(182 days)
Not Found
No
The device is a lateral-flow immunoassay, which is a traditional biochemical test. There is no mention of AI, ML, image processing, or any computational analysis of the results. The interpretation is based on the visual presence of a colored line.
No.
This device is a diagnostic tool designed to detect RSV antigens, not to treat or cure a condition.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is for the "detection of Respiratory Syncytial Virus (RSV) antigens," which is a diagnostic purpose.
No
The device description clearly outlines physical components like a Test Strip, plastic frame, Conjugate Tube, Sample Diluent, and plastic transfer pipettes, indicating it is a hardware-based immunoassay test kit, not software only.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it's for the "detection of Respiratory Syncytial Virus (RSV) antigens... in human nasal wash, nasopharyngeal aspirate, and nasal and nasopharyngeal swab samples." This involves testing samples taken from the human body to provide information about a person's health status (presence of RSV infection).
- Device Description: It describes a "lateral-flow immunoassay" that uses antibodies to detect specific antigens in a sample. This is a common method used in IVD tests.
- Performance Studies: The document details clinical studies where the device was tested against samples from symptomatic patients to evaluate its performance (sensitivity, specificity) in detecting RSV. This is a requirement for demonstrating the effectiveness of an IVD.
- Key Metrics: The document provides key metrics like sensitivity and specificity, which are standard performance indicators for IVD tests.
- Predicate Device: The mention of a "Predicate Device" (K041445; ImmunoCard STAT! RSV PLUS) indicates that this device is being compared to another legally marketed IVD for the same intended use.
All of these points align with the definition and characteristics of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
TRU RSV is a rapid, qualitative, lateral-flow immunoassay for the detection of Respiratory Syncytial Virus (RSV) antigens (fusion protein or nucleoprotein) in human nasal wash, nasopharyngeal aspirate, and nasal and nasopharyngeal swab samples. It is designed to test specimens from symptomatic patients aged 5 years or less. A negative result does not preclude RSV infection. It is recommended that all negative test results be confirmed by cell culture.
Product codes (comma separated list FDA assigned to the subject device)
GOG
Device Description
TRU RSV is distributed as a test kit that includes the following reagents:
- Test Strip: A test strip attached to a plastic frame or holder enclosed in a foil pouch with desiccant. The test strip carries monoclonal anti-RSV capture antibodies (to fusion proteins and nucleoproteins) f rhe test lines. The holder is used to stopper the Conjugate Tube. The paddle portion of the holder indicates where test and control lines should appear.
- pource conjugate consists of gold-conjugated anti-RSV (to fusion proteins and nucleoproteins), which serves as the detector antibodies.
- whilen served as the detected and buttered protein solution provided in a dropper vial. Sodium azide (0.094%) added as a preservative. Use as supplied.
- Plastic transfer pipettes with 50, 100, 200 and 300 µL volume marks.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
human nasal wash, nasopharyngeal aspirate, and nasal and nasopharyngeal swab samples.
Indicated Patient Age Range
patients aged 5 years or less
Intended User / Care Setting
TRU RSV is designed for use by laboratory professionals under the normal environmental conditions.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Clinical studies evaluated the performance of TRU RSV against tissue culture in the laboratory setting. Four independent laboratories in different geographic of the US and the manufacturer's laboratory tested r otal of 625 samples from symptomatic patients under 5 years of age and that had been submitted for RSV testing. Three hundred four of the samples were collected during the 2006-07 season and tested fresh, while 321 were tested as frozen/thawed samples. Frozen samples were collected during the 2006no and earlier seasons and tested by tissue culture before freezing. Samples were evenly distributed among male and female patients. Samples that produced different test results in TRU RSV than in tissue culture were tested by direct specimen fluorescence assay (DSFA) or by a polymerase chain reaction (PCR) assay. Those found to be RSV positive by DSFA or PCR are indicated in the postscripts to the tables below.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Study Objective: A cinical/field study was conducted to demonstrate that TRU RSV was substantially equivalent in performance to the standard reference method - tissue culture - in a clinical laboratory setting using i samples submitted for RSV testing.
Study Type: Clinical/field trials, Reproducibility evaluation, Analytical sensitivity, Assay specificity, Tests for interfering substances.
Sample Size: A total of 625 samples were tested in the clinical/field study. The reproducibility study involved 10 samples tested multiple times.
Key Results:
Fresh Wash/Aspirate (Total)
Sensitivity: 64/72 (88.9%)
Specificity: 90/111 (81.1%)
Correlation: 154/183 (84.2%)
Frozen Wash/Aspirate (Total)
Sensitivity: 79/88 (89.8%)
Specificity: 149/161 (92.5%)
Correlation: 228/249 (91.6%)
Fresh Swab (Total)
Sensitivity: 12/13 (92.3%)
Specificity: 100/107 (93.5%)
Correlation: 112/120 (93.3%)
Frozen Swab (Total)
Sensitivity: 33/46 (71.7%)
Specificity: 25/26 (96.2%)
Correlation: 58/72 (80.6%)
Reproducibility: The reproducibility evaluation assessed 10 samples (high positive, low positive, high negative, low negative) across three sites over three days with two runs per day.
Qual. Result:
HP (high positive) samples (5.5) consistently showed positive results (intensity 2 to 6).
LP (low positive) samples (1.5) showed positive results and varied in intensity (1 to 4).
HN (high negative) and LN (low negative) samples (0) consistently showed negative results (intensity 0).
Overall correlation of cut-off specimens was 100%.
Analytical Sensitivity:
Limit of Detection (TCID50/mL) for various RSV strains:
VR-26 (A): 2.49 x 10^2
VR-1302 (A): 4.47
VR-1540 (A): 5.52 x 10^1
VR-955 (B): 4.47
VR-1400 (B): 1.10 x 10^1
VR-1401 (B): 2.47
Assay Specificity: None of the bacterial, viral, or yeast strains tested (including Adenovirus, Coxsackie, Coronavirus, Cytomegalovirus, Influenza, Human metapneumovirus, Measles, Parainfluenza, Rhinovirus, and various bacteria and fungi) yielded a positive result in RSV-negative samples or interfered with detection of RSV-positive samples. An Epstein Barr virus clinical sample was also nonreactive.
Interfering Substances: Acetaminophen, Acetylsalicylic acid, Albuterol, Halls® Throat Drops, Ludens® Throat Drops, Clemastine fumarate, Diphenhydramine HCl, Dextromethorphan, Naproxen sodium, Phenylephrine hydrochloride, Oxymetazoline, Guaifenesin, Pseudoephedrine HCI, and Listerine® Mouthwash did not interfere at specified concentrations. Whole blood at concentrations greater than 2.9% and Chlorpheniramine maleate at concentrations greater than 1.7 mg/mL may cause false-positive test results.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
See "Summary of Performance Studies"
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
ImmunoCard STAT! RSV PLUS (K041445)
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 866.3405 Poliovirus serological reagents.
