Collect™ Specimen Collection Kit

| Submitted By: | Company Contact: |
|-------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------|
| Abbott Molecular Inc.<br>1300 E. Touhy Avenue<br>Des Plaines, IL 60018<br>phone: [phone]<br>fax: [phone]) | Paula Martin<br>Senior Manager Regulatory and Clinical Affairs<br>[phone]<br>[phone]<br>e-mail: [e-mail] |
| | Morteza Minaee<br>Director of Regulatory and Clinical Affairs<br>[phone]<br>[phone]<br>e-mail: [e-mail] |

| Trade Name: | Abbott® RealTime CT/NG (List No. 8L07) and<br>Abbott® multi-Collect™ Specimen Collection Kit (List No. 9K12) |
|--------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Common Name: | In vitro polymerase chain reaction (PCR) assay for<br><i>Chlamydia trachomatis</i> and <i>Neisseria gonorrhoeae</i> and<br>Microbiological Specimen Collection and Transport Device |

Classification Name: Nucleic acid test (NAT)

Classification Code: Product Codc: LSL, MKZ Registration Number: 866.3390 (Neisseria), 866.3120 (Chlamydia) Device Class: 2 (Neisseria), 1 (Chlamydia

# Substantially Equivalent Devices:

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 Endoccrvical and Urethral Swab Specimens (K043224);

Gen-Probe APTIMA Urine Specimen Collection Kit for Male and Female Urine (Assigned 510(k) No. 043144);

Gen-Probe APTIMA Vaginal Swab Specimen Collection Kit (Assigned 510(k) No. K032554);

BD ProbeTec ET Urine Processing Kit Assigned 510(k) No. (K052224).

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#### 2.1 Purpose of the Submission

The purpose of this 510(k) is to gain clearance to market the Abbott RealTime CT/NG (List No. 8L07) assay and the Abbott multi-Collect Specimen Collection Kit (List No. 9K12).

#### 2.2 Date of Preparation

March 11, 2008.

#### 2.3 Manufacturer:

Abbott Molecular Inc. is the legal manufacturer of the Abbott RealTime CT/NG (List No. 8L07) assay and the Abbott multi-Collect Specimen Collection Kit (List No. 9K12).

| Name: | Patrick Groody, PhD |
|-----------|------------------------------------------------------------------------|
| Title: | Vice President Quality Assurance and Operations |
| Telephone | [phone] |
| Fax: | [phone] |
| Email: | [e-mail] |
| Address: | Abbott Molecular Inc.<br>1300 E. Touhy Avenue<br>Des Plaines, IL 60018 |

Establishment Registration No.: 3005248192

The Abbott multi-Collect Specimen Collection Kit (List No. 9K12) is manufactured and assembled at the MML Diagnostic Packaging, Inc. facility indicated below:

Name: Lynn Creitz Title: Director Manufacturing Operations Telephone: [phone] Fax: [phone] [e-mail] Email:

MML Diagnostic Packaging, Inc. 1625 NW Sundial Road PO Box 458 Troutdale, OR 97060

Establishment Registration No .: 3018348

Abbott RealTime CT/NG // multi-Collect Specimen Collection Kit March 2008 Soc 2 511Kk) Summary_mw9

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## 2.4 Intended Use

The proposed intended use for the Abbott RealTime CT/NG assay is:

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 proposed intended use for the Abbott multi-Collect Specimen Collection Kit is:

The Abbott multi-Collect Specimen Collection Kit is intended for the collection and transportation of malc 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.

#### 2.5 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 rcsults. The Abbott m2000sp is used for processing samples and the Abbott m2000rt is used for amplification and detection.

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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.

