Test Kit Manufacturer Research Articles

International proficiency trial for bovine viral diarrhea virus (BVDV) antibody detection: limitations of milk serology.

BackgroundControl programs were implemented in several countries against bovine viral diarrhea (BVD), one of the most significant cattle diseases worldwide. Most of the programs rely on serological diagnostics in any phase of the program. For the detection of antibodies against BVD virus (BVDV), neutralization tests as well as a variety of (commercially available) ELISAs are used. Here, test systems applied in various laboratories were evaluated in the context of an international interlaboratory proficiency trial. A panel of standardized samples comprising five sera and five milk samples was sent to veterinary diagnostic laboratories (n=51) and test kit manufacturers (n=3).ResultsThe ring trial sample panel was investigated by nine commercially available antibody ELISAs as well as by neutralization tests against diverse BVDV-1, BVDV-2 and/or border disease virus (BDV) strains. The negative serum and milk sample as well as a serum collected after BVDV-2 infection were mostly correctly tested regardless of the applied test system. A serum sample obtained from an animal immunized with an inactivated BVDV-1 vaccine tested positive by neutralization tests or by total antibody or Erns-based ELISAs, while all applied NS3-based ELISAs gave negative results. A further serum, containing antibodies against the ovine BDV, reacted positive in all applied BVDV ELISAs, a differentiation between anti-BDV and anti-BVDV antibodies was only enabled by parallel application of neutralization tests against BVDV and BDV isolates. For the BVDV antibody-positive milk samples (n=4), which mimicked prevalences of 20% (n=2) or 50% (n=2), considerable differences in the number of positive results were observed, which mainly depended on the ELISA kit and the sample incubation protocols used. These 4 milk samples tested negative in 43.6%, 50.9%, 3.6% and 56.4%, respectively, of all investigations. Overall, negative results occurred more often, when a short sample incubation protocol instead of an over-night protocol was applied.ConclusionsWhile the seronegative samples were correctly evaluated in most cases, there were considerable differences in the number of correct evaluations for the seropositive samples, most notably when pooled milk samples were tested. Hence, thorough validation and careful selection of ELISA tests are necessary, especially when applied during surveillance programs in BVD-free regions.

Comparison of Commercial Test Kits for Detection of Salmonella and E. coli O157:H7 in Alfalfa Spent Sprout Irrigation Water.

Sprout growers in the United States are required to test spent sprout irrigation water (SSIW) or in-process sprouts for Escherichia coli O157:H7 and Salmonella species. Pathogen screening kits are commercially available; however, few have been validated for analysis of sprouts or SSIW. This study evaluated AOAC-certified test kits (lateral flow devices [LFDs], enzyme immunoassays [EIAs], and molecular assays) in comparison with culture methods described in the U.S. Food and Drug Administration (FDA) Bacteriological Analytical Manual (BAM) for detection of Salmonella and E. coli O157:H7 in alfalfa SSIW. Twenty-five milliliter aliquots of alfalfa SSIW, either uninoculated or inoculated with Salmonella or E. coli O157:H7 at a low (∼0.5-0.7 CFU/25 mL) or high level (∼10-20 CFU/25 mL), were subjected to the enrichment and assay protocols recommended by each test. Pathogen presence was confirmed following FDA BAM procedures and, if applicable, test kit manufacturer protocols. Twelve of the 13 Salmonella test kits evaluated (except VIDAS UP) performed well and detected Salmonella in 100% of SSIW samples contaminated at 0.61 CFU/mL. Performance varied among E. coli O157:H7 test kits, with four (Reveal, MicroSEQ, GDS, MDA) of 12 kits designed for next-day detection, and four (Reveal, VIP Gold, MicroSEQ, GDS) of seven kits designed for same-day detection capable of detecting the pathogen in 100% samples contaminated at 0.90 CFU/mL. Enrichment conditions play a key role in determining the performance of test kits and the success of confirmation. This study is the first to compare a wide range of commercial test kits for detection of Salmonella and E. coli O157:H7 in SSIW.

