Corneal Ulcer, Endophthalmitis, Eye Infections, Keratitis
Conditions
Keywords
Multiplex solid-phase strip PCR, Eye Infections, Endophthalmitis, Corneal Ulcer, Keratitis, Corneal Scraping Samples
Brief summary
The aim of this study is to see if multiplex strip PCR will detect the pathogen that causing eye infection from the corneal scraping samples with higher sensitivity and specificity than the current gold standard.
Interventions
DIAGNOSTIC_TESTMultiplex Strip PCR
Corneal scraping from patients will have its DNA extracted and eluted in the buffer. The DNA than mixed with the primer strips tube and be analyzed in Real-Time PCR machine. According to the record information from the hospital, the pathogen that usually found from endophthalmitis, keratitis, corneal ulcer diseases in our hospital is Pseudomonas sp., Staphylococcus aureus, Staphylococcus epidermidis, Acinetobacter sp., Pseudomonas aeruginosa, Acanthamoeba sp., Aspergillus fumigatus, Aspergillus flavus, Fusarium sp., and Candida albicans. And based on the report from Zhao et al (2014) Herpes Simplex Virus may be detected from patients with keratitis. Therefore in this study, we are trying to detect all of the pathogens simultaneously using the real-time PCR assay from patients corneal scraping who experience eye infections as mention above.
Sponsors
Fakultas Kedokteran Universitas Indonesia
Study design
Observational model
CASE_CROSSOVER
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Registered as new patients since July 2019 in RSCM Kirana * Age more than 18 years * Have an eye infection (keratitis, endophthalmitis and corneal ulcer) which required corneal scrapping sampling for further diagnosis
Exclusion criteria
\- Not willing to become the participants by not filling the informed consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Higher sensitivity and specificity by multiplex strip PCR than current gold standard | 4 months | Ferrer and Alio (2011) report from 10 years of study shown that culture test as current gold standard will provide positive value by 59.3% for detecting keratitis pathogen. Based on this report, we see the potential increase of positive value by using multiplex PCR around 20 points (70%). Sensitivity will be calculated by true positive divided by all positive patients and specificity will be calculated by true negative divided by all negative patients. The results will be compared with the current gold standard with target increase 20 points or 70%. |
Countries
Indonesia
Contacts
Primary ContactDr. dr. Made Susiyanti, Sp.M(K)
Outcome results
None listed