#### 2.6 Background on Chlamydial and Gonorrheal Disease

Chlamydia are non-motile, Gram-negative, obligate intracellular parasites of eukaryotic cells. They form inclusions in the cytoplasm of the host cell. Chlamydia trachomatis, one of three chlamydial species, is the causative agent of the sexually transmitted disease (STD) chlamydia. Chlamydial infections of the urogenital tract are associated with salpingitis, ectopic pregnancies and tubal factor infertility in women as well as nongonococcal urethritis and epididymitis in men. 13. The genital site most commonly affected in women is the ccrvix, but the infection can be asymptomatic and, if untreated, is likely to ascend to the uterus, fallopian tubes and ovaries causing pelvic inflammatory disease (PID).4 Neonates born of infected mothers can contract inclusion conjunctivitis. nasopharyngeal infections, and pneumonia due to Chlamydia trachomatis.5 Infection by Chlamydia trachomatis in men is also often asymptomatic and, if untreated, may lead to epididymitis, a major complication.3 Patients infected with Chlamydia trachomatis may be co-infected with Neisseria gonorrhoeae, the causative agent of gonorrhea. Further, patients with treatment indications for gonorrhea but not chlamydia often harbor Chlamydia trachomatis. Chlamydia infections may not respond well to recommended regimens for treating Neisseria gonorrhoeae. Therefore, unless chlamydial infection has

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been ruled out in patients treated for gonorrhea, dual therapy for gonococcal and chlamydial infections is recommended.7

Cell culture, commonly used to detect Chlamydia trachomatis, has been replaced by more sensitive nucleic acid tests.8 Since a specific diagnosis of chlamydia may improve treatment compliance and cnhance partner notification, the use of these highly sensitive and specific tests is strongly recommended.7

Gonorrhea is one of the most common sexually transmitted diseases in the United States. Over 700,000 new infections of Neisseria gonorrhoeue are estimated to occur each year." In men, gonorthea infection usually results in acute anterior urethritis accompanied by a purulent exudate. "0.1 In women, the infection is most often found in the cervix, but the vagina and uterus also may be infected. Frequently the infection is asymptomatic. especially in women. Without treatment, local complications of gonococcal infection can occur including pelvic inflammatory disease (PID) or acute salpingitis for women and epididymitis for men.1011 Rarcly, disseminated gonococcal infection, DGI, may occur in untreated patients.13

Neisseria gonorrhoeae is a Gram-negative, oxidase-positive diplococcus without flagellae.12 Culture is commonly used for the detection of Neisseria gonorrhoeae. Presumptive diagnosis of gonorrhea is based on the morphological examination, Gram stain, and oxidase measurement of the culture isolate. Confirmation proccdures have been used for definitive identification of Neisseria gonorrhoeae including sugar fermentation, fluorescent antibody staining, nucleic acid hybridization, and agglutination.'4.15 Nucleic acid tests are widely available for the sensitive detection of Neisseria gonorrhoeae.

## 2.7 Technological Characteristics of the Device as Compared to the Predicate

The primary functional components of the Abbott RealTime CT/NG assay are substantially equivalent to other legally marketed nucleic acid amplification tests (NAAT) intended for the qualitative detection of Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (NG).

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The Abbott RealTime CT/NG assay has the same general intended uses as the predicate devices. Although there are some technological differences between the Abbott RealTime CT/NG and the predicate devices, these differences do not raise new types of safety or effectiveness questions.

These devices are similar in that they are designed to prepare nucleic acids for amplification, amplify specific Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (NG) sequences, detect the amplified products, and report qualitative results.

The primary similarities and differences between the Abbott RealTime CT/NG assay and the NAAT predicate devices are shown in Table 2.1.

The primary functional components of the Abbott multi-CollectSpecimen Collection Kit are substantially equivalent to other legally marketed devices intended for the collection and transportation of clinical specimens for the direct, qualitative detection of Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (NG).

The Abbott multi-Collect Specimen Collection Kit has the same general intended use as the predicate devices. Although there are some technological differences between the Abbott multi-Collect Specimen Collection Kit and the prodicate devices, these differences do not raise new types of safety or effectiveness questions.

These devices are similar in that they are designed to collect urogenital specimens and to stabilize the nucleic acid of the specimen during transport and storage prior to nucleic acid testing.

The primary similarities and differences between the Abbott multi-Collect Specimen Collection Kit and the predicate devices are shown in Tables 2.2 through 2.4.