Evaluation of arsenic field test kits for drinking water: Recommendations for improvement and implications for arsenic affected regions such as Bangladesh

Arsenic field test kits are widely used to measure arsenic levels in drinking water sources, especially in countries like Bangladesh, where water supply is highly decentralized and water quality testing infrastructure is limited. From a public health perspective, the ability of a measurement technique to distinguish samples above and below relevant and actionable drinking water standards is paramount. In this study, the performance of eight commercially available field test kits was assessed by comparing kit estimates to hydride generation atomic absorption spectroscopy (HG-AAS) analyses. The results of tests that control for user-dependent color matching errors showed that two kits (LaMotte and Quick II kits) provided accurate and precise estimates of arsenic, four kits (Econo-Quick, Quick, Wagtech and Merck kits) were either accurate or precise, but not both, and two kits (Hach and Econo-Quick II kits) were neither accurate nor precise. Tests were performed for arsenic concentration ranges commonly found in natural waters and treated waters (such as community drinking water filter systems), and also on laboratory generated arsenic standards in DI water. For those kits that did not perform well, test strips often produced colors too light compared to manufacturer-provided arsenic color calibration charts. Based on these results, we recommend stakeholders carefully re-consider the use of poorly performing field test kits until better quality control of components of these kits is implemented. In addition, we recommend that field test kit manufacturers provide suitable internal standards in every kit box for users to verify the veracity of manufacturer provided color charts.

Sex differences in risk factors for subclinical hypothyroidism.

ObjectiveTo investigate the prevalence of subclinical hypothyroidism (SCH) in Korean adults and identify the risk factors for the occurrence of SCH by sex.Design and methodsThis study used data from the Sixth Korea National Health and Nutrition Examination Survey (KNHANES VI), a cross-sectional, nationally representative survey, which comprises a health interview survey, a health examination survey and a nutrition survey. To examine SCH, the reference range of thyroid-stimulating hormone (TSH) was defined using both the range provided by the test kit manufacturer (SCH-M) and a population-based range (SCH-P). We investigated the prevalence of SCH and its risk factors by sex using both reference ranges.ResultsThe prevalence of SCH in Koreans according to SCH-M (0.35–5.5 µIU/mL) was 5.6%, and 3.3% with SCH-P (0.62–6.68 µIU/mL). For men, smoking significantly reduced the incidence of SCH, positive anti-thyroid peroxidase antibody (TPOAb) significantly increased the risk of SCH, and in an adjusted model, the risk of SCH in all quartiles increased as the urine iodine creatinine ratio (UICR) quartile increased. For women, positive TPOAb was confirmed as a risk factor for SCH, as was the highest UICR quartile. Furthermore, the odds ratio for SCH in urban vs rural residence was 1.78.ConclusionsThe prevalence rates of SCH were similar to those reported in the literature and previously known risk factors were confirmed using both TSH reference ranges. The notable findings from this study are that the increased risk of SCH with increased iodine intake was more marked in men than in women and that residential area may be a risk factor for SCH in women.

Performance Evaluation of a Serum S-100B ELISA for Use with Cerebrospinal Fluid

To the Editor: Various studies have reported cerebrospinal fluid (CSF) S-100B concentrations to be valuable prognostic markers for patients suffering brain trauma (1–4). However, the vast majority of the literature regarding the performance of S-100B testing methodologies focuses on the quantification of the protein in serum, not in CSF. In this report, we describe a performance evaluation of the CanAg® S100 EIA (Fujirebio Diagnostics, Inc.), a 96-well microtiter plate formatted immunoassay intended for quantifying S-100B in serum (5), for use with human CSF. CSF S-100B was measured according to the test kit manufacturer's protocol. Residual CSF specimens were deidentified according …

Validation of Antibody-Based Strategies for Diagnosis of Pediatric Celiac Disease Without Biopsy

