scholarly journals ANALISIS TINDAK PIDANA PENGGUNAAN ALAT RAPID TEST ANTIGEN BEKAS OLEH OKNUM PETUGAS MEDIS KIMIA FARMA

Yurispruden ◽  
2021 ◽  
Vol 4 (2) ◽  
pp. 223
Author(s):  
Indah Wahyuni Dian Ratnasari
Keyword(s):  
Rapid Test ◽  
Rt Pcr ◽  
Test Antigen

Biaya tes RT-PCR atau rapid test antigen yang cukup mahal menjadikan tes RT-PCR atau rapid test antigen menjadi bisnis yang sangat menguntungkan bagi penyedia jasa pelayanan kesehatan. Hal tersebut terlihat dari banyaknya penyedia jasa yang menyediakan jasa tes RT-PCR atau rapid test antigen. Peluang tersebut membuat oknum petugas medis Kimia Farma di Bandara Internasional Kualanamu Kota Medan Sumatera Utara memanfaatkan keadaan tersebut dengan cara melakukan daur ulang alat rapid test antigen, kemudian menggunakan alat rapid test antigen bekas kepada masyarakat yang melakukan tes. Berdasarkan hal tersebut dipandang perlu untuk mengkaji terkait pengaturan hukum yang dilanggar dalam penggunaan alat rapid test antigen bekas oleh oknum petugas medis kimia farma, serta ancaman pidana yang dapat diterapkan atas penggunaan alat rapid test antigen bekas oleh oknum petugas medis kimia farma.

scholarly journals Perbedaan uji diagnostik antigen, antibodi, RT-PCR dan tes cepat molekuler pada Coronavirus Disease 2019

2020 ◽  
Vol 20 (3) ◽  
Author(s):  
Budi Yanti ◽  
Fitri Dewi Ismida ◽  
Klarina Elsa Siti Sarah
Keyword(s):  
Acute Respiratory Distress Syndrome ◽  
Respiratory Distress Syndrome ◽  
Respiratory Distress ◽  
Distress Syndrome ◽  
Rapid Test ◽  
Rt Pcr ◽  
Test Antigen

Coronavirus Disease 2019 (COVID-19) merupakan jenis penyakit baru yang teridentifikasi pada manusia. Virus penyebab COVID-19 ini dinamakan SARS-CoV-2. Angka mortalitas yang disebabkan oleh SARS-COV-2 (3,8%), hal ini lebih rendah dari angka mortalitas yang disebabkan oleh infeksi coronavirus sebelumnya, yaitu SARS-COV (10%) dan MERS-COV (37,1%). Namun, angka penularan dari SARS-COV-2 jauh lebih tinggi, yaitu 10 kali lipat bersifat lebih infeksius. Hal ini dapat dijadikan sebagai penjelasan penyebab dari mewabahnya virus yang terjadi secara mendadak. Infeksi SARS-COV-2 terjadi melalui droplets, kontak dengan cairan tubuh pasien yang terinfeksi, benda-benda yang terkontaminasi. COVID-19 dapat menimbulkan tanda dan gejala yang bervariasi. (WHO-2019-nCOV) Infeksi ini dapat menyebabkan gejala ISPA ringan hingga berat bahkan sampai terjadi Acute Respiratory Distress Syndrome (ARDS), sepsis dan syok septik. Dalam melakukan diagnosis diperlukannya pemeriksaan yang memiliki tingkat sensitifitas dan spesifisitas yang tinggi. Pemeriksaan penunjang yang dilakukan mencakup pemeriksaan radiologis, dan pemeriksaan laboratorium (uji antigen, antobodi, serologi dan molekuler). Dalam referat ini akan dibahas mengenai beberapa pemeriksaan diagnostik yang umum dilakukan saat ini, yaitu rapid test antigen, rapid test antibodi, ELISA, RT-PCR dan Tes Cepat Molekuler. Setiap pemeriksaan memiliki kelebihan dan kekurangannya masing-masing. Namun pemeriksaan baku emas dalam mendiagnosis COVID-19 tetap menggunakan RT-PCR.

scholarly journals SARS-CoV-2 in peritoneal swabs from asymptomatic patients undergoing emergency abdominal surgery

2021 ◽  
Vol 2021 (4) ◽  
Author(s):  
Jasim AlAradi ◽  
Rawan A Rahman AlHarmi ◽  
Mariam AlKooheji ◽  
Sayed Ali Almahari ◽  
Mohamed Abdulla Isa ◽  
...  
Keyword(s):  
Peritoneal Fluid ◽  
Case Series ◽  
Rapid Test ◽  
Nasopharyngeal Swab ◽  
Rt Pcr ◽  
Protective Measures ◽  
The Public ◽  
Asymptomatic Patients ◽  
Number Of Patients ◽  
Viral Transfer