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| | Current Application | Amplified Nucleic Acid Predicate Devices | |
|------------------------------------|---------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------|
| Feature | Abbott RealTime CT/NG | Gen-Probe Aptima Combo 2 | Becton Dickenson ProbeTec ET |
| Assay Type | Qualitative • | Qualitative • | Qualitative • |
| CT Analyte<br>Targets | CT cryptic plasmid<br>DNA • | CT ribosomal RNA • | CT cryptic plasmid DNA • |
| NG Analyte<br>Targets | NG genomic DNA • | NG ribosomal RNA • | NG genomic DNA • |
| Input Sample<br>Types | Self-collected vaginal<br>swab specimens • | Endocervical swab specimens •<br>Self-collected vaginal swab<br>specimens •<br>Clinician-collected vaginal swab<br>specimens • | Endocervical swab specimens •<br>Male urethral swab specimens •<br>Male and female urine specimens • |
| | Clinician-collected<br>vaginal swab<br>specimens •<br>Male urethral swab<br>specimens •<br>Male and female urine<br>specimens • | PreservCyt liquid Pap specimens •<br>Male urethral swab specimens •<br>Male and female urine specimens. • | |
| Sample<br>Preparation<br>Procedure | Automated • | Semi-automated/automated • | Manual/ semi-automated • |
| Amplification<br>Technology | Real-time PCR • | TMA • | SDA • |
| Assay Controls | Negative Control •<br>Cutoff Control •<br>Internal Control • | Negative Control •<br>Positive Control • | Negative Control •<br>Positive Control • |

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## Similarities and Differences between Abbott multi-Collect Specimen Collection Kit and the Predicate Devices (Urine Specimen Collection) ・・

| | Current Application | Predicate Devices for Urine Specimens | |
|--------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Feature | Abbott multi-Collect<br>Specimen Collection Kit | Gen-Probe Aptima<br>Urine Specimen Collection Kit | BDProbeTec<br>Urine Processing Kit |
| Device Description | Contains a transfer pipette for adding<br>approximately 3.0 mL of urine to the<br>Transport Tube. The Transport Tube<br>contains 1.2 mL of Specimen Transport<br>Buffer and is used to stabilize DNA until<br>sample preparation. | Contains a disposable transfer<br>pipette for adding approximately 2<br>mL of urine to a Specimen<br>Transport Tube containing<br>2.0 mL of Transport Buffer. | Contains a disposable transfer<br>pipette for adding approximately<br>2.5 to 3.5 mL of urine to one<br>Urine Preservative Transport or<br>Urine Processing Pouch. |

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| | Current Application | Predicate Device for Male Urethral Swab Specimens |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Table 2.3<br>Similarities and Differences between Abbott multi-Collect Specimen Collection Kit and the Predicate Devices<br>(Urethral Swab Specimen Collection) | | |
| | | Gen-Probe Aptima Unisex Swab<br>Specimen Collection Kit for |
| Feature | Abbott multi-Collect Specimen Collection Kit | Endocervical and Male Urethral<br>Swab Specimens |
| Device Description | Contains an individually packaged sterile Specimen<br>Collection Swab that is placed into the Transport<br>Tube after swab sampling. The Transport Tube<br>contains 1.2 mL of Specimen Transport Buffer and<br>is used to stabilize DNA until sample preparation. | Contains an individually packaged sterile Endocervical<br>Cleaning Swab and an individually packaged sterile<br>Specimen Collection Swab that is placed into the<br>Transport Tube after swab sampling. The Transport<br>Tube contains 2.9 mL of Specimen Transport Buffer<br>and is used to stabilize DNA until sample preparation.<br>The Gen-Probe Aptima Unisex Swab Specimen<br>Collection Kit can be used to collect either<br>Endocervical or Male Urethral Swab specimens. |

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# Table 2.4 Similarities and Differences between Abbott multi-Collect Specimen Collection Kit and the Predicate Devices (Vaginal Swab Specimen Collection)

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

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### 2.8 Summary of Nonclinical Studies

## 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 m2000 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 CTNG assay targets the Chlamydia cryptic plasmid (present at approximately 7 to 10 copies per Chlumydia organism) and the multicopy opacity gene of Neisseria gonorrhoeae (repeated up to 11 times per organism). Thus, 320 copics 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 sample 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).

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.

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Serovars A through K, L1, and L2 were detected at less than 1 Inclusion Forming Units (IFU) per assay and scrovar 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 cach isolate. All isolates were detected at less than I Colony Forming Unit (CFU)/assay.