A diagnosis of celiac disease is made based on clinical, genetic, serologic, and duodenal morphology features. Recent pediatric guidelines, based largely on retrospective data, propose omitting biopsy analysis for patients with concentrations of IgA against tissue transglutaminase (IgA-TTG) >10-fold the upper limit of normal (ULN) and if further criteria are met. A retrospective study concluded that measurements of IgA-TTG and total IgA, or IgA-TTG and IgG against deamidated gliadin (IgG-DGL) could identify patients with and without celiac disease. Patients were assigned to categories of no celiac disease, celiac disease, or biopsy required, based entirely on antibody assays. We aimed to validate the positive and negative predictive values (PPV and NPV) of these diagnostic procedures. We performed a prospective study of 898 children undergoing duodenal biopsy analysis to confirm or rule out celiac disease at 13 centers in Europe. We compared findings from serologic analysis with findings from biopsy analyses, follow-up data, and diagnoses made by the pediatric gastroenterologists (celiac disease, no celiac disease, or no final diagnosis). Assays to measure IgA-TTG, IgG-DGL, and endomysium antibodies were performed by blinded researchers, and tissue sections were analyzed by local and blinded reference pathologists. We validated 2 procedures for diagnosis: total-IgA and IgA-TTG (the TTG-IgA procedure), as well as IgG-DGL with IgA-TTG (TTG-DGL procedure). Patients were assigned to categories of no celiac disease if all assays found antibody concentrations <1-fold the ULN, or celiac disease if at least 1 assay measured antibody concentrations >10-fold the ULN. All other cases were considered to require biopsy analysis. ULN values were calculated using the cutoff levels suggested by the test kit manufacturers. HLA typing was performed for 449 participants. We used models that considered how specificity values change with prevalence to extrapolate the PPV and NPV to populations with lower prevalence of celiac disease. Of the participants, 592 were found to have celiac disease, 345 were found not to have celiac disease, and 24 had no final diagnosis. The TTG-IgA procedure identified patients with celiac disease with a PPV of 0.988 and an NPV of 0.934; the TTG-DGL procedure identified patients with celiac disease with a PPV of 0.988 and an NPV of 0.958. Based on our extrapolation model, we estimated that the PPV and NPV would remain >0.95 even at a disease prevalence as low as 4%. Tests for endomysium antibodies and HLA type did not increase the PPV of samples with levels of IgA-TTG ≥10-fold the ULN. Notably, 4.2% of pathologists disagreed in their analyses of duodenal morphology-a rate comparable to the error rate for serologic assays. In a prospective study, we validated theTTG-IgA procedure and the TTG-DGL procedure in identification of pediatric patients with or without celiac disease, without biopsy. German Clinical Trials Registry no.: DRKS00003854.

Study of baseline Widal titres in a healthy adult population of Wayanad district, Kerala, India.

The Widal test is still widely used in diagnosing typhoid fever in developing countries. Often, specific chemotherapy is administered based on a single Widal test. Interpretation of a single Widal test, in turn, depends on the baseline agglutinin titres among the local population in that area. Hence, we aimed to find out the baseline titres in our area. A single blood sample was collected from hospital outpatients with non-infectious diseases, the patients being aged above 18 years and residing in Wayanad district continuously for at least 5 years. The test was performed according to the Widal test kit manufacturer's instructions and interpreted using standard guidelines. The baseline titre for Anti TO, TH, AH and BH agglutinins in our area was found to be 1:40, 1:80, 1:40 and 1:40, respectively.

Perceptions of point-of-care infectious disease testing among European medical personnel, point-of-care test kit manufacturers, and the general public.

BackgroundThe proper development and implementation of point-of-care (POC) diagnostics requires knowledge of the perceived requirements and barriers to their implementation. To determine the current requirements and perceived barriers to the introduction of POC diagnostics in the field of medical microbiology (MM)-POC a prospective online survey (TEMPOtest-QC) was established.Methods and resultsThe TEMPOtest-QC survey was online between February 2011 and July 2012 and targeted the medical community, POC test diagnostic manufacturers, general practitioners, and the general public. In total, 293 individuals responded to the survey, including 91 (31%) medical microbiologists, 39 (13%) nonmedical microbiologists, 25 (9%) employees of POC test manufacturers, and 138 (47%) members of the general public. Responses were received from 18 different European countries, with the largest percentage of these living in The Netherlands (52%). The majority (>50%) of medical specialists regarded the development of MM-POC for blood culture and hospital acquired infections as “absolutely necessary”, but were much less favorable towards their use in the home environment. Significant differences in perceptions between medical specialists and the general public included the: (1) Effect on quality of patient care; (2) Ability to better monitor patients; (3) Home testing and the doctor-patient relationship; and (4) MM-POC interpretation. Only 34.7% of the general public is willing to pay more than a€10 ($13) for a single MM-POC test, with 85.5% preferring to purchase their MM-POC test from a pharmacy.ConclusionThe requirements for the proper implementation of MM-POC were found to be generally similar between medical specialists and POC test kit manufacturers. The general public was much more favorable with respect to a perceived improvement in the quality of healthcare that these tests would bring to the hospital and home environment.

