A comparative laboratory diagnosis of malaria:microscopy versus rapid diagnostic test kits

Objective:To compare the two methods of rapid diagnostic tests(RDTs)and microscopy in the diagnosis of malaria.Methods:RDTs and microscopy were carried out to diagnose malaria. Percentage malaria parasitaemia was calculated on thin films and all non-acute cases of plasmodiasis with less than 0.001%malaria parasitaemia were regarded as negative.Results were simply presented as percentage positive of the total number of patients under study.The results of RDTs were compared to those of microscopy while those of RDTs based on antigen were compared to those of RDTs based on antibody.Patients' follow-up was made for all cases.Results: All the 200 patients under present study tested positive to RDTs based on malaria antibodies(serum)method(100%).128 out of 200 tested positive to RDTs based on malaria antigen(whole blood)method(64%),while 118 out of 200 patients under present study tested positive to visual microscopy of Lieshman and diluted Giemsa(59%).All patients that tested positive to microscopy also tested positive to RDTs based on antigen.All patients on the second day of follow-up were non-febrile and had antimalaria drugs.Conclusions;We conclude based on the present study that the RDTs based on malaria antigen(whole blood)method is as specific as the traditional microscopy and even appears more sensitive than microscopy.The RDTs based on antibody(serum)method is unspecific thus it should not be encouraged.It is most likely that Africa being an endemic region,formation of certain levels of malaria antibody may not be uncommon.The present study also supports the opinion that a good number of febrile cases is not due to malaria. We support WHO's report on cost effectiveness of RDTs but,recommend that only the antigen based method should possibly,be adopted in Africa and other malaria endemic regions of the world.

Evaluation of a Rapid Diagnostic Test, Boson Biotech SARS CoV-2 Ag, for the Detection of SARS-CoV-2 in Gabon

1) Background: Rapid and acurate diagnostic testing for case identification, quarantine, and contact tracing is essential for managing the COVID 19 pandemic. Rapid antigen detection tests are available, however, it is important to evaluate their performances before use. We tested a rapid antigen detection of SARS-CoV-2, based on the immunochromatography (Boson Biotech SARS-CoV-2 Ag Test (Xiamen Boson Biotech Co., Ltd., China)) and the results were compared with the real time reverse transcriptase-Polymerase chain reaction (RT-PCR) (Gold standard) results;2) Methods: From November 2021 to December 2021, samples were collected from symptomatic patients and asymptomatic individuals referred for testing in a hospital during the second pandemic wave in Gabon. All these participants attending “CTA Angondjé”, a field hospital set up as part of the management of COVID-19 in Gabon. Two nasopharyngeal swabs were collected in all the patients, one for Ag test and the other for RT-PCR;3) Results: A total of 300 samples were collected from 189 symptomatic and 111 asymptomatic individuals. The sensitivity and specificity of the antigen test were 82.5% [95%CI 73.8 - 89.3] and 97.9 % [95%CI 92.2 - 98.2] respectively, and the diagnostic accuracy was 84.4% (95% CI: 79.8 - 88.3%). The antigen test was more likely to be positive for samples with RT-PCR Ct values ≤ 32, with a sensitivity of 89.8%;4) Conclusions: The Boson Biotech SARS-CoV-2 Ag Test has good sensitivity and can detect SARS-CoV-2 infection, especially among symptomatic individuals with low viral load. This test could be incorporated into efficient testing algorithms as an alternative to PCR to decrease diagnostic delays and curb viral transmission.

Multiplex Rapid Test with Acceptable Diagnosis Performance as a Solution to Increase Diagnosis of Hepatitis B and C Viruses in Pregnant Women in an Area of High Prevalence of Both Hepatitis Viruses Associated with HIV

