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510(k) Data Aggregation
(123 days)
The Alethia CMV Assay Test System includes separately provided test kits for the Alethia CMV DNA Amplification Assay and the Alethia CMV External Control Reagents.
The Alethia CMV DNA Amplification Assay, performed on the Alethia instrument, is a qualitative, in vitro diagnostic test system for the direct detection of Cytomegalovirus (CMV) DNA in saliva samples from neonates younger than 21 days of age. The test is used as an aid in the diagnosis of congenital CMV infection. The results of this test should be used in conjunction with the results of other clinical findings.
Flocked swabs should be used to collect saliva from neonates. The swab can be collected dry, without viral transport media (VTM), or placed in no more than 1 mL VTM.
The Alethia CMV External Control Reagents are used as part of a routine quality control program to aid the user in detection of unexpected conditions that may lead to test errors. The external controls are intended for use with the Alethia CMV DNA Amplification Assay; the controls are not intended for use with other assays or systems.
The Alethia CMV Assay Test System, including the Alethia CMV DNA Amplification Assay and the Alethia CMV External Controls, is based on loopmediated amplification (LAMP) technology. The assay targets a region of the Cytomegalovirus genome that is conserved across multiple CMV strains. The Alethia CMV target is a 194 base pair (bp) sequence of the Human herpesvirus 5 genome.
LAMP uses specially designed primers to provide for specific and continuous isothermal DNA amplification. A bv-product of amplification is magnesium pyrophosphate, which forms a white precipitate leading to a turbid solution. Reaction solution absorbance characteristics are monitored by the Alethia™ instrument.
Changes in reaction solution turbidity created by precipitation of magnesium pyrophosphate indicate the presence of target DNA. The absence of target DNA results in no significant change in sample absorbance.
The Alethia CMV DNA Amplification Assay is a qualitative in vitro diagnostic test for the direct detection of Cytomegalovirus (CMV) DNA in saliva samples from neonates younger than 21 days of age. It aids in the diagnosis of congenital CMV infection.
Here's an analysis of the acceptance criteria and the study that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (Implicit from study results and regulatory requirements) | Reported Device Performance (from "Clinical studies" section) |
|---|---|
| Clinical Performance: | |
| Positive Percent Agreement (PPA) with Composite Reference Method | 100% (39/39) [95% CI: 91.0%; 100%] |
| Negative Percent Agreement (NPA) with Composite Reference Method | 99.8% (1,472/1,475) [95% CI: 99.4%; 99.9%] |
| Invalid Rate (Initial) | 1.7% (27/1,548) |
| Invalid Rate (Final, after re-testing) | 0.06% (1/1,548) [95% CI: 0.01%; 0.37%] |
| Analytical Performance: | |
| Limit of Detection (LoD) - Dry Swab | 1,025 copies/mL |
| Limit of Detection (LoD) - Swab in VTM | 15,686 copies/mL |
| Inclusivity (tested for 3 additional CMV strains) | 100% positive for AD-169, Toledo, and Towne strains at 2-3X LoD. |
| Cross-Reactivity (panel of 40 microorganisms and human genomic DNA) | No cross-reactivity observed. |
| Microbial Interference (panel of 40 microorganisms and human genomic DNA) | No microbial interference observed (all CMV positive samples remained positive). |
| Chemical/Biological Interfering Substances | No interference observed with specified substances at tested concentrations (except for mucin at 50 mg/mL, mitigated by labeling). |
| Sample Stability (room temp, refrigerated, frozen, freeze-thaw) | Supports storage for up to 48 hours at 19-30°C, 7 days at 2-8°C, or **frozen at |
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