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## 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 2.5). These included organisms that are phylogenctically 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 x 10' copies/assay. HBV DNA and HCV RNA were added directly into the PCR reaction at approximately 3 x 105 and 9 x 106 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. Thesc included 27 organisms listed in Table 7.5, 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 wcre tested at 105 cells per assay, C. pneumoniae and C. psittaci were tested at 10° EB per assay. HSV-1 and HSV-2 were tested at 106 genomes per assay, and the rest of the organisms were tested at 106 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 enterica | | |
| Bacteroides ureolyticus | Kingella denifricans | 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 hovis | | |
| 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<br>meningosepticum | Moraxella (Branhamella) catarrhalis | Streptomyces griseinus | | |
| Citrobacter freundii | Moraxella lacunata | Trichomonas vaginalis | | |
| Clostridium perfringens | 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 | | |

・

Table 2.5 Potentially Cross-Reactive Microorganisms/Viruses

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

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# Table 2.5 (Continued)

# Potentially Cross-Reactive Microorganisms/Viruses

| Microorganism/Virus | Microorganism/Virus |
|-------------------------|-------------------------------|
| Deinococcus radiodurans | Mycoplasma hominis |
| Derxia gummosa | Neisseria flava* |
| Eikenella corrodens | Neisseria meningitidis-A* |
| Enterobacter cloacae* | Neisseria meningitidis-B* |
| Enterobacter aerogenes | Neisseria meningitidis-C* |
| Enterococcus avium | Neisseria meningitidis-D* |
| Enterococcus faecalis* | Neisseria perflava* |
| Enterococcus faecium | Puntoea agglomerans |
| Escherichia coli* | Peptostreptococcus anaerobius |
| Fusobacterium nucleatum | Plesiomonas shigelloides |
| Gardnerella vaginalis | Propionibacterium acnes |
| Gemella haemolysans | Proteus mirabilis* |

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

・

Abbott RealTime CT/NG // multi-Collect Specimen Collection Kit March 2008
Soc 2 110(k) Summary_mw9

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# Evaluation of Potentially Interfering Substances

The potential for interference in the Abbott RealTime CT/NG assay was assessed with substances that may be found in swab and/or urine specimens. Substances were spiked into a swab and/or urinc matrix containing 320 copies of CT and NG target DNA per assay, and into a swab and/or urine matrix without CT or NG DNA.

No interference in the performance of the Abbott RealTime CT/NG assay was observed in the presence of the substances listed in Table 2.6.

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| Substance | Matrix | Highest Concentration Tested |
|----------------------------------------------------|----------------|------------------------------|
| Zovirax® Cream 5% | Swab | 0.25 |
| CLOTRIMAZOLE Vaginal Cream (2%) | Swab | 0.25% |
| Delfen® | Swab | 0.25% |
| KY® Jelly | Swab | 0.25% |
| Lubrin® | Swab | 0.25% |
| Metrogel-Vaginal® | Swab | 0.25% |
| Miconazole® 3 Suppository | Swab | 0.25% |
| Monostat-IT™ Dosc Treatment (tioconazole ointment) | Swab | 0.25% |
| Norforms® Deodorant Suppositories | Swab | 0.25% |
| Terazol-3® Vaginal Cream | Swab | 0.25% |
| Vagi gard® Povidone-Iodine Medicated Douche | Swab | 0.25% |
| Vagi gard® Moisturizing Gel | Swab | 0.25% |
| Vagisil® Anti-itch Creme | Swab | 0.25% |
| Vagisil® Intimate Lubricant | Swab | 0.25% |
| Yeast gard® | Swab | 0.25% |
| Bilirubin | Urinc | 10 mg/mL |
| Glucose | Urinc | 10 mg/mL |
| pH 4 (acidic) Urine | Urine | N/A |
| pH 9 (alkaline) Urine | Urine | N/A |
| Protein: BGG | Urine | 5% |
| Blood | Swab and Urine | 5% |
| Leukocytes | Swab and Urine | 1 x 10° cell/mL |

Table 2.6

Substances That Do Not Interfere with the Abbott RealTime CT/NG Assay

Interference in the performance of the Abbott RealTime CT/NG assay may be observed with the following substances:

- Talcum powder at concentrations greater than 0.1% in urine specimens. .
- Phenazopyridine hydrochloride (the active ingredient in URISTAT) at concentrations . greater than 3 mg/mL in urine specimens.
- Mucus at concentrations greater than 0.1% for urine specimens and 1% for swab . specimens.

