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Background & objectives: Malaria is a parasitic disease spread by Plasmodium parasite. Microscopy, lateral flow devices such as the Rapid Diagnostic Test (RDT), molecular methods such as Polymerase Chain Reaction (PCR), isothermal methods such as Loop-mediated isothermal amplification (LAMP), and other diagnostic methods are available for malaria. On the other hand, the accuracy of molecular diagnosis is dependent on genomic DNA isolation. A quick method for isolating and subjectively determining the presence of genomic DNA from blood, dried blood spot (DBS), and rapid diagnostic test (RDT), was identified. Methods: We have developed a protocol for isolating DNA from blood, DBS, and RDTs using the HUDSON Buffer (TCEP and EDTA). Isolated genomic DNA was seen with SYBR Safe DNA stain (1X) under a UV transilluminator without running in 0.8 percent gel electrophoresis or using a spectrophotometer. Results: The technique for DNA isolation was accurate for the presence of malaria parasite genomic DNA from positive samples confirmed by microscopy with a sensitivity of 76% and specificity of 78.67% and RDT with a sensitivity of 88% and specificity of 66%. The requirements were minimal, and the process took 30 minutes for a hundred sample processing. Interpretation & conclusion: Finding a fast and reliable method of separating nucleic acids from many samples is crucial. This approach extracts intact genomic DNA in under ten minutes, making it ideal for large-scale investigations.

Background & objectives: India targets malaria elimination by 2030 in a phased manner, so malaria's assured diagnosis is crucial. Introduction of rapid diagnostic kits in India in 2010 has revolutionized malaria surveillance. The storage temperature of rapid diagnostic tests (RDTs), kit components and handling in transportations impact the results of RDTs. Therefore, quality assurance (QA) is required before it reaches end-users. The Indian Council of Medical Research-National Institute of Malaria Research (ICMR-NIMR) has a World Health Organization (WHO) recognized lot-testing laboratory facility to assure the quality of RDTs. Methods: The ICMR-NIMR receives RDTs from different manufacturing companies as well as various agencies such as National and State Programmes and Central Medical Services Society. The WHO standard protocol is followed to conduct all the tests, including long-term and post-dispatch testing. Results: A total of 323 lots tested during January 2014-March 2021 were received from different agencies. Amongst them, 299 lots passed the quality of test and 24 failed. In long-term testing, 179 lots were tested and only nine failed. A total of 7741 RDTs were received from end-users for post-dispatch testing of which 7540 qualified the QA test with a score of 97.4 per cent. Interpretation & conclusions: RDTs received for quality testing showed compliance with QA evaluation of malaria RDTs based on the protocol recommended by the WHO. However, continuous monitoring of the quality of RDTs is required under QA programme. Quality-assured RDTs have a major role, especially in areas where low parasitaemia of parasites persists.

The contamination of oat crops by trichothecene mycotoxins, T-2 and HT-2 is an ongoing threat to our food safety. Within the industry, there are increasing concerns about the continued and growing presence of these mycotoxins occurring in oat crops due to climate change, farming practices and the handling of crops post-harvest. To safeguard human health, monitoring these mycotoxins in foodstuffs is paramount to ensure human exposure is limited. To achieve this, effective testing regimes must be established within the industry, consisting not only of rapid, reliable, and accurate analytical methods but also efficient sampling strategies. Four commercial rapid diagnostic kits were assessed against liquid chromatography coupled to mass spectrometry and included three lateral flow devices and one enzyme-linked immunosorbent assay. One-way ANOVA showed a p-value of 0.45 indicating no significant difference between the methods assessed. Qualitative analysis revealed test kits 1, 2, 3, and 4 showed false negative/false positive rates of 1.1/2.2, 7.6/0, 2.2/0, and 6.5/0 percent, respectively. Test Kit 1, the Neogen Reveal® Q+ MAX for T-2/HT-2 Kit provided the most reliable, accurate and cost-effective results. Furthermore, its ease of use and no requirement for technical skill makes it applicable for on-site testing.