Abstract This is a case series of five patients with acute abdomen requiring surgery who tested positive for coronavirus disease 2019 (COVID-19) and were asymptomatic, with the purpose of detection of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in peritoneal fluid. Nasopharyngeal swab was done as a prerequisite for admission or prior to admission as part of random testing. Two methods of viral testing were employed: Xpert® Xpress SARS-CoV-2 (rapid test) and real-time reverse transcription polymerase chain reaction (RT-PCR). Either or both tests were done, with the former performed for patients requiring surgery immediately. Surgery was performed within 24–36 h from admission. Peritoneal fluid swabs were obtained for the detection of SARS-CoV-2 using RT-PCR test. Swabs were immediately placed in viral transfer media and delivered to the public health laboratory in an ice bag. SARS-CoV-2 was not detected in peritoneal swabs. Due to the limited number of patients, further studies are required; yet, protective measures should still be taken by surgeons when dealing with COVID-19 cases.

scholarly journals Avian influenza and Newcastle disease virusindead chickens in markets in Dhaka, Bangladesh in 2011-2012

2017 ◽  
Vol 33 (1) ◽  
pp. 8-15
Author(s):  
LR Barman ◽  
RD Sarker ◽  
BC Das ◽  
EH Chowdhury ◽  
PM Das ◽  
...  
Keyword(s):  
Influenza Virus ◽  
Avian Influenza ◽  
Newcastle Disease ◽  
Rapid Test ◽  
Type A ◽  
Antigen Test ◽  
Rt Pcr ◽  
Test Kit ◽  
Live Bird

A virological survey for avian influenza (AI) and Newcastle disease (ND) was conducted in two selected live bird markets (LBMs), namely Kaptan Bazar and Karwan Bazar in Dhaka city, Bangladesh from August 2011 to July 2012. A total of 513 dead chickens were collected. An immune-chromatographic rapid antigen test for Type A influenza virus and both conventional and real time RT-PCR were used for the detection and characterization of AI and ND viruses. All carcasses were first screened by the rapid antigen test kit and 93 were positive for Type A influenza virus. RT-PCR on a representative number of rapid antigen test positive samples (n = 24) confirmed the presence of Type A influenza virus and mostly H5 influenza virus (22 out of 24 tested samples). Influenza rapid test negative samples (n = 420) were subjected to routine necropsy. Heat stress, suffocation and physical injury were the most common cause of mortality (163 cases), followed by ND, suspected to be the cause of 85 deaths. On molecular investigation of these 85 samples, the presence of ND virus was confirmed in 59 and AI virus in 6; 15 were negative for both ND and AI viruses and 5 were unsuitable for investigation. Among the 59 ND confirmed cases 18 also contained AI virus. In summary, out of 513 carcasses 117 (22.81%) contained AI virus and 59 (11.50%) contained ND virus. Eighteen (3.51%) carcasses contained both AI and ND viruses. The findings suggest that both AI and ND should be considered as major threats to the poultry industry.Bangl. vet. 2016. Vol. 33, No. 1, 8-15

scholarly journals High-throughput immunoassays for SARS-CoV-2, considerable differences in performance when comparing three methods

2020 ◽  
Author(s):  
Oskar Ekelund ◽  
Kim Ekblom ◽  
Sofia Somajo ◽  
Johanna Pattison-Granberg ◽  
Karl Olsson ◽  
...  
Keyword(s):  
High Throughput ◽  
Rapid Test ◽  
Performance Criteria ◽  
Clinical Use ◽  
Rt Pcr ◽  
Regulatory Authorities ◽  
Flow Test ◽  
Lateral Flow Test ◽  
High Level ◽  
Positive Results

Background: The recently launched high-throughput assays for the detection of antibodies against SARS-CoV-2 may change the managing strategies for the COVID-19 pandemic. This study aimed at investigating the performance of three high-throughput assays and one rapid lateral flow test relative to the recommended criteria defined by regulatory authorities. Methods: A total of 133 samples, including 100 pre-pandemic samples, 20 samples from SARS-CoV-2 RT-PCR positive individuals, and 13 potentially cross-reactive samples were analysed with SARS-CoV-2 IgG (Abbott), Elecsys Anti-SARS-CoV-2 (Roche), LIAISON SARS-CoV-2 S1/S2 IgG (DiaSorin) and 2019-nCOV IgG/IgM Rapid Test (Dynamiker Biotechnology Co). Results: All assays performed with a high level of specificity; however, only Abbott reached 100% (95% CI 96.3-100). The pre-pandemic samples analysed with Roche, DiaSorin and Dynamiker Biotechnology resulted in two to three false-positive results per method (specificity 96.9-98.0%). Sensitivity differed more between the assays, Roche exhibiting the highest sensitivity (100%, CI 83.9-100). The corresponding figures for Abbott, DiaSorin and Dynamiker Biotechnology were 85.0%, 77.8% and 75.0%, respectively. Conclusions: The results of the evaluated SARS-CoV-2 assays vary considerably as well as their ability to fulfil the performance criteria proposed by regulatory authorities. Introduction into clinical use in low-prevalent settings, should therefore, be made with caution.