Background and Objective: HIV, hepatitis B virus (HBV) and hepatitis C virus (HCV) are very widespread in the world, however, less than 20% of the people affected are diagnosed and treated. This study aimed to determine the prevalence of HIV, HCV and HBV co-infections in pregnant women at Bangui Community University Hospital and the cost of screening. Methods: A cross-sectional study involving consenting pregnant women who came for antenatal care was performed. HIV, HCV antibodies and HBV antigens were detected using Exacto Triplex? HIV/HCV/HBsAg rapid test, cross-validated by ELISA tests. Sociodemographic and professional data, the modes of transmission and prevention of HIV and both hepatitis viruses were collected in a standard sheet and analyzed using the Epi-Info software version 7. Results: Pregnant women aged 15 to 24 were the most affected (45.3%);high school girls (46.0%), and pregnant women living in cohabitation (65.3%) were the most represented. Twenty-five (16.7%) worked in the formal sector, 12.7% were unemployed housewives and the remainder in the informal sector. The prevalence of HIV, HBV, and HCV viruses was 11.8%, 21.9% and 22.2%, respectively. The prevalence of co-infections was 8.6% for HIV-HBV, 10.2% for HIV-HCV, 14.7% for HBV-HCV and 6.5% for HIV-HBV-HCV. All positive results and 10% of negative results by the rapid test were confirmed by ELISA tests. The serology of the three viruses costs 39,000 FCFA (60 Euros) by ELISA compared to 10,000 FCFA (15.00 Euros) with Exacto Triplex? HIV/HCV/AgHBs (BioSynex, Strasbourg, France). Conclusion: The low level of education and awareness of hepatitis are barriers to development and indicate the importance of improving the literacy rate of women in the Central African Republic (CAR). Likewise, the high prevalence of the three viruses shows the need for the urgent establishment of a national program to combat viral hepatitis in the CAR.

Development of a rapid test kit for SARS-CoV-2:an example of product design

We present an example of applying'need-driven'product design principle to the development of a rapid test kit to detect SARS-COV-2(COVID-19).The tests are intended for use in the field and,longer term,for home use.They detect whether a subject is currently infected with the virus and is infectious.The urgent need for large numbers of tests in field setting imposes constraints such as short test time and lack of access to specialist equipment,laboratories and skilled technicians to perform the test and interpret results.To meet these needs,an antigen test based on RT-LAMP with colorimetric readout was chosen.Direct use of swab sample with no RNA extraction was explored.After extensive experimental study(reported elsewhere),a rapid test kit has been fabricated to satisfy all design criteria.

Comparison of Sputum Smear Microscopy and Rapid Tuberculosisantibody Detection Test Kits for Diagnosis of Pulmonary Tuberculosis in Abia State, Nigeria

The SSM （sputum smear microscopy） and five immunochromatographic tuberculosis antibody detection tests （DiaSpot TB, Spodex TB, SD Rapid TB, Clinotech TB Screen and Precious One-step TB） were compared for diagnosis of active TB at the Leprosy and Tuberculosis Referral Hospital, Uzuakoli, Abia State, Nigeria. Sputum specimens from 150 study participants （male/female ratio, 0.81） were cultured on Lowenstein-Jensen slopes and direct smears were stained by Ziehl-Neelsen technique and examined by light microscopy. Sera were tested for anti-TB antibodies using the rapid TB tests. A total of 91 participants were culture positive, 79 （86.8%） for M. tuberculosis and 12 （13.2%） for nontuberculous mycobacteria. The sensitivity of SSM was 50% （95% CI： 39.0-61.0） and specificity was 92.3% （95% CI： 86.4-98.2） in those culture positive for M. tuberculosis. The sensitivity and specificity of the Rapid TB tests ranged from 24.1-39.2% and 78.4-87.8%, respectively. None of the five rapid TB tests had acceptable level of accuracy for diagnosis of active TB. The sensitivity of SSM though moderate is inadequate for long term TB control in this setting.

Evaluation of Three Rapid Diagnostic Test Kits in the Diagnosis of <i>Plasmodium</i>Species Infections among Primary School Children in Baringo County, Kenya