European Proficiency Study with Control Serum for the Tumor Marker CA 19-9 Measured on Different Test Systems

Reliable and precise CA 19-9 testing is required for the long-term follow-up of patients with pancreatic carcinoma during therapy. The aim of this longitudinal proficiency study was to evaluate the comparability, linearity, and precision of CA 19-9 determinations performed in different laboratories using currently available test systems under routine conditions. During the one year study period, 15 laboratories applied 7 different tests and included a liquid BIOREF control serum with pancreatic carcinoma derived CA 19-9 in their routine testing and quality control procedures. The results were collected centrally and evaluated statistically. The comparability of CA 19-9 results is limited especially when different tests are used, albeit, some tests show a good correlation: The CA 19-9 values obtained by different laboratories using different test systems vary up to a factor of 2. The precision of CA 19-9 determinations was acceptable in most laboratories with coefficients of variation ranging between very low 3.2% and high 17.8%. The imprecision was slightly increased when automatic dilution procedures of the analysers were used. The comparability of CA 19-9 test results must be improved. The precision is acceptable in most cases. In order to monitor key performance parameters, every laboratory should participate in external quality assessment schemes and should perform a routine internal quality control with a control serum independent from the test kit manufacturer.

EU-Approved Rapid Tests for Bovine Spongiform Encephalopathy Detect Atypical Forms: A Study for Their Sensitivities

Since 2004 it become clear that atypical bovine spongiform encephalopthies (BSEs) exist in cattle. Whenever their detection has relied on active surveillance plans implemented in Europe since 2001 by rapid tests, the overall and inter-laboratory performance of these diagnostic systems in the detection of the atypical strains has not been studied thoroughly to date. To fill this gap, the present study reports on the analytical sensitivity of the EU-approved rapid tests for atypical L- and H-type and classical BSE in parallel. Each test was challenged with two dilution series, one created from a positive pool of the three BSE forms according to the EURL standard method of homogenate preparation (50% w/v) and the other as per the test kit manufacturer's instructions. Multilevel logistic models and simple logistic models with the rapid test as the only covariate were fitted for each BSE form analyzed as directed by the test manufacturer's dilution protocol. The same schemes, but excluding the BSE type, were then applied to compare test performance under the manufacturer's versus the water protocol. The IDEXX HerdChek ® BSE-scrapie short protocol test showed the highest sensitivity for all BSE forms. The IDEXX® HerdChek BSE-scrapie ultra short protocol, the Prionics® - Check WESTERN and the AJ Roboscreen® BetaPrion tests showed similar sensitivities, followed by the Roche® PrionScreen, the Bio-Rad® TeSeE™ SAP and the Prionics® - Check PrioSTRIP in descending order of analytical sensitivity. Despite these differences, the limit of detection of all seven rapid tests against the different classes of material set within a 2 log10 range of the best-performing test, thus meeting the European Food Safety Authority requirement for BSE surveillance purposes. These findings indicate that not many atypical cases would have been missed surveillance since 2001 which is important for further epidemiological interpretations of the sporadic character of atypical forms.

The Non-Specificity of the Duquenois-Levine Field Test for Marijuana

The purpose of this study is to determine the specificity, or lack thereof, of the Duquenois-Levine (D-L) field test kit in the identification of marijuana. Out of the forty-two samples tested, patchouli, spearmint, and eucalyptus tested positive for marijuana using the D-L field test. From these results, it can be concluded that the test is non-specific and can yield false positives. Therefore, it cannot be legitimately used for the prosecution or conviction of an individual for violations of the anti-marijuana laws as it does not provide proof beyond a reasonable doubt of the presence of marijuana. In fact, law enforcement personnel and the test kit manufacturer claim that the D-L field test is a specific, identification test with near perfect accuracy. In court, police officers testify falsely to the identification of marijuana in a seized substance based solely on the D-L test and other non-specific, screening tests leading to convictions. The result is the denial of the Constitutionally-guaranteed right to a fair trial, due process and countless wrongful marijuana convictions.

Allergen determination in food: reference materials and traceability of results

Food allergens are more or less denatured mixtures of non-defined proteins in complex matrices. The most common technique to measure these proteins is an antibody-based system as, e.g., a commercial ELISA system which consists of an extraction procedure, suitable antibodies and a calibrator. Until now, only a few attempts to standardize these different ELISA systems were performed and the most promising way seems to be a standardization of the calibrator. It is shown that we have currently no methods to fully characterize these calibrators, which are always complex protein mixtures. This also means that the production of reference materials containing these calibrators is not possible. It is proposed to choose a different way because we will never have an unbroken traceability chain. As described in ISO 17511:2003 for the clinical area, one possibility could be the selection of a commercial preparation (e.g. skim milk powder) to which all test kit manufacturers will relate their results on and in a second step to select a reference method.