(a)
Identification. Poliovirus serological reagents are devices that consist of antigens and antisera used in serological tests to identify antibodies to poliovirus in serum. Additionally, some of these reagents consist of poliovirus antisera conjugated with a fluorescent dye (immunofluorescent reagents) used to identify polioviruses from clinical specimens or from tissue culture isolates derived from clinical specimens. The identification aids in the diagnosis of poliomyelitis (polio) and provides epidemiological information on this disease. Poliomyelitis is an acute infectious disease which in its serious form affects the central nervous system resulting in atrophy (wasting away) of groups of muscles, ending in contraction and permanent deformity.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 866.9.
0
Meridian Bioscience, Inc. Cincinnati. OH
510(k) Premarket Notification TRU RSV
SUMMARY OF SAFETY AND EFFECTIVENESS
IDENTIFICATION INFORMATION
SUBMITTER'S INFORMATION
OCT 1 8 2007
This summary of 510(k) safety and effectiveness is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.20.
SUBMITTER'S NAME AND ADDRESS: Meridian Bioscience, Inc. 3471 River Hills Drive Cincinnati, OH 45244
PHONE NUMBER: (513) 271-3700
FAX NUMBER: (513) 272-5213
CONTACT PERSON: Susan Rolih Official Correspondent
DATE SUMMARY PREPARED: September 27, 2007
TRADE NAME: TRU RSV
COMMON NAME: Rapid, qualitative lateral-flow immunoassay for the detection of Respiratory Syncytial Virus antigens.
CLASSIFICATION NAME: Antigen, CF (including CF control), Respiratory Syncytial Virus
REGULATION: 866.3480
INTENDED USES:
TRU RSV is a rapid, qualitative, lateral-flow immunoassay for the detection of Respiratory Syncytial Virus (RSV) antigens (fusion protein or nucleoprotein) in human nasal wash, nasopharyngeal aspirate, and nasal and nasopharyngeal swab samples. It is designed to test specimens from symptomatic patients aged 5 years or less. A negative result does not preclude RSV infection. It is recommended that all negative test results be confirmed by cell culture.
PREDICATE DEVICE:
TRU RSV is a modification of, and is intended to detect the same analytes as, ImmunoCard STAT! RSV PLUS (K041445), manufactured by Meridian Bioscience, Inc.
BACKGROUND:
Respiratory Syncytial Virus (RSV) is the most important cause of pneumonia and bronchiolitis in infants and small children. Approximately 90,000 children are hospitalized each year due to RSV in the USA alone. Hospitalization due to RSV is more frequently associated with children that have underlying disease or premature birth. Mortality rates are estimated to be between 1 and 3% for children that are hospitalized with RSV. RSV is also being recognized more frequently as a cause of significant respiratory disease in the elderly. RSV causes a wide range of respiratory symptoms that can be difficult to distinguish clinically from symptoms caused by other respiratory viruses such as influenza. Because of its high infectivity, the potential for prolonged patient shedding and the ability of the virus to survive for hours on environmental surfaces, RSV has emerged as a serious cause of nosocomial infection. RSV can be detected in human respiratory samples by a variety of methods including, immunofluorescent assay and enzyme immunoassay. Although is still considered the diagnostic test standard, it requires facilities and may take a week to complete. Immunofluorescent antibodybased tests are reasonably sensitive, yet highly dependent on specimen quality and preparation. Enzyme and microparticle-based immunoassays have become one the most frequently used methods for the detection of
1
Meridian Bioscience, Inc. Cincinnati, OH
RSV. TRU RSV is a lateral flow-based immunoassay for the rapid detection of RSV in human respiratory റ്റാ . TRO Nov is a faceral now basod in minenedom for the patient's clinical evaluation and assist the physician in determining a course of action.
Type of test
TRU RSV is a rapid, single-use, qualitative lateral-flow immunoassay screening test.
Specimen type
The following specimens have been found compatible with TRU RSV.
-
- Nasal wash
-
- Nasopharyngeal aspirate
- Nasopharyngeal swab റ്റ്
-
- Nasal swab
Conditions for use
TRU RSV is designed for use by laboratory professionals under the normal environmental conditions. The TNO NOV is occagince for doo by laboratory procession (20-25 C) to perform testing. Normal laboratory lighting, humidity and temperature do not affect the performance of the assay.
Contraindications
There are no contraindications associated with the use of this product.
Special instrument requirements
No instruments are used with this product.
Combination with other medical devices
No other medical devices are used in combination with this device.
2
Table 1. Comparison charts TRU RSV vs Predicate Device.
| Characteristics | TRU RSV | ImmunoCard STAT! RSV PLUS (predicate) |
|---|---|---|
| Device Type | ||
| Technology | Single use, rapid, lateral flow | |
| immunoassay | Single use, rapid, lateral flow | |
| immunoassay | ||
| In vitro diagnostic device | Yes | Yes |
| Control | Excludes external control reagent (purchased separately) | Excludes external control reagent |
| (purchased separately) | ||
| Calibrator | No | No |
| Intended Use | ||
| Detection of RSV antigen | Yes | Yes |
| Screening test | No | No |
| Diagnostic test | Yes | Yes |
| Identification test | No | No |
| Monitoring therapy | No | No |
| Acceptable Samples | ||
| Swab -- Nasal | Yes | Yes |
| Swab -- Nasopharyngeal | Yes | Yes |
| Wash -- Nasal | Yes | Yes |
| Aspirate -- Nasopharyngeal | Yes | Yes |
| Reagents/Components Provided | ||
| Nitrocellulose test strip | Yes (attached to plastic holder/tube closure) | Yes (enclosed in plastic frame) |
| Conjugate reagent | Yes (supplied as dried bead in | |
| Conjugate Tube) | Yes (supplied in conjugate pad attached to test strip) | |
| Reading Guide | Yes (part of plastic holder/tube closure) | Yes (part of plastic frame) |
| Sample Diluent/Negative Control (external) | Yes | Yes |
| Internal procedural control | Yes | Yes |
| External positive control | No (purchased separately) | No (purchased separately) |
| Source of RSV antibodies | Capture: Murine monoclonal anti-RSV (antibodies to fusion protein and nucleoprotein) | Capture: Murine monoclonal anti- |
| RSV (antibodies to fusion protein | ||
| and nucleoprotein) | ||
| Detector: Murine monoclonal anti-RSV (antibodies to fusion protein and nucleoprotein) | Detector: Murine monoclonal anti- | |
| RSV (antibodies to fusion protein | ||
| and nucleoprotein) | ||
| TRU RSV | ImmunoCard STAT! RSV PLUS | |
| (Predicate) | ||
| Comparison of | ||
| assay steps* | ||
| Technology | Lateral-flow, colloidal gold-based immunoassay | Lateral-flow, colloidal gold-based immunoassay |
| Test Reagents | 1. Test Strip (nitrocellulose membrane with immobilized capture antibody). | |
| Top end is inserted into plastic frame or holder. |
- Conjugate Tube containing antibody- colloidal gold conjugate (lyophilized bead)
- Sample Diluent/Negative Control | 1. Test Device (Test Card with nitrocellulose membrane with immobilized capture antibody, conjugate pad with colloidal gold particle-linked detector antibody, plastic frame with reading/reaction window and sample port).