Background: Due to the difficulty in implementing microscopy-based definitive diagnosis of malaria especially in resource-poor areas, rapid diagnostic test (RDT) kits as alternatives have been developed by different companies. Kits from different companies may differ in sensitivity and specificity. It is therefore imperative to conduct field evaluation of kits from different manufacturers before they are recommended for widespread use in diagnosis of malaria. The present study sought to evaluate the performance of malaria RDT kits from two manufacturers against microscopy in detection of Plasmodium spp. infections among primary school children in Baringo County, Kenya. Methods: Two cross-sectional comparative surveys to assess three RDT kits (CareStart HRP-2, SD Bioline Ag-Pf and SD Bioline Ag-Pf/Pan) were conducted on 561 pupils from three primary schools within the Kerio Valley of Baringo County, Kenya. Results: A total of 561 blood samples were tested for Plasmodium spp. within a period of four months. SD Bioline Ag-Pf/ Pan RDT kit had a higher sensitivity (90%) compared to that of CareStart HRP-2 (70%) but this was not statistically significant (McNemar’s χ2 = 0.5, df = 1, p = 0.4795). The sensitivity of SD Bioline Ag-Pf was the same as that of Care Start HRP-2 (82.4%). The number of positive samples by microscopy was relatively lower than those detected by RDT kits. Two cases of non-P. falciparum infections were detected by RDT kits during the second survey. Conclusion: The results of the present study suggest that the performance of the three kits in the diagnosis of P. falciparum infections was better than microscopy. The sensitivity of SD Bioline Ag-Pf/Pan was slightly greater than that of Care Start HRP-2, although not statistically different.

Comparison of Malaria Rapid Diagnostic Test Kit and Microscopy

Malaria is the most common single diagnosis made in many countries in Africa. Microscopy is the gold standard for laboratory diagnosis of malaria parasite, but it requires adequate training and the time to get results is longer than that for Rapid Diagnostic Tests (RDTs). Use of RDTs is an alternative diagnostic method. This method is quick and easy to carry out. This study examined 412 blood samples of patients who met the study inclusion criteria from the health centres. All of the samples obtained were tested by SD Bioline malaria Ag P.f test commonly available in Nigeria and parasite count was done from thick film prepared. The results obtained were presented as a proportion positive in comparison to the total number of participants enrolled. Of the 412 enrollees, 284 were tested positive with malaria using the RDT, 400 were tested positive with microscopy and 12 were negative using microscopy and RDT. This study confirms the superior sensitivity of microscopy to RDTs in diagnosis of malaria. Although RDTs are very useful for quick diagnosis of malaria, particularly in areas where access to the use of microscopy is not available, the possibility of a low performance by RDTs in malaria diagnosis should be emphasized on health practitioners and microcopy should be encouraged as much as possible.

Development and Performance Measurement of Rapid Detection ciELISA Kit for Ractopamine

Mixed anhydride(MA)was used to conjugate ractopamine(RAC)to BSA and obtained artificial antigen BSA-RAC identified by UV and SDS-PAGE.Balb/c mice were immunized with BSA-RAC and hybridoma lines that secrete RAC monoclonal antibody(mAb)were generated with cell fusion.A ciELISA kit for detection of RAC(RAC-Kit)was developed with RAC mAb and its performance were tested.The results indicated that BSA-RAC was successfully synthesized and its conjugation ratio of RAC to BSA was about 24.5∶1.Three hybridoma lines were filtered and the best one was 4D8-3E11,its affinity constant(Ka)was 1.65×1010 L/mol.The limit of detection of RAC-Kit was 0.5 ng/ml and its detection range was 0.5-184 ng/ml.The mean recoveries of RAC spiked in feed were 85.6% and in swine urine were 88.6%.The precision and accuracy of the assay as determined by inter-assay and intra-assay coefficient variation were below 15%.It had 9.4% cross-reactivity(CR%)to dobutamine and little or no CR to other compounds.The validity of RAC-Kit in 4 ℃ was in 180 d.

Dual specimens increase the diagnostic accuracy and reduce the reaction duration of rapid urease test

AIM:To evaluate the influence of multiple samplings during esophagogastr oduodenoscopy(EGD) on the accuracy of the rapid urease test,and the validity of newly developed rapid urease tests,HelicotecUT plus test and HelicotecUT test,CLO test and ProntoDry test.METHODS:A total of 355 patients undergoing EGD for dyspepsia were included.Their Helicobacter pylori(H.pylori) treatment status was either nave or eradicated.Six biopsy specimens from antrum and gastric body,respectively,were obtained during EGD.Single antral specimens and dual(antrum+body) specimens were compared.Infection status of H.pylori was evaluated by three different tests:culture,histology,and four different commercially available rapid urease tests(RUTs)-including the newly developed HelicotecUT plus test and HelicotecUT test,and established CLO test and ProntoDry test.H.pylori status was defined as positive when the culture was positive or if there were concordant positive results among histology,CLO test and ProntoDry test.RESULTS:When dual specimens were applied,sensitivity was enhanced and RUT reaction time was signif icantly reduced,regardless of their treatment status.Thirty minutes were enough to achieve an agreeable positive rate in all the RUTs.Both newly developed RUTs showed comparable sensitivity,specif icity and accuracy to the established RUTs,regardless of patient treatment status,RUT reaction duration,and EGD biopsy sites.CONCLUSION:Combination of antrum and body biopsy specimens greatly enhances the sensitivity of rapid urease test and reduces the reaction duration to 30 min.