scholarly journals Field evaluation of a rapid antigen test (Panbio™ COVID-19 Ag Rapid Test Device) for the diagnosis of COVID-19 in primary healthcare centers

2020 ◽  
Author(s):  
Eliseo Albert ◽  
Ignacio Torres ◽  
Felipe Bueno ◽  
Dixie Huntley ◽  
Estefanía Molla ◽  
...  
Keyword(s):  
Primary Healthcare ◽  
Rapid Test ◽  
Field Evaluation ◽  
Antigen Test ◽  
Rt Pcr ◽  
Test Device ◽  
Specificity And Sensitivity ◽  
Primary Healthcare Centers

AbstractWe evaluated the Panbio™ COVID-19 AG Rapid Test Device (RAD) for the diagnosis of COVID-19 in symptomatic patients attended in primary healthcare centers (n=412). Overall specificity and sensitivity of RAD was 100% and 79.6%, respectively, taking RT-PCR as the reference. SARS-CoV-2 could not be cultured from specimens yielding RT-PCR+/RAD- results.

Point-Of-Care Clinical Evaluation of the Clungene® SARS-CoV-2 Virus IgG/IgM 15-minute rapid test cassette with the Cobas® Roche RT-PCR platform in patients with or without Covid-19

2021 ◽  
Author(s):  
Fadi Haddad ◽  
Christopher C Lamb ◽  
Ravina Kullar ◽  
George Sakoulas
Keyword(s):  
Symptom Onset ◽  
Serological Test ◽  
Point Of Care ◽  
Diagnostic Testing ◽  
Rapid Test ◽  
Lateral Flow ◽  
Added Value ◽  
Lateral Flow Immunoassay ◽  
Rt Pcr ◽  
Past Infection

Background: Covid-19 remains a pandemic with multiple challenges to confirm patient infectivity: lack of sufficient tests, accurate results, validated quality, and timeliness of results. We hypothesize that a rapid 15-minute Point-Of-Care serological test to evaluate past infection complements diagnostic testing for Covid-19 and significantly enhances testing availability. Method: A three arm observational study at Sharp Healthcare, San Diego, California was conducted using the Clungene® lateral flow immunoassay (LFI) and compared with the Cobas® Roche RT PCR results. Arm 1: Thirty-five (35) subjects with confirmed Covid-19 using RT-PCR were tested twice: prior to 14 days following symptom onset and once between 12 and 70 days. Arm 2: Thirty (30) subjects with confirmed Covid-19 using RT-PCR were tested 12-70 days post symptom onset. Arm 3: Thirty (30) subjects with a negative RT-PCR for Covid-19 were tested 1-10 days following the RT-PCR test date. Results: Specificity of confirmed negative Covid-19 by RT-PCR was 100% (95% CI, 88.4%-100.0%); meaning there was 100% negative positive agreement between the RT-PCR and the Clungene® serological test results. Covid-19 subjects tested prior to day 7 symptom onset were antibody negative. In subjects 7-12 days following symptom onset with a confirmed positive Covid-19 by RT-PCR, the combined sensitivity of IgM and IgG was 58.6% (95% CI, 38.9%-76.5%). In subjects 13-70 days following symptom onset with a confirmed positive Covid-19 by RT-PCR the combined sensitivity of IgM and IgG was 90.5% (95% CI, 80.4%-96.4%). Conclusion: The Clungene® lateral flow immunoassay (LFI) is a useful tool to confirm individuals with an adaptive immune response to SARS-CoV-2 indicating past infection. Providing Point-Of-Care results within 15 minutes without any laboratory instrumentation or specialized software has an added value of increasing test availability to patients who have been symptomatic for more than one week to confirm past infection. Performance characteristics are optimal after 13 days with a sensitivity and specificity of 90% and 100%, respectively.

scholarly journals Reference Human Rotavirus A Genome Sequence from a Previously Vaccinated Child with Diarrhea in Nigeria

2020 ◽  
Vol 9 (5) ◽  
Author(s):  
T. O. C. Faleye ◽  
U. E. George ◽  
C. Simsek ◽  
O. A. Arowolo ◽  
O. M. Adewumi ◽  
...  
Keyword(s):  
Genome Sequence ◽  
Reverse Transcription ◽  
Rapid Test ◽  
Etiologic Agent ◽  
Rt Pcr ◽  
Rotavirus A ◽  
Reverse Transcription Pcr ◽  
Human Rotavirus ◽  
A Genome ◽  
Genotype Constellation