- Sample Diluent/Negative Control |
| | External Positive Control sold separately as adjunct reagent | External Positive Control sold separately as adjunct reagent. |
| Specimen Type | 1. Nasal wash - Nasopharyngeal aspirate
- Nasal swabs
- Nasopharyngeal swabs | 1. Nasal wash
- Nasopharyngeal aspirate
- Nasal swabs
- Nasopharyngeal swabs |
| Equipment Required | No | No |
| Level of skill required | Complexity: Moderate | Complexity: CLIA Waived |
| Assay steps | 1. Add 100 µL Sample Diluent to the Conjugate Tube. - Add 100 µl sample to the Conjugate Tube and mix.
- Insert Test Strip to Conjugate Tube.
- Press down on cap of Test Strip to seal Conjugate Tube.
- Incubate 15 min, 20-25 С.
- Read at end of incubation using guide on holder. | 1. Add 4 drops Sample Diluent to a test tube.
- Add 150 µL sample and mix.
- Add 150 µL diluted specimen to Test Device.
- Incubate 15 min, 20-25 С.
- Read at end of incubation using guide at reaction window. |
| End point | Read at end of incubation using guide on holder.
Appearance of pink-red color at Test and/or Control lines | Appearance of pink-red color at Test and/or Control lines |
| Interpretation of test
result | RSV Positive = appearance of pink-red lines at Test and Control Line positions
(indicates presence of RSV antigens)
Negative = no test line color with pink-red Control Line (indicates absence of RSV antigens) | RSV Positive = appearance of pink-red lines at Test and Control Line positions
(indicates presence of RSV antigens)
Negative = no test line color with pink-red Control Line (indicates absence of RSV antigens) |
3
Table 2. Comparison of TRU RSV method to predicate
Note: Differences are underlined to facilitate their detection
4
DEVICE DESCRIPTION AND TECHNOLOGICAL PRINCIPLES
Reagents
TRU RSV is distributed as a test kit that includes the following reagents:
-
- Test Strip: A test strip attached to a plastic frame or holder enclosed in a foil pouch with desiccant. The test strip carries monoclonal anti-RSV capture antibodies (to fusion proteins and nucleoproteins) f rhe test lines. The holder is used to stopper the Conjugate Tube. The paddle portion of the holder indicates where test and control lines should appear.
- indoctor whole to the entraining a conjugate bead. The tube is enclosed in a foil 2. pource conjugate consists of gold-conjugated anti-RSV (to fusion proteins and nucleoproteins), which serves as the detector antibodies.
- whilen served as the detected and buttered protein solution provided in a dropper vial. Sodium 3. azide (0.094%) added as a preservative. Use as supplied.
- Plastic transfer pipettes with 50, 100, 200 and 300 µL volume marks. 4.
Equipment needed to use the device
There is no equipment needed to use this device.
Interfering substances
Whole blood, at concentrations greater than 2.9% may interfere with the interpretation of test results. Chloroheniramine maleate at concentrations greater than 1.7 mg/mL may cause false-positive test results.
Calibrators
There are no calibrators used with this device.
Controls
The assay includes an internal procedural CONTROL line that is used to determine if the test has been performed correctly, proper flow occurred and that reagents were reactive at the time of use. A clean background around the RSV TEST and CONTROL lines also serves as a procedural control. Control or test lines that are obscured by a heavy background color may invalidate the test and may be an indication of reagent deterioration, use of an inappropriate sample or improper test performance.
Positive Control Reagent is supplied separately. It is used in parallel with Sample Diluent/Negative Control as external controls. These reagents also serve as indicators that the test was performed correctly, that the capture and detector antibodies were active at the time of use, and that the membrane supports proper sample flow.
Failure of the internal and external controls to produce the expected results suggests the test was not performed correctly (ie, incorrect volume of reagents added; incorrect incubation temperature or times used or that reagents were not brought to room temperature prior to testing).
Technological principles
TRU RSV is a single use capture immunoassay to detection RSV in human samples. The test consists of a Conjugate Tube, a Test Strip and Sample Diluent. The Conjugate Tube contains a lyophilized bead of colloidal gold-linked monoclonal antibodies to RSV fusion protein and nucleoprotein (detector antibodies). The Test Strip carries a nitrocellulose membrane with dried capture antibodies placed at a designated Test Line for RSV. The Test Strip holder caps the Conjugate Tube during testing and subsequent disposal to reduce exposure to potential pathogens.
The conjugate bead is first rehydrated in the Conjugate Tube with Sample is then added, the contents mixed and the Test Strip added. If RSV antigens are present, they first bind to the monoclonal antibody-colloidal gold conjugate. When the sample migrates up the Test Strip to the Test Line, the antigen-conjugate complex is bound to the capture antibody, yielding a pink-red line. When no
5
Meridian Bioscience, Inc. Cincinnati, OH
antigen is present, no complexes are formed and no pink-red line appears at the Test Line. An internal antigen is proson, no completer adequate flow has occurred through the Test Strip during a test run. ourition line hope une at the Control position of the Test Strip should be present each time a specimen or control is tested. If no pink-red control line is seen, the test is considered invalid.
PERFORMANCE EVALUATION -- CLINICAL/FIELD TRIALS
Study Objective
A cinical/field study was conducted to demonstrate that TRU RSV was substantially equivalent in performance to the standard reference method - tissue culture - in a clinical laboratory setting using i samples submitted for RSV testing.