Rapid testing methods for food contaminants and toxicants

Food safety is one of the major concerns in every country regardless of the economic and social development. The frequent occurrence of food scandals in the world has led the Chinese government to implement several strategies to fortify the food supply system to a high food safety standard. This relies heavily on laboratory testing services but conventional methods for detection of food contaminants and toxicants are limited by sophisticated sample preparation procedures, long analysis time, large instruments and professional personnel to meet the increasing demands. In this review, we have incorporated most of the current and potential rapid detection methods for many notorious food contaminants and toxicants including microbial agents, toxic ions, pesticides, veterinary drugs and preservatives, as well as detection of genetically modified food genes and adulterated edible oil. Development of rapid, accurate, easy-to-use and affordable testing methods could urge food handlers and the public to actively screen for food contaminants and toxicants instead of passively relying on monitoring by the government examination facility. This review also provides several recommendations including how to encourage the public to engage in the food safety management system and provide optimal education and financial assistance that may improve the current Chinese food safety control system.

Establishment and Preliminary Application of a Rapid Fluorescent Focus Inhibition Test (RFFIT) for Rabies Virus

The World Health Organization (WHO) standard assay for determining levels of the rabies virus neutralization antibody (RVNA) is the rapid fluorescent focus inhibition test (RFFIT), which is used to evaluate the immunity effect after vaccination against rabies. For RFFIT, CVS-11 was used as the challenge virus, BSR cells as the adapted cells, and WHO rabies immunoglobulin (WHO STD) as the reference serum in this study. With reference to WHO and Pasteur RFFIT procedures, a micro-RFFIT procedure adapted to our laboratory was produced, and its specificity and reproducibility were tested. We tested levels of RVNA in human serum samples after immunization with different human rabies vaccines (domestic purified Vero cell rabies vaccine (PVRV) and imported purified chick embryo cell vaccine (PCECV)) using different regimens (Zagreb regimen and Essen regimen). We analyzed the levels of RVNA, and compared the immune efficacy of domestic PVRV and imported PCECV using different immunization regimens. The results showed that the immune efficacy of domestic PVRV using the Zagreb regimen was as good as that of the imported PCECV, but virus antibodies were generated more rapidly with the Zagreb regimen than with the Essen regimen. The RFFIT procedure established in our laboratory will enhance the comprehensive detection ability of institutions involved in rabies surveillance in China.

Comparison of a rapid diagnostic test and microimmunofluorescence assay for detecting antibody to Orientia tsutsugamushi in scrub typhus patients in China

Objective:To evaluate the detection of IgM and IgG antibodies to Orientia tsutsugamushi(O. tsutsugamushi) by rapid diagnostic test(RDT) and microimmunofluorescence assay(ml FA). Methods:RDT using a mixture of recombinant 56-kDa proteins of O.tsutsugamushi and mIFA assay were performed on 20 patients from Fujian and 13 patients from Yunnan Province,and 82 sera samples from healthy farmers in Anhui Province and Beijing City in 2009.Comparison of the RDT and mIFA assay was performed by using X test and the P level of 【0.05 was considered to be significance.Results:Among these 82 normal sera samples,the specificity of RDT was 100%for both IgM and IgG tests.In 33 samples from patients with scrub typhus,5 cases were positively detected earlier by RDT than by mIFA in IgM test,and 2 cases were positive in IgG test.Sensitivities of RDT were 93.9%and 90.9%for IgM and IgG,respectively.The sensitivity of combination lest of IgM and IgG was 100%.Geometric mean titer diluted sera from confirmed cases by IFA and RDT assay were 1:37 vs.1:113(P【0.001) in IgM test and 1:99 vs.1:279 (P【0.05) in IgG test.Conclusions:RDT is more sensitivite than mIFA in the early diagnosis of scrub typhus and it is particularly applicable in rural areas.