In 2018, a 26-month-old girl, fully vaccinated with Rotarix in 2016, presented with fever, diarrhea, and vomiting. A rapid test showed that her feces contained rotavirus A (RVA). VP7 reverse transcription-PCR (RT-PCR) and Illumina sequencing showed that a G1P[8] strain with a Wa-like genotype constellation was the etiologic agent. This is the first near-complete RVA genome sequence from Nigeria.

scholarly journals Diagnostic Properties of Three SARS-CoV-2 Antibody Tests

Diagnostics ◽  
2021 ◽  
Vol 11 (8) ◽  
pp. 1441
Author(s):  
Suelen Basgalupp ◽  
Giovana dos Santos ◽  
Marina Bessel ◽  
Lara Garcia ◽  
Ana Carolina de Moura ◽  
...  
Keyword(s):  
Rapid Test ◽  
Epidemiological Studies ◽  
Antibody Detection ◽  
Sample Collection ◽  
Rt Pcr ◽  
Igg Antibody ◽  
Serological Tests ◽  
High Agreement ◽  
High Level ◽  
Antibody Tests

Serological assays emerged as complementary tools to RT-PCR in the diagnosis of SARS-CoV-2 as well as being needed for epidemiological studies. This study aimed to assess the performance of a rapid test (RT) compared to that of serological tests using finger prick blood samples. A total of 183 samples were evaluated, 88 of which were collected from individuals with negative RT-PCR and 95 from positive RT-PCR individuals. The diagnostic performance of RT (WONDFO®) and LUMIT (PROMEGA®) were compared to that of ELISA (EUROIMMUN®) for detecting antibodies against SARS-CoV-2 according to time from symptoms onset. The IgG antibody tests were detected in 77.4% (LUMIT), 77.9% (RT), and 80.0% (ELISA) of individuals. The detection of antibodies against SARS-CoV-2 increases in accordance with increasing time from symptoms onset. Considering only time from symptoms onset >21 days, the positivity rate ranged from 81.8 to 97.0% between the three tests. The RT and LUMIT showed high agreement with ELISA (agreement = 91.5%, k = 0.83, and agreement = 96.3%, k = 0.9, respectively) in individuals who had symptoms 15 to 21 days before sample collection. Compared to that of the ELISA assay, our results show sensitivity ranged from 95% to 100% for IgG antibody detection in individuals with symptoms onset between 15 and 21 days before sample collection. The specificity was 100% in individuals with symptoms onset >15 days before serological tests. This study shows good performance and high level of agreement of three immunoassays for the detection of SARS-CoV-2 antibodies.

scholarly journals Clinical Evaluation of a New Antigen-Based COVID-19 Rapid Diagnostic Test from Symptomatic Patients

Diagnostics ◽  
2021 ◽  
Vol 11 (12) ◽  
pp. 2300
Author(s):  
Saiful Arefeen Sazed ◽  
Mohammad Golam Kibria ◽  
Mohammad Sharif Hossain ◽  
Md Fahad Zamil ◽  
Pranob Chandra Adhikary ◽  
...  
Keyword(s):  
Gold Standard ◽  
Clinical Performance ◽  
Detection System ◽  
Rapid Test ◽  
Test Results ◽  
Rt Pcr ◽  
Test Procedures ◽  
Healthcare Facilities ◽  
The Right ◽  
Current Detection

Accurate diagnosis at the right moment is the prerequisite for treatment of any disease. Failure to correctly diagnose a disease can result in highly detrimental effects, unmistakably a crucial factor during the COVID-19 pandemic. RT-PCR is the gold standard for COVID-19 detection while there are other test procedures available, such as LAMP, X-Ray, and ELISA. However, these tests are expensive, require sophisticated equipment and a highly trained workforce, and multiple hours or even days are often required to obtain the test results. A rapid and cheap detection system can thus render a solution to the screening system on a larger scale and be added as an aid to the current detection processes. Recently, some rapid antigen-based COVID-19 tests devices have been developed and commercialized. In this study, we evaluated the clinical performance of a new rapid detection device (OnSite® COVID-19 Ag Rapid Test by CTK Biotech Inc., Poway, CA, USA) on COVID-19 symptomatic patients (n = 380). The overall sensitivity and specificity were 91.0% (95% CI: 84.8–95.3%) and 99.2% (95% CI: 97.1–99.9), against gold standard RT-PCR. The kit was capable of detecting patients even after 06 days of onset of symptoms and the sensitivity can be maximized to 98% in samples with an average RT-PCR Ct ≤ 26.48, demonstrating a high potential of the kit for clinical diagnosis of symptomatic patients in healthcare facilities.

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