Investigational plan
Clinical studies evaluated the performance of TRU RSV against tissue culture in the laboratory setting. Four independent laboratories in different geographic of the US and the manufacturer's laboratory tested r otal of 625 samples from symptomatic patients under 5 years of age and that had been submitted for RSV testing. Three hundred four of the samples were collected during the 2006-07 season and tested fresh, while 321 were tested as frozen/thawed samples. Frozen samples were collected during the 2006no and earlier seasons and tested by tissue culture before freezing. Samples were evenly distributed among male and female patients. Samples that produced different test results in TRU RSV than in tissue culture were tested by direct specimen fluorescence assay (DSFA) or by a polymerase chain reaction (PCR) assay. Those found to be RSV positive by DSFA or PCR are indicated in the postscripts to the tables below.
Sample population and selection
The sample population used in this study included respiratory samples from patients 5 years or less provided the samples had been submitted for RSV testing. Such samples were assumed to be from symptomatic patients. The sample types included nasal wash, nasopharyngeal aspirate and throat, nasal and nasopharyngeal swabs.
Influence of other disease states
There is no influence by other disease states on test results.
Patient exclusion criteria
Samples from asymptomatic patients were excluded from the trials. Patients, whose specimens were submitted to the laboratory for RSV testing, were assumed to be symptomatic. There were no patient exclusion criteria with respect to medications or other therapies, age, or gender. The performance of TRU RSV was not established for patients greater than 5 years of age.
Clinical trial test svstem
Clinical trial sites employed full production lots of TRU RSV test kits. Tissue cultures were performed by each laboratory's established internal method. Three of the four independent laboratories completed reproducibility studies prior to testing patient samples. Reproducibility studies are described later in this section.
6
Clinical study data
Tables 3-5 provide an analysis of patient ages and sample type. Table 3 describes the types of samples tests and Table Tables 3-5 provide an analysis or patients from whom samples were collected during the study, and Table r able 4 loentifies the age groups of the patients from with summarize test outcomes for each site are given in Table 6.
| Table 3. Description of sample types evaluated in clinical studies | ||||
|---|---|---|---|---|
| -- | -- | -- | -- | -------------------------------------------------------------------- |
| Specimen Type | |||
|---|---|---|---|
| Wash/NPA | Swab | Total | |
| Total tested -- Clinical Site 1 | |||
| Total tested | 54 | 0 | 54 |
| Total fresh | 54 | 0 | 54 |
| Total frozen | 0 | 0 | 0 |
| Total tested -- Clinical Site 2 | |||
| Total tested | 10 | 27 | 37 |
| Total fresh | 5 | 24 | 29 |
| Total frozen | 5 | 3 | 8 |
| Total tested -- Clinical Site 3 | |||
| Total tested | 169 | 54 | 223 |
| Total fresh | 0 | 0 | 0 |
| Total frozen | 169 | 54 | 223 |
| Total tested -- Clinical Site 4 | |||
| Total tested | 200 | 55 | 255 |
| Total fresh | 125 | 40 | 165 |
| Total frozen | 75 | 15 | 90 |
| Total tested -- Clinical Site 5 | |||
| Total tested | 0 | 56 | 56 |
| Total fresh | 0 | 56 | 56 |
| Total frozen | 0 | 0 | 0 |
| Total tested -- All Sites | |||
| Total tested | 429 | 196 | 625 |
| Total fresh | 180 | 124 | 304 |
| Total frozen | 249 | 72 | 321 |
Legend: NPA = nasopharyngeal aspirate
7
| Patient Age | birth to 1
month | >1 month to 2
years | >2 years to 5
years | Total |
|----------------------|---------------------|------------------------|------------------------|-------|
| Clinical site 1 | | | | |
| Total tested | 11 | 37 | 6 | 54 |
| Clinical site 2 | | | | |
| Total tested | 0 | 36 | 1 | 37 |
| Clinical site 3 | | | | |
| Total tested | 39 | 169 | 15 | 223 |
| Clinical site 4 | | | | |
| Total tested | 57 | 168 | 30 | 255 |
| Clinical site 5 | | | | |
| Total tested | 1 | 31 | 24 | 56 |
| Clinical site Totals | | | | |
| Total tested | 108 | 441 | 76 | 625 |
Table 4. Categories of patients by age from who samples were collected for clinical studies
8
| Specimen Type | ||||
|---|---|---|---|---|
| Male | Female | Not defined | Total | |
| Clinical site 1 | ||||
| Total tested | 32 | 22 | 0 | 54 |
| Total TRU RSV positive | 10 | 11 | 0 | 21 |
| Total TRU RSV negative | 22 | 10 | 0 | 32 |
| Total invalid | 0 | 1 | 0 | 1 |
| Clinical site 2 | ||||
| Total tested | 21 | 16 | 0 | 37 |
| Total TRU RSV positive | 12 | 9 | 0 | 21 |
| Total TRU RSV negative | 9 | 7 | 0 | 16 |
| Total invalid | 0 | 0 | 0 | 0 |
| Clinical site 3 | ||||
| Total tested | 125 | 96 | 2 | 223 |
| Total TRU RSV positive | 48 | 28 | 2 | 78 |
| Total TRU RSV negative | 77 | 68 | 0 | 145 |
| Total invalid | 0 | 0 | 0 | 0 |
| Clinical site 4 | ||||
| Total tested | 139 | 116 | 0 | 255 |
| Total TRU RSV positive | 55 | 50 | 0 | 105 |
| Total TRU RSV negative | 84 | 66 | 0 | 150 |
| Total invalid | 0 | 0 | 0 | 0 |
| Clinical site 5 | ||||
| Total tested | 32 | 24 | 0 | 56 |
| Total TRU RSV positive | 1 | 3 | 0 | 4 |
| Total TRU RSV negative | 31 | 21 | 0 | 52 |
| Total invalid | 0 | 0 | 0 | 0 |
| Clinical site Totals | ||||
| Total tested | 349 | 274 | 2 | 625 |
| Total TRU RSV positive | 126 | 101 | 2 | 229 |
| Total TRU RSV negative | 223 | 172 | 0 | 395 |
| Total invalid | 0 | 1 | 0 | 1 |
Table 5. Classification of patients from whom samples were collected based on sex
9
:
Table 6. Summary --Distribution of TRU RSV results by sample type and by site
| Fresh Wash
| /Aspirate Site 1 | TRU RSV* | ||
|---|---|---|---|
| Tissue Culture | Positive | Negative | Total |
| Positive | 7 | 1 | 8 |
| Negative | 14 | 31 | 45 |
| Total | 21 | 32 | 53 |
| Sensitivity | 7/8 | 87.5% | 47.3 - 99.7% |
| Specificity | 31/45 | 68.9% | 53.4 - 81.8% |
| Correlation | 38/53 | 71.7% | 57.6 - 83.2% |
*1 TRU RSV Invalid
| Fresh Wash
| /Aspirate Site 2 | TRU RSV | ||
|---|---|---|---|
| Tissue Culture | Positive | Negative | Total |
| Positive | 3 | 0 | 3 |
| Negative | 0 | 2 | 2 |
| Total | 3 | 2 | 5 |
| % | |||
| Sensitivity | 3/3 | 100.0% | 29.2 - 100% |
| Specificity | 2/2 | 100.0% | 15.8 - 100% |
| Correlation | 5/5 | 100.0% | 47.8 - 100% |
| Fresh Wash
| /Aspirate Site 4 | TRU RSV | ||
|---|---|---|---|
| Tissue Culture | Positive | Negative | Total |
| Positive | 54 | 7 | 61 |
| Negative | 7 | 57 | 64 |
| Total | 61 | 64 | 125 |
| Sensitivity | 54/61 | 88.5% | 77.8 - 95.3% |
| Specificity | 57/64 | 89.1% | 78.8 - 95.5% |
| Correlation | 111/125 | 88.8% | 83.3 - 94.3% |
| Fresh Wash
| /Aspirate Total | TRU RSV* | ||
|---|---|---|---|
| Tissue Culture | Positive | Negative | Total |
| Positive | 64 | 8 | 72 |
| Negative | 21** | 90 | 111 |
| Total | 85 | 98 | 183 |
| Sensitivity | 64/72 | 88.9% | 79.3 - 95.1% |
| Specificity | 90/111 | 81.1% | 73.8 - 88.4% |
| Correlation | 154/183 | 84.2% | 78.9 - 89.4% |
*1 TRU RSV Invalid
** Of the 21 TRU RSV false-positive results, 3 were positive by DSFA.
10
| Frozen Wash
| /Aspirate Site 2 | TRU RSV | ||
|---|---|---|---|
| Tissue Culture | Positive | Negative | Total |
| Positive | 5 | 0 | 5 |
| Negative | 0 | 0 | 0 |
| Total | 5 | 0 | 5 |
| Sensitivity | 5/5 | 100.0% | 47.8 - 100% |
| Specificity | 0/0 | N/A | N/A |
| Correlation | 5/5 | 100.0% | 47.8 - 100% |
| Frozen Wash
| /Aspirate Site 3 | TRU RSV | ||
|---|---|---|---|
| Tissue Culture | Positive | Negative | Total |
| Positive | 40 | 7 | 47 |
| Negative | 10 | 112 | 122 |
| Total | 50 | 119 | 169 |
| Sensitivity | 40/47 | 85.1% | 71.7 - 93.8% |
| Specificity | 112/122 | 91.8% | 85.4 - 96.0% |
| Correlation | 152/169 | 89.9% | 85.4 - 94.5% |
| Frozen Wash | |||
| /Aspirate Site 4 | TRU RSV | ||
| Tissue Culture | Positive | Negative | Total |
| Positive | 34 | 2 | 36 |
| Negative | 2 | 37 | 39 |
| Total | 36 | 39 | 75 |
| Sensitivity | 34/36 | 94.4% | 81.3 - 99.3% |
| Specificity | 37/39 | 94.9% | 82.7 - 99.4% |
| Correlation | 71/75 | 94.7% | 86.9 - 98.5% |
| Frozen Wash
| /Aspirate Total | TRU RSV | ||
|---|---|---|---|
| Tissue Culture | Positive | Negative | Total |
| Positive | 79 | 9 | 88 |
| Negative | 12* | 149 | 161 |
| Total | 91 | 158 | 249 |
| Sensitivity | 79/88 | 89.8% | 81.5 - 95.2% |
| Specificity | 149/161 | 92.5% | 87.3 - 96.1% |
| Correlation | 228/249 | 91.6% | 87.4 - 94.7% |
- Of the 12 TRU RSV false-positive results, 2 were positive by DSFA.
:
11
| Fresh Swab
| Site 2 | TRU RSV | ||
|---|---|---|---|
| Tissue Culture | Positive | Negative | Total |
| Positive | 8 | 1 | 9 |
| Negative | 4 | 11 | 15 |
| Total | 12 | 12 | 24 |
| Sensitivity | 8/9 | 88.9% | 51.8 - 99.7% |
| Specificity | 11/15 | 73.3% | 44.9 - 92.2% |
| Correlation | 19/24 | 79.2% | 57.8 - 92.9% |
| Fresh Swab
| Site 4 | TRU RSV | ||
|---|---|---|---|
| Tissue Culture | Positive | Negative | Total |
| Positive | 3 | 0 | 3 |
| Negative | 0 | 37 | 37 |
| Total | 3 | 37 | 40 |
| Sensitivity | 3/3 | 100.0% | 29.2 - 100% |
| Specificity | 37/37 | 100.0% | 90.5 - 100% |
| Correlation | 40/40 | 100.0% | 91.2 - 100% |
| Fresh Swab | |||
| Site 5 | TRU RSV | ||
| Tissue Culture | Positive | Negative | Total |
| Positive | 1 | 0 | 1 |
| Negative | 3 | 52 | 55 |
| Total | 4 | 52 | 56 |
| Sensitivity | 1/1 | 100.0% | N/A |
| Specificity | 52/55 | 94.5% | 84.9 - 98.9% |
| Correlation | 53/56 | 94.6% | 85.1 - 98.9% |
| Fresh Swab
| Total | TRU RSV | ||
|---|---|---|---|
| Tissue Culture | Positive | Negative | Total |
| Positive | 12 | 1 | 13 |
| Negative | 7* | 100 | 107 |
| Total | 19 | 101 | 120 |
| Sensitivity | 12/13 | 92.3% | 64.0 - 99.8% |
| Specificity | 100/107 | 93.5% | 87.0 - 97.3% |
| Correlation | 112/120 | 93.3% | 87.3 - 97.1% |
- Of the 7 TRU RSV false-positive results, 4 were positive by PCR.