Background & objectives: Rapid diagnostic test (RDT) kits are widely used in India for the diagnosis of dengue infection. It is important to evaluate the validity and reliability of these RDTs. The study was aimed to determine the sensitivity, specificity and predictive value of four commercially available RDTs [Panbio Dengue Duo cassette, Standard Diagnostics (SD) Bioline Dengue Duo, J. Mitra Dengue Day-1 test and Reckon Dengue IgG/IgM] against composite reference criteria (CRC), and compare the cost of the tests. Methods: In this prospective observational study for diagnostic accuracy, we tested stored blood samples from 132 cases of dengue and 149 controls of other infections as classified based on CRC, with all the four RDTs. The CRC was based on the epidemiological considerations, common clinical features and laboratory abnormalities. The non-dengue controls were the cases of proven alternative diagnosis. The diagnostic performances of the tests were compared in terms of sensitivity, specificity and predictive value along with the cost involved per test. Results: The sensitivity of the Panbio and SD RDT kits was found to be 97.7 and 64.3% respectively, and the specificities were 87.8 and 96.6% respectively. The sensitivity of the NS1 antigen capture by SD Duo, Reckon, J. Mitra RDTs was 20.9, 18.6 and 27.1% respectively. The prevalence of dengue specific IgG antibody with Panbio RDT kits was 49.3%. The cost per test for Panbio, SD, Reckon and J. Mitra is US$ 6.90, 4.27, 3.29 and 3.61 respectively. Conclusion: It was concluded that in dengue outbreak, Panbio IgM capture RDT alone is reliable and easily available test which can be used in acute phase of dengue infection in any resource limited set up. NS1 capture rates by any of the other three RDTs might not be reliable for the diagnosis of acute dengue infection.

With India aiming to achieve malaria elimination by 2030, several strategies have been put in place. With that aim, mass surveillance is now being conducted in some malaria-endemic pockets. As dry season mass surveillance has been shown to have its importance in targeting the reservoir, a study was undertaken to assess the parasite load by a sensitive molecular method during one of the mass surveys conducted in the dry winter period. It was executed in two malaria-endemic villages of Dhalai District, Tripura, in northeast India, also reported as P. falciparum predominated area. The present study found an enormous burden of Rapid Diagnostic Test negative malaria cases with P. vivax along with P. vivax and P. falciparum mixed infections during the mass surveillance from febrile and afebrile cases in dry winter months (February 2021–March 2021). Of the total 150 samples tested, 72 (48%) were positive and 78 (52%) negative for malaria by PCR. Out of the 72 positives, 6 (8.33%) were P. falciparum, 40 (55.55%) P. vivax, and 26 (36.11%) mixed infections. Out of 78 malaria negative samples, 6 (7.7%) were with symptoms, while among the total malaria positive, 72 cases 7 (9.8%) were with symptoms, and 65 (90.2%) were asymptomatic. Out of 114 samples tested by both microscopy and PCR, 42 samples turned out to be submicroscopic with 4 P. falciparum, 23 P. vivax, and 15 mixed infections. Although all P. vivax submicroscopic infections were asymptomatic, three P. falciparum cases were found to be febrile. Evidence of malaria transmission was also found in the vectors in the winter month. The study ascertained the use of molecular diagnostic techniques in detecting the actual burden of malaria, especially of P. vivax, in mass surveys. As Jhum cultivators in Tripura are at high risk, screening for the malarial reservoirs in pre-Jhum months can help with malaria control and elimination.

