Evaluation of serological tests for the diagnosis of tuberculosis

To evaluate the use of antibody detection kits in the diagnosis of pulmonary tuberculosis in an endemic area, serum samples from cases (sputum smear positive for AFB) and controls (healthy young adults) were collected and tested using five different kits. Sensitivity, specificity and predictive values were calculated using smear positivity as gold standard. Sensitivity of tests varied from 46% to 68% and the specificity from 68% to 100%. None of the kits evaluated can be used as a single screening test for tuberculosis. However kits with good specificity may be used in conjunction with conventional methods for diagnosis.     

Predicting human immunodeficiency virus type 1-positive sera by using two enzyme immunoassay kits in a parallel testing format.

Two algorithms for screening sera for antibody to human immunodeficiency virus type 1 were compared for their efficiency in identifying a true-positive sample in a population with heterogeneous risk factors, using the criteria of specificity and positive predictive value (PPV). In the first algorithm, all sera were screened by using a single enzyme immunoassay (EIA) kit, and a specificity of 98.6% and a PPV of 69.3% was calculated for true-positive sera. The second algorithm employed two different EIA kits in parallel to screen each sample. In the first instance, a specificity and a PPV of 100% was calculated if a positive sample was defined as reactive by both EIA kits; in the second, a specificity of 99.97% and a PPV of 99.4% was obtained if this criterion was extended to include a combination of one reactive and one equivocal result obtained with the two EIA kits.     

HBsAg ELISA试剂盒筛检结果的评估

目的 评估部分国产与进口HBsAg ELISA试剂盒筛查血源的价值.方法 选用部分国产和进口HBsAg ELISA试剂,对中国生物制品检定所120份HBsAg临床科研组合血清样本及随机抽取400份东莞市无偿献血者血清标本为验证样本进行同步平行检测,以中国生物制品检定所组合血清及献血者HBsAg阳性并经中和试验证实者为金标准.结果采用四格表法计算两者对等指标并进行评价.结果 国产HBsAg ELISA试剂和进口HBsAg ELISA试剂的灵敏度分别为85.71%（72/84）和100%（84/84）;特异性分别为100%（436/436）和96.55%（421/436）;尤登指数分别为0.86、0.97;两种试剂重复合格率均为100%.结论 试剂的灵敏度以进口HBsAg ELISA试剂较好,但特异性比国产试剂差,两种试剂的重复性均好,两种试剂联合筛检献血者血样标本可提高临床输血的安全性.     

Evaluation of nine immunoassay kits (enzyme immunoassay and direct fluorescence) for detection of Giardia lamblia and Cryptosporidium parvum in human fecal specimens.

It is well known that Giardia lamblia and Cryptosporidium parvum can cause severe symptoms in humans, particularly those who are immunologically compromised. Immunoassay procedures offer both increased sensitivity and specificity compared to conventional staining methods. These reagents are also helpful when screening large numbers of patients, particularly in an outbreak situation or when screening patients with minimal symptoms. The data obtained by using 9 diagnostic kits were compared: direct fluorescent-antibody assay (DFA) kits (TechLab Giardia/Crypto IF kit, TechLab Crypto IF kit, and Meridian Merifluor Cryptosporidium/Giardia) and enzyme immunoassay (EIA) kits (Alexon ProSpecT Giardia EZ Microplate Assay, Alexon ProSpecT Cryptosporidium Microplate Assay, Cambridge Giardia lamblia Antigen Microwell ELISA, Meridian Premier Giardia lamblia, Meridian Premier Cryptosporidium, TechLab Giardia CELISA, Trend Giardia lamblia EIA). The test with the Meridian Merifluor Cryptosporidium/Giardia kit was used as the reference method. In various combinations, 60 specimens positive for Giardia, 60 specimens positive for Cryptosporidium, 40 specimens positive for a Giardia-Cryptosporidium mix, and 50 negative fecal specimens were tested. Different species (nine protozoa, three coccidia, one microsporidium, five nematodes, three cestodes, and one trematode) were included in the negative specimens. The sensitivity of EIA for Giardia ranged from 94% (Alexon) to 99% (Trend and Cambridge); the specificity was 100% with all EIA kits tested. The sensitivity of EIA for Cryptosporidium ranged from 98% (Alexon) to 99% (Meridian Premier); specificities were 100%. All DFA results were in agreement, with 100% sensitivity and specificity; however, the TechLab reagents resulted in fluorescence intensity that was generally one level below that seen with the reagents used in the reference method. In addition to sensitivity and specificity, factors such as cost, simplicity, ease of interpretation of results (color, intensity of fluorescence), equipment, available personnel, and number of tests ordered are also important considerations prior to kit selection.     