ELISA and HPLC analysis of Ochratoxin A in red wine collected in Croatia

Ochratoxin A (OTA) is nephrotoxic and carcinogen mycotoxin that contaminates various commodities including wine all round the world. It was found that wine consumption might significantly increase human exposure to this toxin. In this study, enzyme-linked immunosorbent assay (ELISA) and high performance liquid chromatography (HPLC) for OTA analysis were tested on red must and wine samples collected in Croatia. Must samples were also tested for the presence of A. carbonarius. HPLC analysis was performed according to previously described method that includes solid phase extraction on the immuonoaffinity columns (OchraTest, Vicam, MA, USA). The standard curve was linear (r2=0.9987) and the detection limit was 5 ng/L. ELISA method performed according to the test kit manufacturer’ s instructions (I’ screen Ochratoxin A) gave unrealistically high values of OTA concentrations indicating the presence of impurities. Therefore, a step with bicarbonate purification was added. The intensity of the resulting yellow color was measured at 450 nm on the microplate reader (Victor 3, Perkin Elmer, Shelton, CT, USA). The OTA concentration was calculated comparing to standards provided by manufacturer, and the detection limit was 0.1 ng/ml. The results of ELISA and HPLC analysis of OTA in naturally contaminated red wines correlated well (r=0.821), and the correlation was better at higher OTA concentrations. In contrast to HPLC, ELISA could not detect very low OTA concentrations. OTA concentrations in must (range 19-50 ng/L) were higher than in the wines (range 0-21 ng/L). No must samples showed the presence of A. carbonarius, which is a common OTA-producing mould affecting grapes.

Problem Solved? West Nile Virus and Transfusion Safety

In 2002, just three years after its appearance in the Western Hemisphere, West Nile virus caused the largest outbreak of arboviral encephalitis ever recorded in the United States.1 Epidemiologic investigations that year revealed that West Nile virus could be transmitted by blood transfusion,2 and mathematical models suggested that hundreds of transmissions had occurred.3 By July 2003, shortly before a second seasonal outbreak of similar magnitude began, collaborations among blood-collection organizations, test-kit manufacturers, and government agencies culminated in near-universal screening of U.S. blood donations for West Nile virus with the use of newly developed nucleic acid amplification tests.In this issue . . .

A comparison of human chorionic gonadotropin- related components in fresh frozen serum with the proficiency testing material used by the College of American Pathologists.

Abstract Context.—As part of a College of American Pathologists (CAP) proficiency testing survey, a comparison is made between human chorionic gonadotropin (hCG) results from an actual patient pool and a similarly targeted artificial sample. The goal is to gain insight into the possible source(s) of bias attributable to the proficiency testing material (PTM) with a view toward creating more appropriate survey materials. Objective.—To compare hCG and related variants in a pool of fresh frozen sera (FFS) with that found in PTM. Design.—The 2003 CAP K/KN-A Survey included a FFS specimen along with admixtures of PTM. The FFS (K-02) and 1 PTM admixture (K-01) had similar mean hCG values. Five hCG-related analytes were measured on these 2 samples by a reference laboratory. Participants.—Approximately 1800 clinical laboratories and diagnostic test kit manufacturers participated in the K/ KN-A Survey. Main Outcome Measures.—Method imprecision (coefficient of variation) and method bias (relative difference between...

A Comparison of Human Chorionic Gonadotropin– Related Components in Fresh Frozen Serum With the Proficiency Testing Material Used by the College of American Pathologists

As part of a College of American Pathologists (CAP) proficiency testing survey, a comparison is made between human chorionic gonadotropin (hCG) results from an actual patient pool and a similarly targeted artificial sample. The goal is to gain insight into the possible source(s) of bias attributable to the proficiency testing material (PTM) with a view toward creating more appropriate survey materials. To compare hCG and related variants in a pool of fresh frozen sera (FFS) with that found in PTM. The 2003 CAP K/KN-A Survey included a FFS specimen along with admixtures of PTM. The FFS (K-02) and 1 PTM admixture (K-01) had similar mean hCG values. Five hCG-related analytes were measured on these 2 samples by a reference laboratory. Approximately 1800 clinical laboratories and diagnostic test kit manufacturers participated in the K/ KN-A Survey. Method imprecision (coefficient of variation) and method bias (relative difference between peer group mean and all-method median) were computed for the 2 samples. Differences were evaluated with respect to hCG-related analytes levels. All-method hCG results were 12.9 mIU/mL (12.9 IU/L) for the PTM material and 21.6 mIU/mL (21.6 IU/L) for the FFS material. Method biases for 14 manufacturers were greater for PTM than for FFS (-40% to +35% and -16% to +23%). Twelve of 14 methods had higher coefficients of variation on PTM. Total hCG and free beta hCG measurements by the reference laboratory were 14.1 mIU/ mL (14.1 IU/L) for the PTM material and 18.5 mIU/mL (18.5 U/L) for the FFS material (FFS), and 2.4 (PTM) and 0.7 (FFS) mIU/mL (2.4 and 0.7 IU/L), respectively. On a molar basis, free beta represented 17% and 4% of the total hCG, respectively. Levels of hyperglycosylated hCG, nicked hCG, and beta core fragment were not measurable in either sample. It is unlikely that the hCG added to the PTM is the source of the increased bias and variability. The main difference is a 3-fold increase in free beta found in the PTM, but methods previously found to strongly react with free beta were not systematically elevated. The biases between manufacturers found for the FFS specimen are likely attributable to calibration differences.