While molecular techniques remain the gold standard for diagnosis of acute SARS-CoV-2 infection, serological tests have the unique potential to ascertain how much of the population has been exposed to the COVID-19 pathogen. There have been limited published studies to date documenting the performance of SARS-CoV-2 antibody assays in Nigeria and so we evaluated the diagnostic performance of five (5) immunoassay on a set of clinical samples. Five automated immunoassays (2019-nCoV IgG/IgM antibody determination kit, Tigsun COVID-19 combo IgM/IgG rapid test, rapid response COVID-19 IgG/IgM test, COVID-19 IgM-IgG combined antibody rapid test, iChroma COVID-19 Ab) were tested. Three hundred and fourteen specimens were analyzed from health care workers who tested positive PCR for SARS-CoV-2 with symptoms consistent with SARS-CoV-2 receiving treatment at two treatment centres in Nasarawa State from March to September, 2020 with control of 134 health care workers who tested negative PCR for SARS-CoV-2 with no symptoms to SARS-CoV-2. The median patients' age was 40 years (IQR 39.8-41), majority were male and were on admission. The SARS-CoV-2 IgG/IgM antibody evaluated kits had a sensitivity of 33% (2019-nCoV IgG/IgM antibody determination kit), 22% (Tigsun COVID-19 combo IgM/IgG rapid test), 43% (rapid response COVID-19 IgG/IgM test), 44% (COVID-19 IgM-IgG combined antibody rapid test), 25% (iChroma COVID-19 Ab), 100% sensitivity, accuracy of 68.5% and Kappa coefficient of 0.7 and rapid response COVID-19 IgG/IgM test cassette had a sensitivity of 33%, specificity of 100% and accuracy of 72.5% with Kappa coefficient 0.7. The Tigsun COVID-19 combo IgM/IgG rapid test (lateral flow), positive, COVID-19 IgM-IgG combined antibody rapid test and iChroma COVID-19 Ab RT all had sensitivity of zero percent. Serology was complementary to RT-PCR for the diagnosis of COVID-19 at least 14 days after onset of symptoms. The assay panel needs to be improved to serve as an option for the diagnosis of SARS-CoV-2 in resource constrained settings where there are limited molecular diagnostics testing panels.While molecular techniques remain the gold standard for diagnosis of acute SARS-CoV-2 infection, serological tests have the unique potential to ascertain how much of the population has been exposed to the COVID-19 pathogen. There have been limited published studies to date documenting the performance of SARS-CoV-2 antibody assays in Nigeria and so we evaluated the diagnostic performance of five (5) immunoassay on a set of clinical samples. Five automated immunoassays (2019-nCoV IgG/IgM antibody determination kit, Tigsun COVID-19 combo IgM/IgG rapid test, rapid response COVID-19 IgG/IgM test, COVID-19 IgM-IgG combined antibody rapid test, iChroma COVID-19 Ab) were tested. Three hundred and fourteen specimens were analyzed from health care workers who tested positive PCR for SARS-CoV-2 with symptoms consistent with SARS-CoV-2 receiving treatment at two treatment centres in Nasarawa State from March to September, 2020 with control of 134 health care workers who tested negative PCR for SARS-CoV-2 with no symptoms to SARS-CoV-2. The median patients' age was 40 years (IQR 39.8-41), majority were male and were on admission. The SARS-CoV-2 IgG/IgM antibody evaluated kits had a sensitivity of 33% (2019-nCoV IgG/IgM antibody determination kit), 22% (Tigsun COVID-19 combo IgM/IgG rapid test), 43% (rapid response COVID-19 IgG/IgM test), 44% (COVID-19 IgM-IgG combined antibody rapid test), 25% (iChroma COVID-19 Ab), 100% sensitivity, accuracy of 68.5% and Kappa coefficient of 0.7 and rapid response COVID-19 IgG/IgM test cassette had a sensitivity of 33%, specificity of 100% and accuracy of 72.5% with Kappa coefficient 0.7. The Tigsun COVID-19 combo IgM/IgG rapid test (lateral flow), positive, COVID-19 IgM-IgG combined antibody rapid test and iChroma COVID-19 Ab RT all had sensitivity of zero percent. Serology was complementary to RT-PCR for the diagnosis of COVID-19 at least 14 days after onset of symptoms. The assay panel needs to be improved to serve as an option for the diagnosis of SARS-CoV-2 in resource constrained settings where there are limited molecular diagnostics testing panels.