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#### 2.9 Precision Study

A precision study was performed at three sites, two external and onc 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 pancl member. The study included three amplification reagent lots. Each site tested two amplification reagent lots. A variance components analysis for a nested model was performed on delta cycle (DC) values, and the results are summarized in Tables 2.7 and 2.8, respectively.

{18}------------------------------------------------

| Panel<br>Membera | No.<br>Testedb | No.<br>Positive | Mean<br>Delta<br>Cycle | Within-<br>Run<br>Component<br>SDc | Between-<br>Run<br>Component<br>SDc | Between-<br>Lot<br>Component<br>SDc | Between-<br>Site<br>Component<br>SDc | Total<br>SDc,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 | 3.12 | 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 | 0.637 | 0.000 | 0.192 | 0.000 | 0.665 |

| | | Table 2.7 | | | |
|--|--|-----------|--|--|--|
|--|--|-----------|--|--|--|

Precision Study: CT Results

2 CT concentrations were urgeted approximately to 4500 IFU/assay in members 1, 2, and 6 and to 45 IFU/assay in e of othermanent was argeted upproximately 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.

Invalid replicates were excluded from the unalysis.

& 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.

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

## Table 2.8

| Panel<br>Membera | No.<br>Testedb | No.<br>Positive | Mean<br>Delta<br>Cycle | Within-Run<br>Component<br>SDc | Between-<br>Run<br>Component<br>SDc | Between-<br>Lot<br>Component<br>SDc | Between-<br>Site<br>Component<br>SDc | Total<br>SDc,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 | ... | ... | ... | ... | ... | ... |
| 9 | 148 | 56 | 0.58 | 0.386 | 0.000 | 0.000 | 0.120 | 0.404 |

## Precision Study: NG Results

° NG concentrations were targeted approximately to 2000 CFU/assay in members I and 7; to 20 CFU/assay in nembers 2, 3, und 5. Member 9 was targeted to 0.1 CFU/assay, below the claimed assay LOD. Members 4, 6, and 8 did not contain any NG 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-148), including those beyond the assay cutoff, resulted in a total SD of 0.978.
4 The total variability contains within-run, between-lot, and between-site variability.

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

Abbott RcalTime CT/NG // multi-Collect Specimen Collection Kit March 2008 Sec 2 510(k) Summary_mus9

Volume I Section 2 Page 19

{19}------------------------------------------------

## Summary of Clinical Studies 2.10

Performance charactcristics 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 cmergency room. A total of 3,832 malc and female, asymptomatic and symptomatic subjects were enrolled. Study subjects were classified as symptomatic if the subject reported STD-related symptoms. Specimens collected from cach female subject included urine, endocervical swabs, selfcollected 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 reference NAATs reported negative results for all sample types. A male subject was categorized as not infected with CT or NG if a total of at least two negative results were reported by the reference NAATs.

{20}------------------------------------------------

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 determincd for 33 subjects for CT and 35 subjects for NG.

Tables 2.9 through 2.28 summarize the clinical trial data.

Abbott RealTime CT/NG // multi-Collect Sqecimen Collection Kit March 2008 Sec 2 510(k) Summary .cnw9

Volume I Section 2
Pagc 21

{21}------------------------------------------------

| Abbott RealTime CT/NG // multi-Collect Specimen Collection KitVo | | |
|------------------------------------------------------------------|--|--|
| March 2008 | | |
| Soc 2 510(k) Summary_mw9 | | |

| Arouning | 8 |
|----------|---|
| | |
| | |
| | |
| - | |

| ਤੇ<br>િત્વ | |
|------------|--|
| | |

| Female Specimens | | | | | | | | | |
|-------------------------------------|--------------|-----|----------|-----------|----------|-----------|------------------------|------------------------|--|
| Specimen | Symptoms | n | True Pos | False Pos | True Neg | False Neg | Sensitivity (95% C.I.) | Specificity (95% C.I.) | |
| Clinician-Collected<br>Vaginal Swab | Symptomatic | 732 | 74 | 8 | 644 | 6 | 92.5 (84.4, 97.2) | 99.8 (97.6, 99.5) | |
| Self-Collected<br>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) | |

# Table 2.9 Chlamydia trachomatis Clinical Sensitivity and Specificity
Female Specimens

{22}------------------------------------------------

| Specimen | Symptoms | n | True Pos | False Pos | True Neg | False Neg | Sensitivity (95% C.I.) | Specificity (95% C.I.) |
|------------------|--------------|-----|----------|-----------|----------|-----------|------------------------|------------------------|
| Urethral<br>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) |

.