12
| Frozen Swab
| Site 2 | TRU RSV | ||
|---|---|---|---|
| Tissue Culture | Positive | Negative | Total |
| Positive | 1 | 0 | 1 |
| Negative | 0 | 2 | 2 |
| Total | 1 | 2 | 3 |
| Sensitivity | 1/1 | 100.0% | N/A |
| Specificity | 2/2 | 100.0% | 15.8 - 100% |
| Correlation | 3/3 | 100.0% | 29.2 - 100% |
| Frozen Swab
| Site 3 | TRU RSV | |||
|---|---|---|---|---|
| Tissue Culture | Positive | Negative | Total | |
| Positive | 27 | 12 | 39 | |
| Negative | 1 | 14 | 15 | |
| Total | 28 | 26 | 54 | |
| Sensitivity | 27/39 | 69.2% | 52.4 - 83.0% | |
| Specificity | 14/15 | 93.3% | 68.0 - 99.8% | |
| Correlation | 41/54 | 75.9% | 62.4 - 86.5% |
| Frozen Swab
| Site 4 | TRU RSV | ||
|---|---|---|---|
| Tissue Culture | Positive | Negative | Total |
| Positive | 5 | 1 | 6 |
| Negative | 0 | 9 | 9 |
| Total | 5 | 10 | 15 |
| Sensitivity | 5/6 | 83.3% | 56.5 - 84.0% |
| Specificity | 9/9 | 100.0% | 66.4 - 100% |
| Correlation | 14/15 | 93.3% | 68.0 - 99.8% |
| Frozen Swab
| Total | TRU RSV | ||
|---|---|---|---|
| Tissue Culture | Positive | Negative | Total |
| Positive | 33 | 13 | 46 |
| Negative | 1 | 25 | 26 |
| Total | 34 | 38 | 72 |
| Sensitivity | 33/46 | 71.7% | 56.5 - 84.0% |
| Specificity | 25/26 | 96.2% | 80.4 - 99.9% |
| Correlation | 58/72 | 80.6% | 69.5 - 88.9% |
NOTE: As the data above indicates, the performance characteristics generated from prospective frozen specimens might not be the same as the performance characteristics generated from prospective fresh specimens.
13
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evalle the econor in releving wand me one in Table , in of 4 intilly
| Site Number | Specimen # | Specimen Type | Fresh/ Frozen | TRU RSV Result | Culture Result | Additional or repeat Testing and comments |
|---|---|---|---|---|---|---|
| 1 | 3 | Nasal Wash | Fresh | Positive RSV | Negative RSV | |
| 1 | 8 | Nasal Wash | Fresh | Positive RSV | Negative RSV | |
| 1 | 10 | Nasal Wash | Fresh | Positive RSV | Negative RSV | |
| 1 | 14 | Nasal Wash | Fresh | Positive RSV | Negative RSV | |
| 1 | 15 | Nasal Wash | Fresh | Positive RSV | Negative RSV | |
| 1 | 17 | Nasal Wash | Fresh | Positive RSV | Negative RSV | |
| 1 | 18 | Nasal Wash | Fresh | Positive RSV | Negative RSV | |
| 1 | 20 | Nasal Wash | Fresh | Positive RSV | Negative RSV | |
| 1 | 26 | Nasal Wash | Fresh | Positive RSV | Negative RSV | |
| 1 | 27 | Nasal Wash | Fresh | Positive RSV | Negative RSV | |
| 1 | 30 | Nasal Wash | Fresh | Positive RSV | Negative RSV | |
| 1 | 35 | Nasal Wash | Fresh | Positive RSV | Negative RSV | |
| 1 | 38 | Nasal Wash | Fresh | Positive RSV | Negative RSV | |
| 1 | 47 | Nasal Wash | Fresh | Positive RSV | Negative RSV | |
| 4 | 78 | Nasal Wash | Fresh | Positive RSV | Negative RSV | DSFA negative |
| 4 | 82 | Nasal Wash | Fresh | Positive RSV | Negative RSV | DSFA Positive for RSV |
| 4 | 87 | Nasal Wash | Fresh | Positive RSV | Negative RSV | DSFA Positive for RSV |
| 4 | 188 | Nasal Wash | Fresh | Positive RSV | Negative RSV | DSFA Negative for RSV |
| 4 | 216 | Nasal Wash | Fresh | Positive RSV | Negative RSV | DSFA Negative |
| 4 | 217 | Nasal Wash | Fresh | Positive RSV | Negative RSV | DSFA Negative |
| 4 | 223 | Nasal Wash | Fresh | Positive RSV | Negative RSV | DSFA Positive for RSV |
| Site Number | Specimen # | Specimen Type | Fresh/ | |||
| Frozen | TRU RSV Result | Culture Result | Additional or repeat Testing and | |||
| comments | ||||||
| 3 | 40 | Nasal Wash | Frozen | Positive RSV | Negative RSV | |
| 3 | 62 | Nasal Wash | Frozen | Positive RSV | Negative RSV | |
| 3 | 125 | Nasal Wash | Frozen | Positive RSV | Negative RSV | |
| 3 | 137 | Nasal Wash | Frozen | Positive RSV | Negative RSV | |
| 3 | 178 | Nasal Wash | Frozen | Positive RSV | Negative RSV | |
| 3 | 192 | Nasal Wash | Frozen | Positive RSV | Negative RSV | |
| 3 | 195 | Nasal Wash | Frozen | Positive RSV | Negative RSV | |
| 3 | 249 | Nasal Wash | Frozen | Positive RSV | Negative RSV | |
| 3 | 264 | Nasal Wash | Frozen | Positive RSV | Negative RSV | |
| 3 | 266 | Nasal Wash | Frozen | Positive RSV | Negative RSV | |
| 4 | 117 | Nasal Wash | Frozen | Positive RSV | Negative RSV | DSFA Positive for RSV |
| 4 | 145 | Nasal Wash | Frozen | Positive RSV | Negative RSV | DSFA Positive for RSV |
| 2 | 40 | Nasal Swab | Fresh | Positive RSV | Negative RSV | PCR Positive for RSV |
| 2 | 6 | Nasopharyngeal Swab | Fresh | Positive RSV | Negative RSV | PCR Positive for RSV |
| 2 | 25 | Nasopharyngeal Swab | Fresh | Positive RSV | Negative RSV | PCR Positive for RSV |
| 2 | 38 | Nasopharyngeal Swab | Fresh | Positive RSV | Negative RSV | PCR Positive for RSV |
| 5 | 44 | Nasal Swab | Fresh | Positive RSV | Negative RSV | |
| 5 | 47 | Nasal Swab | Fresh | Positive RSV | Negative RSV | |
| 5 | 50 | Nasal Swab | Fresh | Positive RSV | Negative RSV | |
| 3 | 161 | Nasopharyngeal Swab | Frozen | Positive RSV | Negative RSV | |
| Site Number | Specimen # | Specimen Type | Fresh/Frozen | TRU RSV Result | Culture Result | Additional or repeat Testing and comments |
| 1 | 51 | Nasal Wash | Fresh | Negative RSV | Positive RSV | |
| 4 | 6 | Nasal Wash | Fresh | Negative RSV | Positive RSV | DSFA Positive for RSV |
| 4 | 24 | Nasal Wash | Fresh | Negative RSV | Positive RSV | DSFA Positive for RSV |