丙型肝炎病毒抗体酶标试剂盒的评价

目的了解国内丙型肝炎病毒抗体酶标诊断试剂盒的质量。方法应用中国国家丙型肝炎病毒抗体参考品及美国ＢＢＩＡｎｔｉ－ＨＣＶｐａｎｅｌ对Ａｂｂｏｔ等四家国外及六家国内丙型肝炎病毒抗体试剂盒进行了评价。结果１９８份中国国家丙型肝炎病毒抗体参考品中的１００份阳性参考品的检出率，Ａｂｂｏｔ试剂盒为９８％，国产试剂盒为９５％～９７％。对２５份ＢＢＩｐａｎｅｌ中的２３份阳性血清，ｐａｎｅｌ检出率Ａｂｂｏｔ等国外试剂盒为８７％～１００％，国产试剂盒为７０％～９１％。结论国产试剂盒所用丙型肝炎病毒抗原结构区抗原与国外试剂一致，但非结构区抗原较弱。提高国产丙型肝炎病毒抗体试剂盒的质量，应增加高质量的非结构区抗原的应用     

Evaluation of five monoclonal antibody-based kits or reagents for the identification and culture confirmation of herpes simplex virus.

Five immunofluorescence (IF) kits or reagents (Bartels [Bartels Immunodiagnostic Supplies, Inc., Bellevue, Wash.], Imagen [CellTech Diagnostics, Ltd., distributed by Analytab Products, Plainview, N.Y.], Ortho [Ortho Diagnostics Systems, Inc., Raritan, N.J.], Syva [Syva Co., Palo Alto, Calif.], Whittaker [Whittaker Bioproducts, Walkersville, Md.]) were evaluated for typing and laboratory confirmation of herpes simplex virus (HSV). Of 101 clinical isolates tested by each kit or reagent, results for 97 of them were in agreement. Identification of the four isolates with discordant results was performed by restriction endonuclease analysis of the viral DNA. The sensitivity and specificity of the Imagen and Bartels kits were 100%. For the Ortho, Syva, and Whittaker kits or reagents, the HSV type 1 (HSV-1) and HSV type 2 (HSV-2) sensitivities were 97.4 and 100%, 100 and 100%, and 97.4 and 100%, respectively, and the specificities were 100 and 97.4%, 100 and 92.4%, and 100 and 97.4%, respectively. There was one false-positive HSV-2 isolate identified by each of the Ortho and Whittaker kits or reagents. Three false-positive HSV-2 isolates occurred by staining with Syva, giving the erroneous indication of dual isolates. Several isolates stained with Imagen and Whittaker reagents displayed dull IF patterns. A dull green background occurred in ca. one-third of the HSV-2 isolates tested with the Ortho kit. The intensities of IF staining by the Bartels and Syva kits were satisfactory; however, the latter displayed a specificity of 92.7%. A total of 38 and 63 specimens were finally designated as HSV-1 and HSV-2, respectively. Identification of each isolate with the Bartels kit was consistently interpretable and is recommended as the typing and confirmatory assay of choice.     

Evaluation of six commercial kits for detection of human immunoglobulin M antibodies to Toxoplasma gondii. The FDA Toxoplasmosis Ad Hoc Working Group.