\$\frac{8}{3}\$

ຽງ ແຜ່ນວັລ
ປີ ແລະມວລຽ

{23}------------------------------------------------

/s

| Specimen | Symptoms |
|-----------------------------------------|-------------|
| Clinician-<br>Collected<br>Vaginal Swab | Symptomatic |
| Self-<br>Collected<br>Vaginal Swab | Symptomatic |
| Urine | Symptomatic |

# Table 2.11 Neisseria gonorrhoeae Clinical Sensitivity and Specificity Female Specimens

| | Symptoms | n | True<br>Pos | False<br>Pos | True<br>Neg | False<br>Neg | Sensitivity (95% C.I.) | Specificity (95% C.I.) |
|--|--------------|-----|-------------|--------------|-------------|--------------|------------------------|------------------------|
| | Symptomatic | 733 | 30 | 1 | 701 | 1 | 96.8 (83.3, 99.9) | 99.9 (99.2, 100.0) |
| | Symptomatic | 700 | 29 | 2 | 688 | 1 | 96.7 (82.8, 99.9) | 99.7 (98.9, 100.0) |
| | 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) |

{24}------------------------------------------------

| 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) |

.

1 อัตรา 1 อัลบี 1 เมตร 1 เมตร 1 เมตร 2 เวลา 1

.
6

{25}------------------------------------------------

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

Table 2.13 1 < ificity by Clinical Tacting Site : 43- ----

ວຽງຈາກບາງວຽງ

{26}------------------------------------------------

| | CT Clinical Sensitivity and Specificity by Clinical Testing Site | | | | | | | |
|--------------------------|------------------------------------------------------------------|------|-------------|--------------|-------------|--------------|------------------------|------------------------|
| Specimen | Testing<br>Site | n | True<br>Pos | False<br>Pos | True<br>Neg | False<br>Neg | Sensitivity (95% C.I.) | Specificity (95% C.I.) |
| Male<br>Urethral<br>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<br>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) |

Table 2.13 (Continued)

​ປະ​ທາ​ລາ​ວ​ສິ​​ສ​ລັງ​
ປະ​ທາ​ລະ​ສັກ​ສາ​ລັດ​ນາ​ລະ​ດັບ​ ​
​

{27}------------------------------------------------

| 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-<br>Collected<br>Vaginal<br>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-<br>Collected<br>Vaginal<br>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<br>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) | | | |

:

Table 2.14 a c ーベーストー הים חומ G ﻟﻤﺸﺎﺭﻛﺔ ﻣ CHILLE CALL

:

ວການໄປ Virgin ແລະເປວົ ແລະແມ່ລະດຽວ 22 ເວລາໄດ້ - international 2002 ປີ 2010 ປີ 10:10
ປີ 2011 ປີ 2011 ປີ 11:11 ຊອງປີ 2011 ປີ 11:10 ຊຶມ 2017 ປີ 2017 ປີ 2017 ປີ 2017 ປີ 2017 ປີ 20

l

ປີ ແລ່ນວັນ ປີ 2008 ປີ 2008 ປີ 2000 ປີ 2000 ປີ 2000 ປີ 2000 ປີ 2000 ປີ 2000 ປີ 2000 ປີ 2000 ປີ 2000 ປີ 2000 ປີ 2000 ປີ 2000 ປີ 2000 ປີ 2000 ປີ 2000 ປີ 2000 ປີ 2000 ປີ 2000 ປີ