| 4 | 32 | Nasal Wash | Fresh | Negative RSV | Positive RSV | |
| 4 | 75 | Nasal Wash | Fresh | Negative RSV | Positive RSV | DSFA positive for RSV |
| 4 | 90 | Nasal Wash | Fresh | Negative RSV | Positive RSV | |
| 4 | 136 | Nasal Wash | Fresh | Negative RSV | Positive RSV | DSFA positive for RSV |
| 4 | 147 | Nasal Wash | Fresh | Negative RSV | Positive RSV | DSFA Positive for RSV |
| 3 | 7 | Nasal Wash | Frozen | Negative RSV | Positive RSV | |
| 3 | 9 | Nasal Wash | Frozen | Negative RSV | Positive RSV | |
| 3 | 12 | Nasal Wash | Frozen | Negative RSV | Positive RSV | |
| 3 | 42 | Nasal Wash | Frozen | Negative RSV | Positive RSV | |
| 3 | 52 | Nasal Wash | Frozen | Negative RSV | Positive RSV | |
| 3 | 56 | Nasal Wash | Frozen | Negative RSV | Positive RSV | |
| 3 | 197 | Nasopharyngeal Aspirate | Frozen | Negative RSV | Positive RSV | |
| 4 | 54 | Nasal Wash | Frozen | Negative RSV | Positive RSV | DSFA Positive for RSV |
| 4 | 60 | Nasal Wash | Frozen | Negative RSV | Positive RSV | DSFA Positive for RSV |
| 2 | 16 | Nasopharyngeal Swab | Fresh | Negative RSV | Positive RSV | PCR Positive for RSV |
| 3 | 207 | Nasal Swab | Frozen | Negative RSV | Positive RSV | |
| 3 | 226 | Nasal Swab | Frozen | Negative RSV | Positive RSV | |
| 3 | 2 | Nasopharyngeal Swab | Frozen | Negative RSV | Positive RSV | |
| 3 | 165 | Nasopharyngeal Swab | Frozen | Negative RSV | Positive RSV | |
| 3 | 173 | Nasopharyngeal Swab | Frozen | Negative RSV | Positive RSV | |
| 3 | 180 | Nasopharyngeal Swab | Frozen | Negative RSV | Positive RSV | |
| 3 | 181 | Nasopharyngeal Swab | Frozen | Negative RSV | Positive RSV | |
| 3 | 212 | Nasopharyngeal Swab | Frozen | Negative RSV | Positive RSV | |
| Site Number | Specimen # | Specimen Type | Fresh/Frozen | TRU RSV Result | Culture Result | Additional or repeat Testing and comments |
| 3 | 220 | Nasopharyngeal Swab | Frozen | Negative RSV | Positive RSV | |
| 3 | 224 | Nasopharyngeal Swab | Frozen | Negative RSV | Positive RSV | |
| 3 | 234 | Nasopharyngeal Swab | Frozen | Negative RSV | Positive RSV | |
| 3 | 238 | Nasopharyngeal Swab | Frozen | Negative RSV | Positive RSV | |
| 4 | 166 | Nasopharyngeal Swab | Frozen | Negative RSV | Positive RSV |
able 7. Analysis of samples producing discrepant results against tissue cultu
14
Table 7 Continued
.
15
Table 7 Continued
16
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incinnati, OH
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17
Meridian Bioscience, Inc.
Cincinnati, OH
Table 8. Results of reproducibility evaluation
| Sample ID | Qual.
Result | Site 1 | | | | | | Site 2 | | | | | | Site 3 | | | | | | | | | | | | | | | |
|---------------------------------------------------|-----------------|--------|-------|--|-------|-------|--|--------|-------|--|-------|-------|--|--------|-------|--|-------|-------|--|-------|-------|--|-------|-------|--|-------|-------|--|------------------------------|
| | | Day 1 | | | Day 2 | | | Day 3 | | | Day 1 | | | Day 2 | | | Day 3 | | | Day 1 | | | Day 2 | | | Day 3 | | | |
| | | Run 1 | Run 2 | | Run 1 | Run 2 | | Run 1 | Run 2 | | Run 1 | Run 2 | | Run 1 | Run 2 | | Run 1 | Run 2 | | Run 1 | Run 2 | | Run 1 | Run 2 | | Run 1 | Run 2 | | |
| 1 - HP | 5.5 | 4 | 4 | | 4 | 5 | | 4 | 5 | | 5 | 5 | | 5 | 5 | | 5 | 5 | | 5 | 5 | | 4 | 5 | | 5 | 5 | | |
| 2 - HP | 5.5 | 4 | 5 | | 5 | 5 | | 3 | 6 | | 4 | 5 | | 5 | 5 | | 4 | 2 | | 5 | 5 | | 5 | 5 | | 5 | 5 | | |
| 3 -- LP | 1.5 | 3 | 3 | | 2 | 3 | | 2 | 1 | | 2 | 2 | | 3 | 2 | | 2 | 2 | | 1 | 1 | | 1 | 2 | | 2 | 2 | | |
| 4-- LP | 1.5 | 2 | 2 | | 3 | 3 | | 2 | 2 | | 2 | 2 | | 2 | 3 | | 2 | 2 | | 1 | 1 | | 1 | 1 | | 1 | 2 | | |
| 5--LP | 1.5 | 2 | 2 | | 1 | 4 | | 1 | 1 | | 2 | 1 | | 2 | 2 | | 2 | 3 | | 1 | 2 | | 2 | 2 | | 2 | 2 | | |
| 6-HN | 0 | 0 | 0 | | 0 | 0 | | 0 | 0 | | 0 | 0 | | 0 | 0 | | NT | 0 | | 0 | 0 | | 0 | 0 | | 0 | 0 | | |
| 7 -- HN | 0 | 0 | 0 | | 0 | 0 | | 0 | 0 | | 0 | 0 | | 0 | 0 | | 0 | 0 | | 0 | 0 | | 0 | 0 | | 0 | 0 | | |
| 8 -- HN | 0 | 0 | 0 | | 0 | 0 | | 0 | 0 | | 0 | 0 | | 0 | 0 | | 0 | 0 | | 0 | 0 | | 0 | 0 | | 0 | 0 | | |
| 9-- LN | 0 | 0 | 0 | | 0 | 0 | | 0 | 0 | | 0 | 0 | | 0 | 0 | | 0 | 0 | | 0 | 0 | | 0 | 0 | | 0 | 0 | | |
| 10--LN | 0 | 0 | 0 | | 0 | 0 | | 0 | 0 | | 0 | 0 | | 0 | 0 | | 0 | 0 | | 0 | 0 | | 0 | 0 | | 0 | 0 | | |
| Ave high
neg value | | 0.0 | 0.0 | | 0.0 | 0.0 | | 0.0 | 0.0 | | 0.0 | 0.0 | | 0.0 | 0.0 | | 0.0 | 0.0 | | 0.0 | 0.0 | | 0.0 | 0.0 | | 0.0 | 0.0 | | |
| Ave low
pos value | | 2.3 | 2.3 | | 2.0 | 3.3 | | 1.7 | 1.3 | | 2.0 | 1.7 | | 2.3 | 2.3 | | 2.0 | 2.0 | | 1.3 | 1.3 | | 1.3 | 1.3 | | 1.7 | 2.0 | | |
| Percent
correlation
of cut off
specimens | 100% | | | | | | | | | | | | | | | | | | | | | | | | | | | | 100%
Over all Correlation |
= high positive; LP Legend: HP
18
Analytical sensitivity
The analytical sensitivity of this assay was established in tests with dilutions of 3 RSV A strains (VR-26, VR-1302, VR-1540) and 3 RSV B strains (VR-955, VR-1400, VR-1401). The lower limit of detection (see table below) is dependent on factors such as cell culture lines used, the number of passages performed and the effectiveness of the isolation methods. For these reasons, assay limit of detection levels may vary if other strains or samples are used.
