(417 days)
ID-FISH Plasmodium Genus Test Kit (PlasG) and ID-FISH Plasmodium falciparum and P. vivax Combo Test Kit (PlasFV) are intended for in vitro diagnostic use in the clinical laboratory for detection of Plasmodium species in human venous whole blood (EDTA) samples from patients suspected of Plasmodium infection. The test kits are intended to aid in the diagnosis of malaria and to aid in the differential diagnosis of P. falciparum and P. vivax infection. The test kits should be used only on samples from patients with a clinical history, signs and symptoms consistent with malaria, and are not intended as a screen for asymptomatic patients.
The ID-FISH Plasmodium Genus Test Kit is a qualitative test for detection of malaria parasites in blood smears. Positive results should be supplemented with the Plasmodium species specific test kit, ID-FISH Plasmodium falciparum and P. vivax Combo Test Kit for identification and differentiation of Plasmodium falciparum and Plasmodium vivax. The results of these test kits should be used in conjunction with other diagnostic test results. Clinical performance has not been established for P. ovale, P. malariae, or P. knowlesi.
The ID-FISH Plasmodium Genus Test Kit (PlasG) and ID-FISH Plasmodium falciparum and P. vivax Combo Test Kit (PlasFV) are fluorescence in situ hybridization (FISH) assays to detect Plasmodium spp. or P. falciparum or P. vivax parasites in thin film blood smears prepared from EDTA venous whole blood samples.
Here's a breakdown of the acceptance criteria and the study proving the device meets them, based on the provided text:
Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria/Metric | Target Performance (Implicit from study results) | Reported Device Performance (PlasG) | Reported Device Performance (PlasFV - P. falciparum) | Reported Device Performance (PlasFV - P. vivax) |
|---|---|---|---|---|---|
| Reproducibility | Negative Agreement | High agreement (e.g., >95%) | 99.4% (178/179) | 99.4% (178/179) | N/A (Kit differentiates species) |
| Positive Agreement (Low P.f.) | 100% | 100% (178/178) | 99.4% (177/178) | N/A | |
| Positive Agreement (Mod P.f.) | 100% | 100% (180/180) | 100% (180/180) | N/A | |
| Positive Agreement (Low P.v.) | 100% | 100% (180/180) | N/A | 100% (180/180) | |
| Positive Agreement (Mod P.v.) | 100% | 100% (180/180) | N/A | 100% (180/180) | |
| Limit of Detection (LoD) | Detection Rate | >= 95% at specified concentration | 143 parasites/uL (P.f.), 126 parasites/uL (P.v.) | 143 parasites/uL (P.f.), 126 parasites/uL (P.v.) | 143 parasites/uL (P.f.), 126 parasites/uL (P.v.) |
| Analytical Reactivity (Inclusivity) | Detection of Plasmodium species | All Plasmodium positive samples detected | All 11 Plasmodium positive samples detected | P. falciparum and P. vivax positive samples correctly identified | P. falciparum and P. vivax positive samples correctly identified |
| Analytical Specificity (Cross-Reactivity) | No false positive results | 0 false positives | No false positives with 29 pathogens/76 non-malarial blood samples | No false positives with 29 pathogens/76 non-malarial blood samples (for respective probes) | No false positives with 29 pathogens/76 non-malarial blood samples (for respective probes) |
| Interfering Substances | No false positives/negatives | No impact on results | No false positives, expected results for positive samples | No false positives, expected results for positive samples | No false positives, expected results for positive samples |
| Specimen Stability | Stable for 5 years (fixed slides storage) | No noticeable reduction in staining intensity, expected result | All samples produced expected results | All samples produced expected results | All samples produced expected results |
| Clinical Performance (Endemic Regions - All Comers) | Sensitivity (Plasmodium spp.) | >95% (lower bound 95% CI >90%) | 95.7% (95% CI 93.0% - 97.4%) | N/A | N/A |
| Specificity (Plasmodium spp.) | High specificity, PCR confirmation for "false positives" | 92.6% (95% CI 89.5% - 94.9%) - improved by PCR | N/A | N/A | |
| Sensitivity (P. falciparum) | High sensitivity | N/A | 97.4% (95% CI 93.6% - 99.0%) | N/A | |
| Specificity (P. falciparum) | High specificity, PCR confirmation for "false positives" | N/A | 96.1% (95% CI 94.1% - 97.4%) - improved by PCR | N/A | |
| Sensitivity (P. vivax) | High sensitivity | N/A | N/A | 91.2% (95% CI 86.0% - 94.6%) | |
| Specificity (P. vivax) | High specificity, PCR confirmation for "false positives" | N/A | N/A | 98.3% (95% CI 96.8% - 99.1%) - improved by PCR | |
| Clinical Performance (Non-Endemic Regions) | Specificity (Plasmodium spp.) | High specificity | 100% (150/150) | 100% (150/150) | 100% (150/150) |
| Clinical Performance (Low Parasitemia) | Sensitivity (Plasmodium spp. |
§ 866.3367 Device to detect and identify microbial nucleic acids by FISH in clinical specimens.
(a)
Identification. A device to detect and identify microbial nucleic acids by fluorescence in situ hybridization (FISH) in clinical specimens is an in vitro diagnostic device intended for the detection and identification of microbial pathogens in specimens collected from patients with signs and symptoms of infection. The device is intended to aid in the diagnosis of human disease in conjunction with clinical signs and symptoms and other laboratory findings.(b)
Classification. Class II (special controls). The special controls for this device are:(1) Design verification and validation must include the following:
(i) Detailed device description documentation, including the device components, instrument requirements, ancillary reagents required but not provided, and a detailed explanation of the methodology, including all pre-analytical methods for processing of specimens, probe sequences, and rationale for probe sequence selection;
(ii) Detailed description of the fluorophores, signal source, detection mechanism, and method of result interpretation;
(iii) Detailed documentation from the following analytical studies: analytical sensitivity (Limit of Detection), inclusivity, reproducibility, interference, cross reactivity, and specimen stability; and
(iv) Detailed documentation from a clinical study that includes prospective (sequential) samples. The study, performed on a study population consistent with the intended use population, must compare the device performance to results obtained from appropriate and well-accepted comparator methods.
(2) The labeling required under § 809.10(b) of this chapter must include:
(i) A statement that the device is intended to be used in conjunction with clinical history, signs, symptoms, and the results of other diagnostic testing;
(ii) A detailed explanation of the interpretation of results and acceptance criteria for any quality control testing; and
(iii) A limitation that negative results do not preclude the possibility of infection.