Assessment of rapid impact compaction in ground improvement from in-situ testing

Ground improvement has been used on many construction sites to densify granular materials, in other word, to improve soil properties and reduce potential settlement. This work presents a case study of ground improvement using rapid impact compaction （RIC）. The research site comprises the construction of workshop and depots as part of railway development project at Batu Gajah-Ipoh, Malaysia. In-situ testing results show that the subsurface soil comprises mainly of sand and silty sand through the investigated depth extended to 10 m. Groundwater is approximately 0.5 m below the ground surface. Evaluation of improvement was based on the results of pre- and post-improvement cone penetration test （CPT）. Interpretation software has been used to infer soil properties. Load test was conducted to estimate soil settlement. It is found that the technique succeeds in improving soil properties namely the relative density increases from 45% to 70%, the friction angle of soil is increased by an average of 3°, and the soil settlement is reduced by 50%： The technique succeeds in improving soil properties to approximately 5.0 m in depth depending on soil uniformity with depth.

Evaluation of a Direct Rapid Immunohistochemical Test (dRIT) for Rapid Diagnosis of Rabies in Animals and Humans

Presently the gold standard diagnostic technique for rabies is the direct immunofluorescence assay （dFA） which is very expensive and requires a high level of expertise. There is a need for more economical and user friendly tests, particularly for use in developing countries. We have established one such test called the direct rapid immunohistochemical test （dRIT） for diagnosis of rabies using brain tissue. The test is based on capture of rabies nucleoprotein （N） antigen in brain smears using a cocktail of biotinylated monoclonal antibodies specific for the N protein and color development by streptavidin peroxidase-amino ethyl carbazole and counter staining with haematoxollin. The test was done in parallel with standard FAT dFA using 400 brain samples from different animals and humans. The rabies virus N protein appears under fight microscope as reddish brown particles against a light blue background. There was 100 % correlation between the results obtained by the two tests. Also, interpretation of results by dRIT was easier and only required a light microscope. To conclude, this newly developed dRIT technique promises to be a simple, cost effective diagnostic tool for rabies and will have applicability in field conditions prevalent in developing countries.

Value of a new stick-type rapid urine test for the diagnosis of Helicobacter pylori infection in the Vietnamese population

AIM: To assess the value of a new test for the diagnosis of Helicobacter pylori (H. pylori) infection, Rapirun®H. pylori Antibody Stick (Rapirun® Stick), in a Vietnamese population.

Intraprocedural gastric juice analysis as compared to rapid urease test for real-time detection of Helicobacter pylori

BACKGROUND Endofaster is an innovative technology that can be combined with upper gastrointestinal endoscopy(UGE)to perform gastric juice analysis and real-time detection of Helicobacter pylori(H.pylori).AIM To assess the diagnostic performance of this technology and its impact on the management of H.pylori in the real-life clinical setting.METHODS Patients undergoing routine UGE were prospectively recruited.Biopsies were taken to assess gastric histology according to the updated Sydney system and for rapid urease test(RUT).Gastric juice sampling and analysis was performed using the Endofaster,and the diagnosis of H.pylori was based on real-time ammonium measurements.Histological detection of H.pylori served as the diagnostic gold standard for comparing Endofaster-based H.pylori diagnosis with RUT-based H.pylori detection.RESULTS A total of 198 patients were prospectively enrolled in an H.pylori diagnostic study by Endofasterbased gastric juice analysis(EGJA)during the UGE.Biopsies for RUT and histological assessment were performed on 161 patients(82 men and 79 women,mean age 54.8±19.2 years).H.pylori infection was detected by histology in 47(29.2%)patients.Overall,the sensitivity,specificity,accuracy,positive predictive value,and negative predictive value(NPV)for H.pylori diagnosis by EGJA were 91.5%,93.0%,92.6%,84.3%,and 96.4%,respectively.In patients on treatment with proton pump inhibitors,diagnostic sensitivity was reduced by 27.3%,while specificity and NPV were unaffected.EGJA and RUT were comparable in diagnostic performance and highly concordant in H.pylori detection(κ-value=0.85).CONCLUSION Endofaster allows for rapid and highly accurate detection of H.pylori during gastroscopy.This may guide taking additional biopsies for antibiotic susceptibility testing during the same procedure and then selecting an individually tailored eradication regimen.