As a result of reports received by the Food and Drug Administration (FDA) of false-positive results obtained with FDA-cleared in vitro diagnostic kits for the detection of Toxoplasma-specific human immunoglobulin M (IgM) antibodies, an FDA-sponsored evaluation of six kits was performed. A battery of 258 serum specimens, including 30 specimens drawn 1 to 5 months after initial Toxoplasma infection and 228 specimens from Toxoplasma IgG-positive individuals, Toxoplasma IgG-negative individuals, rheumatoid factor-positive persons, and persons determined to be Toxoplasma IgM positive by commercially available assays, was assembled, randomly assorted, and coded. The battery was tested at the FDA with six commercially available kits, at the Palo Alto Medical Foundation (PAMF) by the PAMF double-sandwich IgM enzyme-linked immunosorbent assay (PAMF IgM ELISA), and at the Centers for Disease Control and Prevention (CDC) by the CDC EIA IgM. The results of the PAMF IgM ELISA that were obtained with the battery were considered to be the "gold standard" for this study; specificity rates were computed by considering the PAMF results to be 100% specific. Sensitivity and specificity rates were found to be as follows: CDC EIA IgM, 100 and 99.1%, respectively; Abbott IMx Toxo IgM, version 1, 100 and 77.5%, respectively; Abbott IMx Toxo IgM, version 2, 93.3 and 97.3%, respectively; Abbott Toxo-M EIA, 100 and 84.2%, respectively; BioMérieux Vitek VIDAS Toxo IgM, 100 and 98.6%, respectively; BioWhittaker Toxocap-M, 100 and 95.9%, respectively; Gull Toxo IgM, 97 and 85.6%, respectively; and Sanofi Diagnostics Pasteur Platelia Toxo IgM, 100 and 96.8%, respectively. Although the extent of false-positive reactions with these kits cannot be calculated because the study was retrospective and sample choices were biased, the results may be useful as an indicator of the relative specificities of these kits.     

HBsAg diagnostic kits in the detection of hepatitis B virus mutation within "a" determinant

The performance of currently available hepatitis B surface antigen (HBsAg) commercial kits was analyzed by using a panel of 212 well-characterized plasma donors all over the country and a panel of nine recombinant HBsAg mutants containing single point or combinations of mutations between amino acid residues 124 and 147 of the "a" determinant. HBsAg commercial kits in this study were machine-based immunoassays with a one-step sandwich ELISA method using either an automatic closed system or manual system. The sensitivity of all machine-based assays evaluated with 105 HBsAg plasma panels was 100% (95% CL = 95.6-99.9%), whereas the specificity with 107 HBsAg negative plasma ranged from 99.07% to 100% (95% CL = 94.2-99.9%). The relative performance of these kits to detect the hepatitis B virus (HBV) mutant panel members of the "a" determinant was found to differ. Interestingly, any commercial kits with monoclonal antibody capture and polyclonal antibody detection (mono/poly), but not mono/mono Ab capture and detection, could pick up the common HBsAg Gly145Arg mutant either solely or in combination with other mutations within the "a" determinant. New versions of HBsAg test kits should recognize multiple HBsAg epitopes in order to detect mutant HBsAg, together with providing good analytical sensitivity and specificity, because of the importance of these assays in HBV diagnosis and in protecting the safety of the blood supply.     

Development and testing of monoclonal antibody-based rapid immunodiagnostic test kits for direct detection of Vibrio cholerae O139 synonym Bengal.

We report on the development and testing of two monoclonal antibody-based rapid immunodiagnostic test kits, BengalScreen, a coagglutination test, and Bengal DFA, a direct fluorescent-antibody test, for direct detection of Vibrio cholerae O139 synonym Bengal in clinical and environmental specimens. The BengalScreen test requires less than 5 min to complete and can be used in the field. Bengal DFA, being more sensitive than BengalScreen, requires only one reagent and less than 20 min for detection and enumeration of V. cholerae O139 synonym Bengal. In tests for specificity, all 40 strains of V. cholerae O139 reacted with both test kits, whereas 157 strains of heterologous species examined did not, yielding 100% specificity in this study. A field trial was conducted in with both BengalScreen and Bengal DFA, and the results were compared with those obtained by conventional culture methods. BengalScreen demonstrated a sensitivity of 95%, a specificity of 100%, a positive predictive value of 100%, and a negative predictive value of 94%. Results obtained by Bengal DFA, on the other hand, were 100% sensitive and 100% specific and yielded 100% positive and negative predictive values compared with culture methods. In a second evaluation, 93 stool specimens from Mexico that were negative for V. cholerae O139 by culture were also tested with both the BengalScreen and Bengal DFA kits. None of the 93 specimens were positive for V. cholerae O139 by both tests. A concentration method was optimized for screening of environmental water samples for V. cholerae O139 synonym Bengal with rapid test kits. BengalScreen results were unequivocally positive when water samples contained at least 2.0 x 10(3) CFU/ml, whereas Bengal DFA demonstrated an unequivocally positive reaction when the water sample contained at least 1.5 x 10(2) CFU/ml. When Bengal DFA was compared with conventional culture methods for enumeration of V. cholerae O139 synonym Bengal organisms, no difference was observed.     

