scholarly journals RLEP LAMP for the laboratory confirmation of leprosy: towards a point-of-care test

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Malkin Saar ◽  
Marcus Beissner ◽  
Fatih Gültekin ◽  
Issaka Maman ◽  
Karl-Heinz Herbinger ◽  
...  
Keyword(s):  
Health Care ◽  
Primary Health Care ◽  
Limit Of Detection ◽  
Point Of Care ◽  
Clinical Validation ◽  
Care Level ◽  
Primary Health ◽  
Primary Health Care Level ◽  
Leprosy Patients ◽  
Technical Validation

Abstract Background Nucleic acid-based amplification tests (NAAT), above all (q)PCR, have been applied for the detection of Mycobacterium leprae in leprosy cases and household contacts with subclinical infection. However, their application in the field poses a range of technical challenges. Loop-mediated isothermal amplification (LAMP), as a promising point-of-care NAAT does not require sophisticated laboratory equipment, is easy to perform, and is applicable for decentralized diagnosis at the primary health care level. Among a range of gene targets, the M. leprae specific repetitive element RLEP is regarded as highly sensitive and specific for diagnostic applications.  Methods Our group developed and validated a dry-reagent-based (DRB) RLEP LAMP, provided product specifications for customization of a ready-to-use kit (intended for commercial production) and compared it against the in-house prototype. The assays were optimized for application on a Genie® III portable fluorometer. For technical validation, 40 “must not detect RLEP” samples derived from RLEP qPCR negative exposed and non-exposed individuals, as well as from patients with other conditions and a set of closely related mycobacterial cultures, were tested together with 25 “must detect RLEP” samples derived from qPCR confirmed leprosy patients. For clinical validation, 150 RLEP qPCR tested samples were analyzed, consisting of the following categories: high-positive samples of multibacillary (MB) leprosy patients (> 10.000 bacilli/extract), medium-positive samples of MB leprosy patients (1.001–10.000 bacilli/extract), low-positive samples of MB leprosy patients (1–1.000 bacilli/extract), endemic controls and healthy non-exposed controls; each n = 30.  Results Technical validation: both LAMP formats had a limit of detection of 1.000 RLEP copies, i.e. 43–27 bacilli, a sensitivity of 92% (in-house protocol)/100% (ready-to-use protocol) and a specificity of 100%. Reagents were stable for at least 1 year at 22 °C. Clinical validation: Both formats showed a negativity rate of 100% and a positivity rate of 100% for high-positive samples and 93–100% for medium positive samples, together with a positive predictive value of 100% and semi-quantitative results. The positivity rate for low-positive samples was 77% (in-house protocol)/43% (ready-to-use protocol) and differed significantly between both formats.  Conclusions The ready-to-use RLEP DRB LAMP assay constitutes an ASSURED test ready for field-based evaluation trials aiming for routine diagnosis of leprosy at the primary health care level.

scholarly journals Video-otoscopy recordings for diagnosis of childhood ear disease using telehealth at primary health care level

2014 ◽  
Vol 20 (6) ◽  
pp. 300-306 ◽  
Author(s):  
Leigh Biagio ◽  
De Wet Swanepoel ◽  
Claude Laurent ◽  
Thorbjörn Lundberg
Keyword(s):  
Health Care ◽  
Primary Health Care ◽  
Care Level ◽  
Primary Health ◽  
Primary Health Care Level

scholarly journals Injection safety at primary health care level in south-western Saudi Arabia

2009 ◽  
Vol 15 (2) ◽  
pp. 443-450 ◽  
Author(s):  
A.A. Mahfouz ◽  
I. Abdel Moneim ◽  
M.Y. Khan ◽  
A.A. Daffalla ◽  
M.M. Diab ◽  
...  
Keyword(s):  
Health Care ◽  
Saudi Arabia ◽  
Primary Health Care ◽  
Care Level ◽  
Primary Health ◽  
Primary Health Care Level ◽  
Injection Safety

scholarly journals Minimizing Delays in the Breast Cancer Pathway by Integrating Breast Specialty Care Services at the Primary Health Care Level in Zambia

2020 ◽  
pp. 859-865 ◽  
Author(s):  
Mutumba Songiso ◽  
Leeya F. Pinder ◽  
Jabulani Munalula ◽  
Anna Cabanes ◽  
Sarah Rayne ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Health Care ◽  
Primary Health Care ◽  
Early Stage ◽  
Ultrasound Guided ◽  
Care Level ◽  
Pathologic Diagnosis ◽  
Primary Health ◽  
Primary Health Care Level ◽  
Breast Care

PURPOSE In Zambia, more than two-thirds of female patients with breast cancer present with late-stage disease, leading to high mortality rates. Most of the underlying causes are associated with delays in symptom recognition and diagnosis. By implementing breast care specialty services at the primary health care level, we hypothesized that some of the delays could be minimized. METHODS In March 2018, we established a breast care specialty clinic for women with symptomatic disease within 1 of the 5 district hospitals in Lusaka. The clinic offers breast self-awareness education, clinical breast examination, breast ultrasound, ultrasound-guided breast biopsy, surgery, referral for chemoradiation, follow-up care, and electronic medical records. RESULTS Between March 2018 and April 2019, of 1,790 symptomatic women who presented to the clinic, 176 (10%) had clinical and/or ultrasound indications for histologic evaluation. Biopsy specimens were obtained using ultrasound-guided core-needle procedures, all of which were performed on the same day as the initial visit. Of the 176 women who underwent biopsy, 112 (64%) had pathologic findings compatible with a primary breast cancer, and of these, 42 (37%) were early-stage (stage I/II) disease. Surgery for early-stage cancers was performed at the district hospital within 2 weeks of the time of definitive pathologic diagnosis. Patients with advanced disease were referred to the national cancer center for multimodality therapy, within a similar time frame. CONCLUSION Breast care specialty services for symptomatic women were established in a district-level hospital in a resource-constrained setting in Africa. As a result, the following time intervals were minimized: initial presentation and performance of clinical diagnostics; receipt of a definitive pathologic diagnosis and initiation of surgery; receipt of a definitive pathologic diagnosis and referral.

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