{28}------------------------------------------------

| NG Clinical Sensitivity and Specificity by Clinical Testing Site | | | | | | | | | | |
|------------------------------------------------------------------|-----------------|------|-------------|--------------|-------------|--------------|------------------------|------------------------|--|--|
| Specimen | Testing<br>Site | n | True<br>Pos | False<br>Pos | True<br>Neg | False<br>Neg | Sensitivity (95% C.I.) | Specificity (95% C.I.) | | |
| Male<br>Urethral<br>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<br>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) | | |

Table 2.14 (Continued)

{29}------------------------------------------------

| NAAT 1 | | | NAAT 2 | | | RealTime CT/NG | | | No. of Subjects | | |
|--------|-----|----|--------|----|-----|----------------|----|----------------------------|------------------------------|-------|--|
| E | CCV | FU | E | FU | CCV | SCV | FU | Symptomatic<br>(SCV/CCV/U) | Asymptomatic<br>(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 | |

# CT Analysis According to Patient Infected Status INFECTED FEMALE Subjects

E = Endocervical Swab Specimen; CCV = Clinician-Collected Vaginal Swab Specimen; FU = Female Urine Specimen; SCV = Self-Collected Vaginal Swab Specimen; U = Urine.

{30}------------------------------------------------

#### NAAT 1 NAAT 2 RealTime CT/NG No. of Subjects Symptomatic Asymptomatic 区 CCV FU D FU CCV SCV FU (SCV/CCV/U) (Urine Only) Total --ー ー 1. - 224 528 1052 ---u -NA ﺴ -રેરે 33 88 --ﺖ ﺳﮯ -NA --NA 2 l 3 ー NA NA 2 l 3 --ー ---2 l 3 ---NA NA --1 : --l 0 一 -NA NA ー NA NA 9 ·28 37 ー ・・ -ー --l -NA 0 l --। NA ---l l -NA -NA ー NA 0 --NA ー ----0 l l 2 ー NA 1 l ---0 2 NA ----NA 0 l l l --7 ﺖ ﺳ --— 2 9 NA -17 ------NA --30 47 7 -NA -6 । उ -ー --ー --3 2 5 ----NA NA ---NA l 2 ? --NA 2 ー -ー --NA NA ー 11 13 ---+ -l 2 3 l l --ー NA キ l 0 --+ ---5 0 5 ----+ 0 l l -NA = -------+ -NA l 0 l t --2 -----0 2 --+ --NA NA l 0 l — 3 5 -+ ー --ー -2 ---+ ---NA -0 l l + -— ---ﺖ 2 2 4 -+ 0 + ------2 2

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

E = Endocervical Swab Specimen; CCV = Clinician-Collected Vaginal Swab Specimen; FU = Female Urine Specimen; SCV = Self-Collected Vaginal Swab Specimen; U = Urine.

{31}------------------------------------------------

# Table 2.16 (Continued)

## CT Analysis According to Patient Infected Status NON-INFECTED FEMALE Subjects T ﻧﮯ ﻣﯿﮟ ﻣﯿﮟ ﻣ -

| | NAAT 1 | | | NAAT 2 | | RealTime CT/NG | | | No. of Subjects | | |
|--|--------|-----|----|--------|----|----------------|-----|----|----------------------------|------------------------------|-------|
| | E | CCV | FU | E | FU | CCV | SCV | FU | Symptomatic<br>(SCV/CCV/U) | Asymptomatic<br>(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.

T

{32}------------------------------------------------

| NAAT 1 | | NAAT 2 | RealTime CT/NG | | No. of Subjects | | |
|--------|----|--------|----------------|----|----------------------------|------------------------------|-------|
| MUS | MU | MU | MUS | MU | Symptomatic<br>(SCV/CCV/U) | Asymptomatic<br>(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 |

# CT Analysis According to Patient Infected Status INFECTED MALE Subjects

MUS = Male Urcthral Swab Specimen; MU = Male Urine Specimen; U = Urine.

{33}------------------------------------------------

| NAAT 1 | | NAAT 2 | RealTime CT/NG | | No. of Subjects | | |
|--------|----|--------|----------------|----|----------------------------|------------------------------|-------|
| MUS | MU | MU | MUS | MU | Symptomatic<br>(SCV/CCV/U) | Asymptomatic<br>(Urine Only) | Total |
| MUS | MU | MU | MUS | MU | 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 |
| + | - |…