Comparison of seven commercial kits for detection of antibodies toBorrelia burgdorferi

Five enzyme immunoassay (EIA) and two Western blot (WB) commercial kits were compared for their ability to detect antibodies toBorrelia burgdorferi. The panel of 53 test sera consisted of 25 sera positive for antibodies toBorrelia burgdorferi, 15 sera negative for such antibodies, 5 sera reactive in serologic tests for syphilis, and 8 sera containing antinuclear antibodies and/or rheumatoid factor. The rate of agreement with reference results was 93 %, 90 %, 90 % and 88 % for EIA kits from Diamedix, Cambridge Biotech, Mardx and Sigma respectively. The sensitivity and specificity was 84 % and 100 % respectively for Cambridge Biotech, 76 % and 94 % for Diamedix, 68 % and 83 % for Mardx, and 68 % and 83 % for Sigma. The three confirmatory tests, Cambridge Biotech WB, General Biometrics P39 EIA and Mardx WB, demonstrated 75 %, 60 % and 63 % agreement respectively. The sensitivity and specificity was 52 % and 100 % respectively for Cambridge Biotech WB, 24 % and 100 % for General Biometrics P39 EIA, and 44 % and 100 % for Mardx WB. The results demonstrate the variable performance of commercial serologic kits for detection of antibodies toBorrelia burgdorferi. WB appears to be a better confirmatory test than the single protein EIA.     

Streptococcus grouping latex kits: evaluation of five commercially available examples

This study compares a recently introduced latex agglutination test for the serogrouping of beta-haemolytic streptococci against four internationally used commercial kits. The new kit is Prolex-Blue (Pro-Lab Diagnostics) and the comparators are Streptex (Murex), PathoDx (DPC), Streptococcus Grouping kit (Oxoid) and Prolex-White (Pro-Lab Diagnostics). A total of 302 consecutive clinical isolates are tested against all five kits, following the individual manufacturer's protocol, for both accuracy and speed. In addition, the data produced permits determination of the strengths or weaknesses of the kits against individual serotypes. Prolex-Blue proved to be both accurate and rapid, with a sensitivity of 99% and a specificity of 100%. Furthermore, average time to agglutination was substantially less than achieved by three of the other four kits evaluated.     

Comparison of five techniques to detect anti-Saccharomyces cerevisiae antibodies (ASCA) in serum for diagnosing Crohn's disease

OBJECTIVE: the anti-Saccharomyces cerevisiae antibodies (ASCA) are diagnostic markers found in Crohn's disease patients. The aim of this study was to compare three Elisa (enzyme linked immunosorbent assay) kits with the indirect immunofluorescence (IFI) technique and an immunodot for ASCA detection. MATERIALS AND METHODS: we compared the results obtained using IFI (IgA and IgG) and Elisa (IgA and IgG) in 139 patients (37 Crohn's disease). An immunodot (IgA+IgG) was tested in a sub-group of 24 patients (18 Crohn's disease). RESULTS AND DISCUSSION: for the different techniques by Elisa (IgA or IgG), the sensitivity ranged from 65% to 76%, the specificity from 88% to 98%, the positive predictive value (PPV) from 84% to 94% and the negative predictive value (NPV) from 88% to 93%. For IFI, the sensitivity was 81%, the specificity 100%, the PPV 100% and the NPV 93%. The immunodot showed a specificity and PPV of 100% and NPV of 33%. CONCLUSION: the detection of the ASCA is useful in the diagnosis of Crohn's disease. IFI appears as the method of choice for its excellent sensitivity and specificity, and affordable costs.     

Comparison of commercial kits for detection of cryptococcal antigen.