Report of EPFA/NIBSC workshop 'nucleic acid amplification tests (NAT) for the detection of blood-borne viruses' held on 31 October 1996 in Amsterdam, The Netherlands.

The 3rd annual European Plasma Fractionators Association/National Institut of Biological Standard and Control (EPFA/NIBSC) meeting provided a forum for regulators, blood product and test kit manufacturers and organisations developing standards to present and discuss their latest data. The main conclusions were as follows. There has been substantial progress during the last year in the development of NAT technology specifically for improving the safety of blood products though there is an urgent need for the development of international reference materials. The technology is not yet sufficiently developed to be used as a routine screening test though testing of plasma pools for hepatitis C virus may be achieved within a year. Introduction of testing should not result in the creation of dual standards for plasma derived and cellular products. Once the technology is fully developed it could significantly improve the safety of all blood products, particularly those derived from starting materials with a high incidence of viral markers.

Report of EPFA/NIBSC Workshop 'Nucleic Acid Amplification Tests (NAT) for the Detection of Blood-Borne Viruses' Held on 31 October 1996 in Amsterdam, The Netherlands

The 3rd annual European Plasma Fractionators Association/National Institut of Biological Standard and Control (EPFA/NIBSC) meeting provided a forum for regulators, blood product and test kit manufacturers and organisations developing standards to present and discuss their latest data. The main conclusions were as follows. There has been substantial progress during the last year in the development of NAT technology specifically for improving the safety of blood products though there is an urgent need for the development of international reference materials. The technology is not yet sufficiently developed to be used as a routine screening test though testing of plasma pools for hepatitis C virus may be achieved within a year. Introduction of testing should not result in the creation of dual standards for plasma derived and cellular products. Once the technology is fully developed it could significantly improve the safety of all blood products, particularly those derived from starting materials with a high incidence of viral markers.

Neither Skin Tests nor Serum Enzyme-Linked Immunosorbent Assay Tests Provide Specificity for Protamine Allergy

Neither Skin Tests nor Serum Enzyme-Linked Immunosorbent Assay Tests Provide Specificity for Protamine Allergy

India BLOOD PRODUCTS BAN

In 1989 India banned all domestically produced blood based products from being sold or manufactured because HIV antibodies were detected in some samples of domestically manufactured anti-Rh(D) immunoglobulin. The ban also included antirabies tetanus and hepatitis B immunoglobulins factor VIII and platelet concentrated. Further regulations were liberalized to allow import of these products. None of the 9 manufacturers in India had properly screened donors for HIV or recorded their HIV status. Therefore the government approved the revised Health Ministry regulations which required HIV screening of each unit of blood pooled plasma and the final product and inactivating HIV using a fractionation technique with a proven viricidal technique. These reactions prompted a severe shortage of blood products. Some physicians believed a more rational approach would have been warranted such as require monitoring of all blood products rather than risk lives due to a shortage of blood products. A few manufacturers found that none of their tested batches had HIV antibodies. After the start of the controversy researchers at the All India Institute of Medical Sciences tested 183 vials of blood products from manufacturers and found 32 confirmed HIV positive vials including 1 vial of albumin. The Serum Institute of India Ltd. revealed that it unknowingly purchased 3 lots of defective ELISA AIDS test kids from the West German company Hoechst at a discount. Hoechst dumped them on India after the Paul Ehrlich Institute recalled them from the European market. The Indian company had conducted 1000s of tests with these kits since August 1988 leading to contamination of its blood products. Upon contacting the Paul Ehrlich Institute in March 1989 it learned of the recall. This even led to a requirement that each test kit manufacturer send a certificate of quality with each consignment.