Orientia tsutsugamushi is responsible for causing scrub typhus (ST) and is the leading cause of acute encephalitis syndrome (AES) in AES patients. A rapid and sensitive method to detect scrub typhus on-site is essential for the timely deployment of control measures. In the current study, we developed a rapid, sensitive, and instrument-free lateral flow assay (LFA) detection method based on CRISPR/Cas12a technology for diagnosing ST (named LoCIST). The method is completed in three steps: first, harnessing the ability of recombinase polymerase for isothermal amplification of the target gene; second, CRISPR/Cas12a-based recognition of the target; and third, end-point detection by LFA. The detection limit of LoCIST was found to be one gene copy of ST genomic DNA per reaction, and the process was complete within an hour. In 81 clinical samples, the assay showed no cross-reactivity with other rickettsial DNA and was 100% consistent with PCR detection of ST. LoCIST demonstrated 97.6% sensitivity and 100% specificity. Overall, the LoCIST offers a novel alternative for the portable, simple, sensitive, and specific detection of ST, and it may help prevent and control AES outbreaks due to ST. In conclusion, LoCIST does not require specialized equipment and poses a potential for future applications as a point-of-care diagnostic.

In this study, we assessed the correlations between hemoglobin A1c (HbA1c) measurements obtained using three different diagnostic methods, namely reversed-phase cation-exchange chromatography, high-performance liquid chromatography, and lateral flow immunoassay (LIFA) with an AnyLab F instrument. HbA1c levels measured with the AnyLab F instrument and those measured with the HA8190V, HA8180, and D100 instruments were strongly correlated. High R-square values and low p-values indicated significant and reliable correlations, supporting the clinical interchangeability of these methods. Notably, demographic and clinical analyses revealed uniform HbA1c levels across age groups, suggesting minimal age-related variations in HbA1c levels in the cohort. This finding has implications for diabetes management strategies across different age groups, emphasizing the versatility of the AnyLab F instrument. Overall an average HbA1c level of 7.857% among diabetes mellitus-diagnosed participants suggests moderately elevated HbA1c levels, underscoring the need for improved diabetes management. Younger individuals exhibited lower HbA1c levels, potentially owing to heightened awareness and treatment plan adherence. Conversely, older adults had higher HbA1c levels, likely influenced by age-related changes and comorbidities. Larger sample sizes and a comprehensive evaluation of various measurement principles are needed to strengthen the findings herein. Additionally, exploring additional biomarkers and assessing LIFA performance in larger sample sets will advance the clinical utility of HbA1c measurements.

Background and Objectives: In patients with congestive heart failure, brain natriuretic peptide (BNP) and N-terminal prohormone of brain natriuretic peptide (NT-proBNP) are released due to excessive heart muscle expansion; they can be used for the early detection, progress monitoring, and treatment of congestive heart failure. Recently, considerable efforts have been made to develop an NT-proBNP-based biomarker for detecting heart failure. This study attempts to develop a rapid and accurate congestive heart failure diagnostic kit using NT-proBNP. Materials and Methods: A new gene based on NT-proBNP was selected, recombined, and expressed in Escherichia coli strains, and then monoclonal antibodies were produced using the hybridoma technique. Additionally, antigen-antibody reactivity was confirmed using indirect enzyme-linked immunosorbent assay (ELISA). Furthermore, the first pair and full-strip pair tests were conducted to select candidate clones; these were applied to a rapid diagnosis kit based on gold conjugates and compared with other currently available antigens. Results: NT-proBNP-based antigens with high specificity and monoclonal antibodies were produced, and the optimal antigen-antibody reactivity was confirmed using indirect ELISA. The first pair and full-strip pair tests were performed to select the optimal candidate clones, and a rapid diagnosis kit with excellent reactivity was developed by applying these to a rapid diagnosis kit based on gold conjugates. Conclusions: The development of this rapid diagnosis kit with excellent performance in congestive heart failure is expected to improve disease management by providing an early assessment of the risk of heart failure.