Although kits to detect cryptococcal antigen are used widely to diagnose cryptococcal infection, the comparative performance of commercially available assays has not been evaluated in the past decade. Therefore, we compared the sensitives and specificities of five commercially available kits for detecting cryptococcal antigen (four latex agglutination test kits--Calas [Meridian Diagnostics])--Crypto-LA [International Biological Labs], Myco-Immune [MicroScan], and Immy [Immunomycologics]--and an enzyme immunoassay kit, Premier [Meridian Diagnostics]) with culture for the diagnosis of cryptococcal meningitis and fungemia. Of 182 cerebrospinal fluid (CSF) and 90 serum samples submitted for cryptococcal antigen and fungal culture, 49 (19 and 30 samples, respectively) from 20 patients had a culture positive for Cryptococcus neoformans. For CSF specimens, the sensitivities and specificities of all kits were comparable (sensitivity, 93 to 100%; specificity, 93 to 98%). There was a significant difference in sensitivities of the kits when serum samples were tested with the International Biological Labs and MicroScan kits, which do not pretreat serum with pronase. These kits were less sensitive (sensitivity, 83%) than the Immy and Meridian latex kits (sensitivity, 97%), which do pretreat with pronase. The sensitivity of the Meridian enzyme immunoassay kit was comparable to that of the pronase-containing latex kits. These kits were of equivalent specificities (93 to 100%) when testing serum. Some of the currently available kits have limitations that need to be recognized for proper interpretation of results. Specifically, the use of pronase on serum samples reduces the number of false-positive results, and a titer of < or = 1:4 can be a false-positive result when CSF samples are being tested.     

Commercial latex agglutination tests for detection of Haemophilus influenzae type b and Streptococcus pneumoniae antigens in patients with bacteremic pneumonia.

The validity of commercial latex agglutination kits for detection of Haemophilus influenzae type b and Streptococcus pneumoniae antigens in serum and urine specimens was studied. We tested serum and urine specimens from 44 patients with bacteremic pneumonia (23 S. pneumoniae, 13 H. influenzae type b, 11 other) with commercial latex agglutination kits (Directigen, Bactigen) for S. pneumoniae and H. influenzae type b antigens. All specimen samples were randomized and read blindly by two readers. Interreader reproducibility was 100%. The sensitivity and specificity of both kits for H. influenzae type b antigens in serum and urine were greater than 90%. None of the 24 urine samples from S. pneumoniae bacteremic patients were positive by either kit, although 6 ng of type 3 polysaccharide could be detected in spiked urine. Sensitivity for S. pneumoniae antigens in serum was 27% for Directigen and 38% for Bactigen. Specificity for S. pneumoniae antigens in serum was 95% for Directigen and 74% for Bactigen. The results suggest that the kits are useful in diagnosing H. influenzae type b pneumonia. However, the commercially available S. pneumoniae reagents tested appear to have limited utility for diagnosing S. pneumoniae pneumonia because both kits lack sensitivity and Bactigen lacks specificity, as well.     

Diagnostic usefulness of antineutrophil cytoplasmic autoantibody serology. Comparative evaluation of commercial indirect fluorescent antibody kits and enzyme immunoassay kits

Antineutrophil cytoplasmic autoantibodies (ANCAs) are increasingly used as serologic markers for pauci-immune crescentic glomerulonephritis and small vessel vasculitis. Many hospital laboratories and referral laboratories use commercial assay kits to detect ANCAs, despite inadequate documentation in the medical literature of kit performance. We evaluated the diagnostic sensitivity, specificity, and predictive value of 3 commercial indirect immunofluorescence assay (IFA) kits and 7 commercial enzyme immunoassay (EIA) kits for several ANCA subtypes. Serum samples from 396 patients with a variety of renal diseases were analyzed, including 146 patients with pauci-immune crescentic glomerulo-nephritis with or without systemic vasculitis. With 1 exception, the kits had more than 90% agreement with the reference standard and gave results similar to those of research laboratories. IFA diagnostic sensitivity ranged from 81% to 91% and EIA sensitivity from 75% to 84%. Maximum specificity was obtained with combined IFA and EIA. Diagnostic specificity was more than 70% for 2 of 3 IFA kits and at least 90% for 5 of 7 EIA kits. Predictive values varied with clinical manifestations. Most commercial IFA and EIA kits that were evaluated provide acceptably accurate analytic results.     

Rapid detection of methicillin-resistant Staphylococcus aureus from screening enrichment broths by real-time PCR

The aim of this study was to evaluate real-time PCR (LightCycler) kits for the detection of methicillin-resistant Staphylococcus aureus in enrichment broth using 200 sets of patient screening swab samples. One hundred sets were processed using a lysostaphin/lysozyme extraction method and a further 100 were tested using a column extraction kit. The PCR kits with lysostaphin/lysozyme lysis showed 95.7% sensitivity, 90.8% specificity, and negative and positive predictive values of 98.6% and 75.9%, respectively, compared with 88%, 95.9%, 84.6% and 95.9%, respectively, with the column extraction kit.     

Specificity study of kits for detection of group A streptococci directly from throat swabs.