| Strain ID | Strain Type | Limit of Detection (LoD)
TCID50/mL |
|-----------|-------------|---------------------------------------|
| VR-26 | A | $2.49 \times 10^2$ |
| VR-1302 | A | 4.47 |
| VR-1540 | A | $5.52 \times 10^1$ |
| VR-955 | B | 4.47 |
| VR-1400 | B | $1.10 \times 10^1$ |
| VR-1401 | B | 2.47 |
Assay specificity
The specificity of TRU RSV was tested utilizing the following bacterial, viral and yeast strains. RSV positive and negative respiratory specimens were spiked with ≥4 x 101/mL bacteria or yeast. Viruses were tested at levels ≥6.7 x 10 TCID30mL. None of the microorganisms tested yielded a positive result in the RSV-negative sample or interfered with detection of the RSV-positive sample. The RSV-negative respiratory sample was positive when spiked with RSV strain VR-26.
Adenovirus Types 1, 5 and 7A, Coxsackie Type A9, Human Coronavirus Types 229E and OC43, Cytomegalovirus, Influenza A (2 strains), Influenza B (1 strain), Human metapneumovirus, Measles, Parainfluenza Types 1, 2 and 3, Rhinovirus Type 39, Bacillus subtilis, Bordetella parapertussis, Bordetella pertussis, Branhamella catarrhalis, Candida albicans, Candida glabrata, Citrobacter freundii, Enterobacter cloacae, Escherichia coli, Haemophilus influenzae, Klebsiella oxytoca, Klebsiella pneumoniae, Listeria monocytogenes, Legionella pneumophila, Neisseria cinerea, Neisseria gonorrhoeae, Neisseria meningitidis, Nocardia asteroides, Proteus vulgaris, Pseudomonas aeruginosa, Pseudomonas fluorescens, Serratia liquifaciens, Staphvlococcus aureus. Staphylococcus aureus (Cowan I), Staphylococcus epidermidis, Streptococcus (not typed), Streptococcus Groups A, B, D, F, and G, Streptococcus pneumoniae.
A clinical sample containing Epstein Barr virus at 2.32 x 10° genome equivalents/mL was nonreactive with TRU RSV.
Tests for interfering substances
The following substances, when introduced directly into nasal samples, do not interfere with testing at the concentrations identified: Acetaminophen (10 mg/mL), Acetylsalicylic acid (20 mg/mL), Albuterol (9.1% v/v), Halls® Throat Drops (20 mg/mL), Ludens® Throat Drops (20 mg/mL), Chlorpheniramine maleate (1.7 mg/mL), Clemastine fumarate (5mg/mL), Diphenhydramine HCl (5 mg/mL), Dextromethorphan (9.1% v/v), Naproxen sodium (10 mg/mL), Phenylephrine hydrochloride (9.1% v/v), Oxymetazoline (9.1% v/v), Guaifenesin (9.1% v/v), Pseudoephedrine HCI (20 mg/mL), Listerine® Mouthwash (9.1% v/v).
Whole blood at concentrations greater than 2.9% interpretation. Chlorpheniramine maleate at concentrations greater than 1.7 mg/mL may cause false-positive test results.
19
CONCLUSIONS
TRU RSV:
-
- Can be used reliably in the clinical laboratory for the rapid detection of RSV antigens in the sample types defined in product labeling, and
- Performs similarly to its predicate ImmunoCard STAT! RSV. 2.
BIBLIOGRAPHY
-
- Cote PJ, Fernie BF, Ford EC et al. Monoclonal antibodies to respiratory syncytial virus: determination of virus neutralization and other antibody systems using infected human and murine cells. J Virol Meth 1981;3:137-47.
-
- Swenson PD, Kaplan MH. Rapid detection of respiratory syncytial virus in nasopharyngeal aspirates by a commercial enzyme immunoassay. J Clin Microbiol 1986;23:485-8.
20
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/20/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or a bird in flight. The symbol is made up of three curved lines that converge at the bottom.
OCT 1 8 2007
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Susan Rolih Official Correspondent Meridian BioScience, Inc. 3471 River Hills Drive Cincinnati, OH 45244
Re: K071101
Trade/Device Name: TRU RSV Regulation Number: 21 CFR 866.3480 Regulation Name: Respiratory syncytial virus serological reagents Regulatory Class: Class I Product Code: GOG Dated: October 5, 2007 Received: October 10, 2007
Dear Ms. Rolih:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug. and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration. Iisting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).
21
Page 2 -
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at 240-276-0450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Sally attaym
Sally A. Hojvat, M.Sc., Ph.D. Director Division of Microbiology Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
22
Meridian Bioscience, Inc. Cincinnati, OH
510(k) Premarket Notification TRU RSV
INDICATIONS FOR USE STATEMENT TRU RSV
510(K) Number: K021101
TRU RSV is a rapid, qualitative, lateral-flow immunoassay for the detection of Respiratory Syncytial Virus (RSV) antigens (fusion protein or nucleoprotein) in human nasal wash, nasopharyngeal aspirate and nasal and nasopharyngeal swab samples. It is designed to test specimens from symptomatic patients aged 5 years or less. A negative result does not preclude RSV infection. It is recommended that all negative test results be confirmed by cell culture.
Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) k 071101
Section 4, Page 1 of 1: Rev 10/05/07