Comparison of Microscopic Determination and Rapid Diagnostic Tests (RDTs) in the Detection of Plasmodium Infection

Malaria infection is the most common diagnosis made in Africa. Efficient diagnosis of malaria parasite is very vital for treatment of malaria infection. The efficacy of rapid diagnostic tests (RDTs) in comparison to microscopy, the gold standard, in the diagnosis of malaria in Nigeria has not been fully ascertained. This study compared the sensitivity, specificity and predictive values of RDTs available in Nigeria market with microscopy. Two RDT kits were used and their results were compared with the gold standard, microscopy using thick and thin blood films (TBF and tBF). TBF had sensitivity of 85%, specificity of 30%, positive predictive value (PPV) of 55.2%, and negative predictive value (NPV) of 66.6%;tBF had sensitivity of 80%, specificity of 35%, positive predictive value (PPV) of 55.2%, and negative predictive value (NPV) of 63.6%. Among the RDTs, Care Start HRP2 kit had sensitivity of 65%, specificity of 50%, positive predictive value (PPV) of 56.5%, and negative predictive value (NPV) of 59% while SD Bioline kit had sensitivity of 55%, specificity of 65%, PPV of 61%, and NPV of 59%. It can thus be inferred that rapid diagnostic test kits are not as sensitive as microscopy in diagnosis of malaria parasite, but they are more accurate and are thus suitable alternatives to microscopy.

Tire Dynamics Modeling Method Based on Rapid Test Method

Combined with the tire dynamics theoretical model,a rapid test method to obtain tire lateral and longitudinal both steady-state and transient characteristics only based on the tire quasi-steady-state test results is proposed.For steady state data extraction,the test time of the rapid test method is half that of the conventional test method.For transient tire characteristics the rapid test method omits the traditional tire test totally.At the mean time the accuracy of the two method is much closed.The rapid test method is explained theoretically and the test process is designed.The key parameters of tire are extracted and the comparison is made between rapid test and traditional test method.The result show that the identification accuracy based on the rapid test method is almost equal to the accuracy of the conventional one.Then,the heat generated during the rapid test method and that generated during the conventional test are calculated separately.The comparison shows that the heat generated during the rapid test is much smaller than the heat generated during the conventional test process.This benefits to the reduction of tire wear and the consistency of test results.Finally,it can be concluded that the fast test method can efficiently,accurately and energy-efficiently measure the steady-state and transient characteristics of the tire.

Field evaluation of COVID-19 rapid antigen test:Are rapid antigen tests less reliable among the elderly?

BACKGROUND The global outbreak of coronavirus disease 2019(COVID-19)leads to the development of accessible and cost-effective rapid antigen-detection tests(RATs),as quick and accurate diagnosis is crucial to curb the pandemic.AIM To evaluate the Humasis COVID-19 Ag Test(Humasis Co.,Ltd.,Gyeonggi-do,Republic of Korea)in the diagnosis of severe acute respiratory syndrome coronavirus-2(SARS-CoV-2).METHODS This retrospective study was carried out at the Croatian Institute of Public Health and included patients with clinical symptoms of COVID-19 lasting no longer than 5 d prior to testing,whose nasopharyngeal swabs were primarily tested with RAT.Negative RAT samples underwent confirmatory real-time reverse transcription-polymerase chain reaction(RT-PCR).Diagnostic efficacy was determined compared to RT-PCR.The patients were divided into three age groups(<18,19-65,>65 years).Statistical analysis was performed with the significance level set at P<0.05.RESULTSIn total,2490 symptomatic patients were tested;953 samples were positive on RAT,and 1537 werenegative.All negative RAT samples were subjected to RT-PCR;266 samples were positive andmarked as false-negative results on RAT.The calculated negative predictive value as a measure ofRAT efficacy was 82.69%.The χ^(2) test and Kruskal-Wallis test showed a significant difference in theproportion of false negatives(P<0.001)and RT-PCR cycle(Ct)values for false-negative RATs(P=0.012)among the age groups.The young age group was significantly less likely to be falsenegative,whereas the false negatives from the elderly group experienced significantly lower Ctvalues than the other two age groups.CONCLUSIONEvaluated RAT demonstrated satisfactory performance with more reliable results in youngerpatients.Humasis COVID-19 Ag RAT is potentially a valuable tool in areas where access tomolecular methods is limited;however,RT-PCR remains a gold standard for SARS-CoV-2detection.