Feasibility Study Of Human Immunodeficiency Virus Antibodies Rapid Diagnostic Tests For Self-testing

ObjectiveBy means of constructing the evaluation panels of blood,OMT and urine HIV RDTs in the laboratory,the performances of blood,OMT and urine HIV RDTs are evaluated.Through On-site research of MSM people the following aspects are evulated,including the ability of using urine,OMT,and blood samples for HIV self-testing operation,the ability to interpret the results of simulated pictures and the ability to understand key information in reagent instructions.And the feasibility of HIV self-testing are explored.MethodsNational reference panel(including blood,OMT,urine HIV antibody reference panel),laboratory evaluation panel(including the laboratory basic panel,the laboratory analytical specificity panel,the laboratory dilution panel,the laboratory precision panel)and HIV-1 Seroconversion Panel are used to evaluate 3 kinds of blood(reagents A1-A3),2 kinds of OMT(reagents B1-B2),1 kind of urine(reagent C)HIV RDTs.Interpret the results visually and read the GOD value by using a gold-labeled immunochromatographic test strip reader.HIV testing points of MSM community organizations were selected as the research site,respectively are in Guiyang City,Guizhou Province and Nanning City,Guangxi Zhuang Autonomous Region.After signing the informed consent,the urine,OMT,and blood HIV self-testing operations were completed independently without any guidance.Then,the questionnaire for the interpretation of the results of urine,OMT,and blood simulation pictures and the key information of the reagent instructions were carried out.The investigator observed and recorded the results throughout the processResults1.Methodological evaluation of rapid detection reagents for HIV antibody in blood/oral mucosal exudate/urineThe coincidence rate of negative reference of 6 reagents is 20/20,the coincidence rate of HIV-1 positive reference is 18/18,and the coincidence rate of HIV-2 positive reference of 3 blood and 2 OMT reagents is 2/2The coincidence rate of positive samples and negative samples of the three blood reagents both are 40/40.For the two OMT reagents,the coincidence rate of positive samples both are 40/40,and the coincidence rate of negative samples are 40/40 and 38/40 respectively.The coincidence rate of positive samples and negative samples of the urine reagents both are 30/30.For the analytical sensitivity,the three blood reagents all are 2/3,and the two OMT reagents are 3/5 and 0/5 respectively,and the urine reagent is 3/5.For the analytical specificity,the three blood reagents all are 45/45,and the two OMT reagents are 45/45 and 36/45 respectively,and the urine reagent is 45/45.There are obvious prozone among the 2 blood reagents(reagent A1,A2),2 OMT reagents and 1 urine reagent.1 blood reagent(reagent A1),1 OMT reagent(reagent B2),and 1 urine reagent(reagent C)have higher precise than other reagents.2.On-site research of non-professionals using HIV antibody rapid tests method to conduct HIV self-testingAmong 326 MSM who completed HIV urine self-testing,85.9%(226/263)are unmarried,77.2%(203/263)are Han nationality,12.2%(32/263)are Zhuang nationality,10.3%(27/263)educated from junior school or below,62.4%(164/263)live in Guizhou Province,35.7%(94/263)live in Guangxi Zhuang Autonomous Region.61 MSM completed HIV OMT self-testing and 17 MSM completed HIV blood self-testing.82.1%(216/263)MSM correctly performed all steps in urine self-testing,11.5%(7/61)in OMT self-testing and 23.5%(4/17)in blood self-testing.For the lowest accuracy among all the steps in the process of urine self-testing,the step(MSM add 3 drops of urine into the sample window of the cassette)was the 88.2%(232/263).The step(MSM gargle before collection)in OMT self-testing is 24.6%(15/61),which was the lowest accuracy.And for the step(MSM wipe for 5-6 seconds),the accuracy are 2%(41/61)and 68.9%(42/61)respectively.And the accuracy of the step(MSM scrape up and down 6-8 times and add 4 drops into the sample window of the cassette)were both 72.1%(44/61).In the process of blood self-test,only 41.2%(7/17)MSM read the results after 30 minutes.The interpretation accuracies of urine,OMT,and blood simulation pictures were 32.7%-98.1%,55.7%-93.4%,and 58.8%-94.1%.The interpretation accuracies for invalid simulated pictures of urine and OMT(without quality control line and with detection line)are 32.7%(54/263)and 55.7%(34/61).The interpretation accuracies of weak reactivity simulated pictures of urine,OMT and blood were 55.9%(147/263),68.9%(42/61),and 58.8%(10/17).The accuracies of understanding key messages in the urine,OMT and blood instructions were 31.6%-80.6%?18.0%-88.5%,0.0%-100.0%.When the test result was reactive,the ratio of further tests in the local CDC/hospital were 84.4%(222/263)? 80.3%(49/61).The result accuracies of self-testing based urine,OMT and blood were 96.9%(255/263),91.8%(56/61)and 100%(17/17).When conducting the second HIV self-testing,54.1%MSM would choose blood test reagent,15.8%would choose blood and urine test reagent,and 14.4%would choose urine test reagent.The reason for choosing blood test reagent was accuracy(57/146)and the reason for choosing urine test reagent was convenience(39/146).Conclusions1.The performance of the three blood HIV rapid test reagents meet the requirements of National Reference Panel for Rapidly Testing Antibodies to Human Immune-deficiency Virus.There are high sensitivities and specificities for them.The reagent A1 and A2 had obvious prozones,while the reagent A3 had no obvious prozones.The reagent A1 have higher precision.2.The performances of reagent B1 meet the requirements of National Reference Panel for Antibodies to Human Immune-deficiency Virus in Human Oral mucosal exudation.The reagent B1 have high sensitivities and specificities.The reagent B1 had false reactivity when testing minimum detection limit reference.And the reagent B1 had false reactivities when testing OMT collected after rinsing,brushing teeth,eating,drinking,and chewing gum.The reagent B1 and B2 both had obvious prozones.The reagent B2 have higher precision.3.The performances of a HIV urine RDTs meet the requirements of National Reference Panel for Antibodies to Human Immune-deficiency Virus in Human Urine.HIV urine RDTs have high sensitivities,specificities and precision4.Compared with blood self-testing and OMT self-testing,MSM can perform urine self-testing operation better.5.When MSM conduct HIV OMT RDTs self-testing,operation errors occur in the preparation,sample collection,sample dilution and sample addition process.When MSM conduct HIV urine RDTs self-testing,the most operation errors occur in the results reading process.When MSM conduct HIV blood RDTs for self-test,more operation error occurs in the sample addition process6.MSM have poor ability to interpret weak reactivity and invalid(no control line/T line,with detection line/C line)simulated pictures.7.MSM has poor ability to understand the key messages in the reagent instructions.8.When conducting the second HIV self-testing,most MSM would choose blood and urine test reagent.The reason for choosing blood test reagent was accuracy and the reason for choosing urine test reagent was convenience.