A total of 78 Streptococcus strains, 15 Staphylococcus strains, and 2 Stomatococcus strains were used to test the specificity of 18 different antigen detection systems for group A streptococci and five products that detect a specific enzyme associated with group A streptococci. All streptococcal strains possessing the group A antigen were correctly identified with 31 different lots of reagents in the 18 antigen detection systems. The specificities of the 31 different lots of reagents ranged between 88.5 and 100%. A limited number of nonspecific reactions were observed with Enterococcus gallinarium, group C Streptococcus strain C23, and Staphylococcus aureus F49 and Cowan 1. The antigen detection kits that used enzymes as the extraction reagent gave slightly more specific results than did the kits that used chemical extraction reagents. The reagents in the five kits designed to detect the enzyme pyroglutamic acid arylamidase in Streptococcus pyogenes reacted positively with S. pyogenes (group A streptococcus); however, the reagents also reacted positively with all group D enterococcal streptococci and with about half of the staphylococcal strains treated. The nonspecificity of tests based on pyroglutamic acid arylamidase detection would seem to limit the usefulness of these kits with mixed cultures.     

Evaluation of commercially available third-generation anti-hepatitis C virus enzyme-linked immunosorbent assay in patients on haemodialysis

Restricted antibody reactivity to hepatitis C virus (HCV) synthetic peptides has been observed in HCV-infected patients on haemodialysis (HD). The aim of this study was to evaluate third-generation anti-HCV enzyme-linked immunosorbent assay (ELISA) test systems containing either synthetic peptide HCV antigens or recombinant HCV antigens or a combination of synthetic and recombinant antigens in screening of 69 chronic renal failure patients on HD for HCV infection. Seven patients were detected to have antibodies to HCV by the 'recombinant HCV antigens'-containing kits, of which the recombinant immunoblot assay for HCV confirmed four cases. The recombinant kits had a sensitivity of 100% and a specificity of 66%. However, the ELISA kits with only synthetic HCV antigens failed to detect antibodies in any of the cases (zero sensitivity). Hence a recombinant protein containing ELISA test system is ideal for screening of HCV infection in patients on hemodialysis.     

Comparative evaluation of a latex agglutination test, two Elisa tests and a Western blot test for the serodiagnosis of human trichinellosis

Serology is a helpful test for the diagnosis of human trichinellosis because clinical signs of this disease (fever and myalgias) are non specific. A lot of techniques have been studied but very few are commercialized and have been comparatively evaluated. We report here the performances of 4 commercially available kits: two Elisa tests, one western blot test & one latex agglutination test. The specificity and sensitivity of the different tests were assayed on 60 sera from patients with a proven trichinellosis and on 70 controls. The four tests had a 100% sensitivity. The specificity was of 98.6% for the western blot, of 93% for the latex agglutination test and of 87 & 77% for the two Elisa tests. Cross reactions are mainly observed in patients with other helminthic infections.     

Performance of six influenza rapid tests in detecting human influenza in clinical specimens.

BACKGROUND: The rapid diagnosis of influenza can alter the management of a patient's illness, resulting in reduced antibiotic usage, correct use of influenza antivirals and reduced length of stay in hospital emergency departments. The rapid tests have also been used to detect outbreaks in institutions and may play a role in pandemic influenza control. OBJECTIVES: To test six different rapid influenza tests, in a head-to-head comparison for the detection of seasonal influenza types A and B, compared to laboratory-based tests. STUDY DESIGN: One hundred and seventy-seven clinical specimens taken from mostly paediatric patients between June and October 2006 were tested using six influenza diagnostic tests and three laboratory-based techniques (immunofluorescence, cell culture and real-time RT-PCR). RESULTS AND CONCLUSION: Compared with cell culture, five of the rapid tests (Binax Now Influenza A&B, Directigen EZ Flu A+B, Denka Seiken Quick Ex-Flu, Fujirebio Espline Influenza A&B-N, and Quidel QuickVue Influenza A+B Test) demonstrated a similar influenza A sensitivity of between 67-71% and a specificity of 99-100%, however one rapid test (Rockeby Influenza A Antigen Test) had a significantly lower influenza A sensitivity of only 10% (specificity was 100%). For the five kits that detected influenza B antigen, sensitivity was considerably lower than that seen for influenza A (sensitivity for all the kits was 30%), although the number of specimens containing influenza B viruses was low.